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
42337–42360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2013
BEST LOCALIZATION NEEDLE WITH I-125 SEED
K122704 · KXK
Best Medical Intl.
Radiology · 127d
Cleared Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL...
K122914 · DTN
Medtronic, Inc.
Cardiovascular · 110d
Cleared Jan 09, 2013
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
K123213 · ONB
Becton, Dickinson & CO
General Hospital · 86d
Cleared Jan 09, 2013
STRYKER CROSSFLOW ARTHROSCOPY PUMP
K123441 · HRX
Stryker Endoscopy
Orthopedic · 62d
Cleared Jan 09, 2013
TRANSTEK GLASS BODY FAT ANALYZER
K123781 · MNW
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jan 09, 2013
LIQUIDCHEK DIABETES CONTROL
K123798 · JJX
Bio-Rad Laboratories
Chemistry · 30d
Cleared Jan 09, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K123863 · DKZ
Ucp Biosciences, Inc.
Toxicology · 26d
Cleared Jan 08, 2013
ASAP MUITISCOPE
K121261 · HRX
Asap Endoscopic Products GmbH
Orthopedic · 257d
Cleared Jan 08, 2013
SOLOCEM
K121621 · EMA
Coltene/Whaledent AG
Dental · 221d
Cleared Jan 08, 2013
COLLAGEN TENDON SHEET-D
K122048 · FTM
Rotation Medical, Inc.
General & Plastic Surgery · 180d
Cleared Jan 08, 2013
AEQUALIS ASCEND FLEX SHOULDER SYSTEM
K122698 · KWS
Tornier S.A.S.
Orthopedic · 126d
Cleared Jan 08, 2013
FALCON SPACER
K123180 · MAX
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Jan 08, 2013
ALIGNRT PLUS
K123371 · IYE
Vision RT Limited
Radiology · 68d
Cleared Jan 08, 2013
MEGA 5.5 SPINE SYSTEM
K123476 · MNH
Lsk Biopartners, Inc.
Orthopedic · 56d
Cleared Jan 08, 2013
MALLEABLE TIP ENDOSCOPIC APPLICATOR
K123847 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 25d
Cleared Jan 08, 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION...
K123868 · FPA
Baxter Healthcare Corp
General Hospital · 22d
Cleared Jan 07, 2013
TS IMPLANT SYSTEM
K121585 · DZE
Osstem Implant Co., Ltd.
Dental · 221d
Cleared Jan 07, 2013
AVIE TOTAL HB TEST SYSTEM
K121752 · GKR
Mec Dynamics Corp
Hematology · 207d
Cleared Jan 07, 2013
ENTEROCOCCUS QUICKFISH BC
K121991 · OAH
Advandx, Inc.
Microbiology · 185d
Cleared CT Jan 07, 2013
BRAINSWAY DEEP TMS SYSTEM
K122288 · OBP
Brainsway , Ltd.
Neurology · 161d
Cleared Jan 07, 2013
VANTAGE MODEL V5000, V5100, V5000C, V5100C
K122643 · MUH
Midmark Corp.
Radiology · 131d
Cleared Jan 04, 2013
THERASOM-CAST
K113516 · LRK
Family Dental Services, P.C.
Dental · 402d
Cleared Jan 04, 2013
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K113787 · MKJ
Defibtech, LLC
Cardiovascular · 379d
Cleared Jan 04, 2013
INSTINCT JAVA SYSTEM
K122592 · MNH
Zimmer Spine
Orthopedic · 133d