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
52417–52440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2009
LAGIS ENDOSCOPIC INSTRUMENTS
K090309 · GEI
Lagis Enterprises Co, Ltd.
General & Plastic Surgery · 203d
Cleared Aug 28, 2009
SINUS QUICK EB SYSTEM
K090377 · DZE
Neobiotech Co., Ltd.
Dental · 192d
Cleared Aug 28, 2009
LEDA
K090762 · GEX
Quantel Derma GmbH
General & Plastic Surgery · 158d
Cleared Aug 28, 2009
VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
K091419 · LFD
The Procter & Gamble Co.
Dental · 107d
Cleared Aug 28, 2009
PRIMER PLUS
K091705 · KLE
Bisco, Inc.
Dental · 79d
Cleared Aug 28, 2009
QUATTRO PORCELAIN SYSTEM
K091706 · EIH
Dentsply International, Inc.
Dental · 79d
Cleared Aug 28, 2009
VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
K091733 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 78d
Cleared Aug 28, 2009
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
K091753 · GQL
Diagnostic Hybrids, Inc.
Microbiology · 73d
Cleared Aug 28, 2009
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
K091844 · MAI
Arthrex, Inc.
Orthopedic · 67d
Cleared Aug 28, 2009
CARESCAPE MONITOR B850
K092027 · MHX
Ge Medical Systems Information...
Cardiovascular · 53d
Cleared Aug 28, 2009
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
K092285 · IYE
Best Medical Canada , Ltd.
Radiology · 30d
Cleared Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 30d
Cleared Aug 28, 2009
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED...
K092458 · KXK
Isoray Medical, Inc.
Radiology · 17d
Cleared Aug 28, 2009
VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
K092486 · DWE
Vortex Medical, Inc.
Cardiovascular · 15d
Cleared Aug 27, 2009
MINISILK FT
K082040 · ONF
El.En Electronic Engineering Spa
General & Plastic Surgery · 405d
Cleared Aug 27, 2009
WMT COMPOSITE DBM
K083270 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 294d
Cleared Aug 27, 2009
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING...
K083867 · CDZ
Beckman Coulter, Inc.
Chemistry · 241d
Cleared Aug 27, 2009
INSPIRA HD, MODEL: NL1000
K090811 · KPS
Neurologica Corporation
Radiology · 155d
Cleared Aug 27, 2009
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL...
K090869 · DWF
Medtronic Perfusion Systems
Cardiovascular · 149d
Cleared Aug 27, 2009
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT)...
K091971 · DSI
Corventis, Inc.
Cardiovascular · 57d
Cleared Aug 27, 2009
FOX SV PTA CATHETER
K092286 · LIT
Abbott Vascular
Cardiovascular · 29d
Cleared Aug 27, 2009
SEGUIN ANNULOPLASTY RING
K092310 · KRH
St Jude Medical
Cardiovascular · 29d
Cleared Aug 27, 2009
MAMMOSITE MULTI LUMEN
K092405 · JAQ
Hologic, Inc.
Radiology · 21d
Cleared Aug 27, 2009
SYNGO.X
K092519 · LLZ
Siemens AG Medical Solutions
Radiology · 9d