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
43873–43896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2012
ANA-SCREEN WITH MDSS
K113610 · LKJ
Bio-Rad Laboratories
Immunology · 216d
Cleared Jul 09, 2012
THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET,...
K120305 · LLZ
Thinking Systems Corp.
Radiology · 159d
Cleared Jul 09, 2012
SEVIIN REVERSE SHOULDER
K120374 · PHX
Ingen Orthopedics, LLC
Orthopedic · 154d
Cleared Jul 09, 2012
OXYBAND WOUND DRESSING
K121407 · FRO
O2s, LLC
General & Plastic Surgery · 60d
Cleared Jul 09, 2012
S-SCAN
K121650 · LNH
Esaote, S.P.A.
Radiology · 34d
Cleared Jul 06, 2012
NAVIS TORQUER
K112674 · DQX
Navis Medical,Inc
Cardiovascular · 296d
Cleared Jul 06, 2012
SMARTDRIVE WHEELCHAIR POWER-ASSIST
K113621 · ITI
Max Mobility, LLC
Physical Medicine · 211d
Cleared Jul 06, 2012
SAFETY SUBCUTANEOUS TISSUE INFUSION SET
K120195 · FPA
Multi Med
General Hospital · 165d
Cleared Jul 06, 2012
MECHANICAL WHEELCHAIR
K120302 · IQC
Novaf Andalucia 2007, SL
Physical Medicine · 156d
Cleared Jul 06, 2012
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
K120468 · GCJ
Cook Incorporated
General & Plastic Surgery · 141d
Cleared Jul 06, 2012
HEATLUX
K120582 · ILY
Home Skinovations , Ltd.
Physical Medicine · 130d
Cleared Jul 06, 2012
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
K120649 · NBW
Apex BioTechnology Corp.
Chemistry · 126d
Cleared Jul 06, 2012
FLIGHT 60 VENTILATOR
K120726 · CBK
Flight Medical Innovations , Ltd.
Anesthesiology · 119d
Cleared Jul 06, 2012
SYNTHES MULTILOC HUMERAL NAILING SYSTEM
K120807 · HSB
Synthes USA Products, LLC
Orthopedic · 112d
Cleared Jul 06, 2012
SUNFLOWER WARNER
K120937 · FMT
Atom Medical Corporation
General Hospital · 100d
Cleared Jul 06, 2012
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
K121030 · LRX
Sacks Holdings, Inc.
Ophthalmic · 92d
Cleared Jul 06, 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121096 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 86d
Cleared Jul 06, 2012
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K121125 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 06, 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL...
K121601 · HRS
Synthes (Usa)
Orthopedic · 35d
Cleared Jul 05, 2012
ILUMINAGE DIODE LASER
K111454 · OHS
Cynosure, Inc.
General & Plastic Surgery · 407d
Cleared Jul 05, 2012
BIOPURE PORTABLE RO SYSTEMS
K112331 · FIP
Arion Water, Inc.
Gastroenterology & Urology · 328d
Cleared Jul 05, 2012
BD MAX MRSA ASSAY, BD MAX INSTRUMENT
K120138 · NQX
Bd Diagnostics (Geneohm Sciences...
Microbiology · 170d
Cleared Jul 05, 2012
SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
K120244 · ONT
Nexera Medical, Inc.
General Hospital · 160d
Cleared Jul 05, 2012
ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN...
K120338 · NHA
Astra Tech, Inc.
Dental · 153d