Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
52681–52704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
K092179 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Jul 28, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
K083052 · MST
Euroimmun Us, Inc.
Immunology · 287d
Cleared Jul 28, 2009
PMT HALO SYSTEM
K090733 · HAX
Pmt Corp.
Neurology · 131d
Cleared Jul 28, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
K090828 · LZA
Ultrawin Sdn Bhd
General Hospital · 124d
Cleared Jul 28, 2009
AL T LASER, MODEL AVI HPLL-12
K091285 · ILY
Avicenna Laser Technology, Inc.
Physical Medicine · 88d
Cleared Jul 28, 2009
PHILIPS NM3 MONITOR, MODEL 7900
K091459 · BZK
Respironics Novametrix, LLC
Anesthesiology · 71d
Cleared Jul 28, 2009
HAEMOBAND MULTI-LIGATOR
K091519 · FHN
Haemoband Surgical, Ltd.
Gastroenterology & Urology · 67d
Cleared Jul 28, 2009
SHARP CHUTE
K091690 · MMK
Heathrow Scientific, LLC
General Hospital · 48d
Cleared Jul 28, 2009
PLS PORTABLE LIGHT SOURCE
K091829 · NTN
Optim, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 28, 2009
NAVIJECT SUB2-1P, MODEL: LP604430
K092023 · MSS
Medicel AG
Ophthalmic · 22d
Cleared Jul 28, 2009
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K092159 · IYN
Medison Co., Ltd.
Radiology · 12d
Cleared Jul 27, 2009
ACCUPEN
K083377 · HKX
Accutome Ultrasound, Inc.
Ophthalmic · 255d
Cleared Jul 27, 2009
SONOLITH I-SYS LITHOTRIPER
K083614 · LNS
Technomed Medical Systems, SA
Gastroenterology & Urology · 231d
Cleared Jul 27, 2009
SPI DENTAL IMPLANT INICELL
K090154 · DZE
Thommen Medical AG
Dental · 186d
Cleared Jul 27, 2009
ALPINE PEDICLE SCREW SYSTEM
K090477 · MNH
Sanacor
Orthopedic · 153d
Cleared Jul 27, 2009
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS...
K090699 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 132d
Cleared Jul 27, 2009
THERMOFLO HCH, THERMOFLO FILTER
K090738 · CAH
Arc Medical, Inc.
General Hospital · 129d
Cleared Jul 27, 2009
WALK400H
K091054 · MWJ
Et Medical Devices Spa
Cardiovascular · 105d
Cleared Jul 27, 2009
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K091147 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 98d
Cleared Jul 27, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K091661 · LYZ
Zhang Jia Gang Huayuan Plastic Co. ,...
General Hospital · 48d
Cleared Jul 27, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K091663 · LYZ
Zhangjiagang Fengyuan Plastic...
General Hospital · 48d
Cleared Jul 27, 2009
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
K092122 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 13d
Cleared Jul 24, 2009
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
K081603 · DXR
Heartforce Medical, Inc.
Cardiovascular · 413d
Cleared Jul 24, 2009
NUBIC AND RABEA DEVICES
K082848 · ODP
Signus Medizintechnik GmbH
Orthopedic · 298d