Search FDA 510(k) Database

6,642 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
11353–11376 of 174,061
Cleared Sep 14, 2022
LightForce Orthodontic System
K222764 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Sep 13, 2022
MagiCath II
K210929 · FOZ
Woo Young Medical Co., Ltd.
General Hospital · 533d
Cleared Sep 13, 2022
Simplexa COVID-19 Direct
K212147 · QQX
Diasorin Molecular, LLC
Microbiology · 431d
Cleared Sep 13, 2022
Female IC (Not Finalized)
K213575 · EZD
Hollister Incorporated
Gastroenterology & Urology · 307d
Cleared Sep 13, 2022
SP-CL Hip Stem and LCU Hip System
K213770 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 285d
Cleared Sep 13, 2022
LAITEST Medical Face Mask
K214035 · FXX
R&R Medical Corporation, Ltd.
General Hospital · 264d
Cleared Sep 13, 2022
Solid State X-ray Imager(Model: FXRD-4386WB)
K220239 · MQB
Vieworks Co., Ltd.
Radiology · 228d
Cleared Sep 13, 2022
ChoiceSpine TigerShark™ M, Modular Interbody System
K220953 · MAX
Choice Spine, LLC
Orthopedic · 165d
Cleared Sep 13, 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · NUH
Shenzhen Future Electronic Co., Ltd.
Neurology · 153d
Cleared Sep 13, 2022
P20 Elite Series Digital Color Doppler Ultrasound System
K221140 · IYN
Sonoscape Medical Corp.
Radiology · 147d
Cleared Sep 13, 2022
CLAROX plus (Model: VX-100)
K221417 · IZL
Vsi Co., Ltd.
Radiology · 120d
Cleared Sep 13, 2022
Primary Relief
K221425 · NHI
Dyansys, Inc.
Neurology · 120d
Cleared Sep 13, 2022
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
K221733 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Sep 13, 2022
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K221748 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 89d
Cleared Sep 12, 2022
SOFIA 88 Catheter
K214024 · DQY
MicroVention, Inc.
Neurology · 264d
Cleared Sep 12, 2022
Infrared Forehead Thermometer
K220084 · FLL
Qingdao Yasee Medical Device Co., Ltd.
General Hospital · 245d
Cleared Sep 12, 2022
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
K220986 · JAK
Canon Medical Systems Corporation
Radiology · 161d
Cleared Sep 12, 2022
Phosphoric Acid Etching Gel
K221450 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 117d
Cleared Sep 12, 2022
Rapid ICH
K221456 · QAS
Ischemaview, Inc.
Radiology · 116d
Cleared Sep 12, 2022
Plasma Shield
K221533 · GCJ
Plasmatica, Ltd.
General & Plastic Surgery · 108d
Cleared Sep 12, 2022
KOLO Evolution XHD Series Ultrasound Diagnostic System
K221568 · IYN
Kolo Medical (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Sep 12, 2022
Integrity-SI Fusion System
K222512 · OUR
OsteoCentric Technologies
Orthopedic · 24d
Cleared Sep 09, 2022
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set,...
K213244 · ELW
Prevest Denpro Limited
Dental · 344d
Cleared Sep 09, 2022
MICOR Lens Fragmentation System
K214028 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d