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
54817–54840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2008
A-DEC 334/335 DELIVERY SYSTEM
K082985 · EIA
A-Dec, Inc.
Dental · 71d
Cleared Dec 17, 2008
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392 · LZO
Exactech, Inc.
Orthopedic · 30d
Cleared Dec 17, 2008
PHILIPS MODEL MX 16 SLICE CT SYSTEM
K083498 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 22d
Cleared Dec 17, 2008
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
K083610 · EBF
3M Company
Dental · 9d
Cleared Dec 16, 2008
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
K080741 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 274d
Cleared Dec 16, 2008
VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
K081929 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 162d
Cleared Dec 16, 2008
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
K082210 · CIG
Genzyme Diagnostics P.E.I., Inc.
Chemistry · 132d
Cleared Dec 16, 2008
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
K082278 · NEU
Ethicon Endo-Sugery, LLC
General & Plastic Surgery · 127d
Cleared Dec 16, 2008
UNITED U2 TOTAL KNEE SYSTEM
K082424 · JWH
United Orthopedic Corp.
Orthopedic · 116d
Cleared Dec 16, 2008
STRYKER VIDEOSCOPE
K082451 · HET
Stryker Endoscopy
Obstetrics & Gynecology · 113d
Cleared Dec 16, 2008
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
K082724 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 90d
Cleared Dec 16, 2008
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
K083063 · OLW
Mennen Medical , Ltd.
Neurology · 63d
Cleared Dec 16, 2008
TOGGLELOC SYSTEM
K083070 · MBI
Biomet Sports Medicine
Orthopedic · 62d
Cleared Dec 16, 2008
NEURO III-SV
K083137 · LNH
Imris, Inc.
Radiology · 54d
Cleared Dec 16, 2008
SYSTEM-ARMS, MODELS 390, X60
K083164 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 50d
Cleared Dec 16, 2008
INTROL CF PANEL I CONTROL, MODEL: G106
K083171 · NZB
Maine Molecular Quality Controls, Inc.
Pathology · 50d
Cleared Dec 16, 2008
SKINCLEAR Q-SWITCHED ND:YAG LASER
K083272 · GEX
Global USA Distribution, LLC
General & Plastic Surgery · 40d
Cleared Dec 16, 2008
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
K083538 · OBP
Neuronetics
Neurology · 18d
Cleared Dec 16, 2008
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
K083555 · LLZ
Emsoma Co., Ltd.
Radiology · 14d
Cleared Dec 15, 2008
EMBOZENE MICROSPHERES
K073417 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 377d
Cleared Dec 15, 2008
DISTRAX
K080542 · MQN
John W. King
Dental · 292d
Cleared Dec 15, 2008
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
K082224 · ITX
Shimadzu Medical Systems
Radiology · 131d
Cleared Dec 15, 2008
VISIONSENSE STEREOSCOPIC VISION SYSTEM
K082355 · HRX
Visionsense, Ltd.
Orthopedic · 122d
Cleared Dec 15, 2008
CENEFOM PVA SURGICAL SPEAR
K082460 · HOZ
Longtek Scientific Co., Ltd.
Ophthalmic · 111d