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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
67177–67200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2004
MIMIX MP BONE VOID FILLER
K043280 · GXP
Biomet, Inc.
Neurology · 25d
Cleared Dec 21, 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
K043291 · GEI
Medtronic Vascular
General & Plastic Surgery · 22d
Cleared Dec 21, 2004
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM
K043452 · IYN
Sonosite,Inc.
Radiology · 6d
Cleared Dec 21, 2004
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM
K043455 · IYN
Medison Co., Ltd.
Radiology · 6d
Cleared Dec 21, 2004
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · JOJ
STERIS Corporation
General Hospital · 4d
Cleared Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K041658 · LKJ
Bio-Rad Laboratories, Inc.
Immunology · 185d
Cleared Dec 20, 2004
OSS/(SCARF)- AND OSW-SCREW
K042079 · HWC
O.M.T. Oberflachen-Und...
Orthopedic · 140d
Cleared Dec 20, 2004
SYSTEMP.LINK
K042846 · EMA
Ivoclar Vivadent, Inc.
Dental · 66d
Cleared Dec 20, 2004
MODIFICATION TO: PNEUTON VENTILATOR
K043085 · CBK
Airon Corporation
Anesthesiology · 42d
Cleared Dec 20, 2004
POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE,...
K043159 · LYZ
Shijaizhuang Brilliant Ocean Plastic...
General Hospital · 35d
Cleared Dec 20, 2004
WILLI GELLER CREATION CP PORCELAIN
K043221 · EIH
Jensen Industries, Inc.
Dental · 28d
Cleared Dec 20, 2004
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
K043244 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 27d
Cleared Dec 20, 2004
MODIFICATION TO: VIEWSTATION
K043412 · LLZ
Impac Medical Systems, Inc.
Radiology · 10d
Cleared Dec 17, 2004
POLYGRAFT BGS
K040047 · MQV
Osteobiologics, Inc.
Orthopedic · 340d
Cleared Dec 17, 2004
THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
K040049 · NZA
STERIS Corporation
General Hospital · 340d
Cleared Dec 17, 2004
TRANS1 AXIAL FIXATION SYSTEM
K040426 · KWQ
Trans1, Inc.
Orthopedic · 302d
Cleared Dec 17, 2004
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592 · DQX
Cordis Corp.
Cardiovascular · 284d
Cleared Dec 17, 2004
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
K041619 · MMI
Biocheck, Inc.
Chemistry · 185d
Cleared Dec 17, 2004
CORTRAK
K041987 · KNT
Viasys Medsystems
Gastroenterology & Urology · 147d
Cleared Dec 17, 2004
INFINITY ELECTROTHERAPY SYSTEM
K042057 · LIH
Empi
Neurology · 140d
Cleared Dec 17, 2004
KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT
K042248 · NST
Kronus Market Development Associates,...
Immunology · 120d
Cleared Dec 17, 2004
TORAYGUIDE GUIDEWIRE
K042370 · DQX
Toray Industries (America), Inc.
Cardiovascular · 108d
Cleared Dec 17, 2004
DOC BAND-POSTOP
K042385 · MVA
Cranial Technologies, Inc.
Neurology · 107d
Cleared Dec 17, 2004
MODIFICATION TO SHORT INTRODUCER SHEATH
K042399 · DYB
Rex Medical, L.P.
Cardiovascular · 105d