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
40681–40704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2013
NEUROBLATE(TM) SYSTEM
K131955 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 33d
Cleared Jul 30, 2013
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT,...
K132008 · DTD
Medtronic, Inc.
Cardiovascular · 29d
Cleared Jul 29, 2013
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM...
K122091 · MPB
Cook, Inc.
Gastroenterology & Urology · 378d
Cleared Jul 29, 2013
OPHTACATH KIT
K123831 · OKS
France Chirurgae Instrumentation
Ophthalmic · 229d
Cleared Jul 29, 2013
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
K130059 · PBQ
Ibi Israel Biomedical Innovations , Ltd.
Obstetrics & Gynecology · 200d
Cleared Jul 29, 2013
ANGIOJET ULTRA POWER PULSE KIT
K130381 · QEW
Medrad, Inc.
Cardiovascular · 165d
Cleared Jul 29, 2013
PTFE SUPER SHEATH INTRODUCER
K130855 · DYB
Martech Medical Products
Cardiovascular · 123d
Cleared Jul 29, 2013
MULTIFIX S KNOTLESS FIXATION DEVICE
K131182 · MBI
Arthocare Corporation
Orthopedic · 94d
Cleared Jul 29, 2013
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
K131361 · DWJ
Covidien
Cardiovascular · 77d
Cleared Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 48d
Cleared Jul 26, 2013
TETRACHROME REAGENTS AND TETRACXP SYSTEM
K121445 · OYE
Beckman Coulter, Inc.
Hematology · 437d
Cleared Jul 26, 2013
VDRIVE W/V-SONO
K122659 · DQX
Stereotaxis, Inc.
Cardiovascular · 329d
Cleared Jul 26, 2013
GMK REVISION EXTENSION
K123721 · JWH
Medacta International
Orthopedic · 234d
Cleared Jul 26, 2013
RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
K123768 · NZA
STERIS Corporation
General Hospital · 231d
Cleared Jul 26, 2013
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE...
K130331 · MVN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Jul 26, 2013
DENTAL UNIT WITH CHAIR
K130410 · EIA
Xianyang North West Medical...
Dental · 157d
Cleared Jul 26, 2013
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K130478 · MAX
Globus Medical, Inc.
Orthopedic · 151d
Cleared Jul 26, 2013
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2...
K130500 · CEF
Sebia
Immunology · 150d
Cleared Jul 26, 2013
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
K130623 · KNS
Covidien, LLC
Gastroenterology & Urology · 140d
Cleared Jul 26, 2013
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
K130680 · EBI
Dentsoll, Inc.
Dental · 135d
Cleared Jul 26, 2013
SEER 1000
K130785 · MWJ
Getemed Medizin- Und...
Cardiovascular · 127d
Cleared Jul 26, 2013
ZIRMON SERIES
K131117 · EIH
Kuwotech Co., Ltd.
Dental · 95d
Cleared Jul 26, 2013
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
K131264 · HWC
Gebr. Brasseler GmbH & Co. KG
Orthopedic · 84d
Cleared Jul 26, 2013
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND...
K131448 · LLZ
Koelis
Radiology · 67d