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
50665–50688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2010
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
K100745 · DRT
Hoana Medical, Inc.
Cardiovascular · 30d
Cleared Apr 14, 2010
BINAXNOW PBP2A TEST, MODEL 890-000
K090301 · MYI
Binax, Inc.
Microbiology · 432d
Cleared Apr 14, 2010
SYNTHES AIR PEN DRIVE (APD) SYSTEM
K093361 · HBB
Synthes (Usa)
Neurology · 168d
Cleared Apr 14, 2010
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
K093746 · JWH
Smith & Nephew, Inc.
Orthopedic · 131d
Cleared Apr 14, 2010
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
K093904 · KNA
Glenveigh Surgical, LLC
Obstetrics & Gynecology · 113d
Cleared Apr 14, 2010
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
K093907 · DXN
Welch Allyn, Inc.
Cardiovascular · 113d
Cleared Apr 14, 2010
HYBERNITE RAINOUT CONTROL SYSTEM
K100104 · BZE
Plastiflex Group NV
Anesthesiology · 91d
Cleared Apr 14, 2010
AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
K100108 · NGL
Amedica Biotech, Inc.
Chemistry · 90d
Cleared Apr 14, 2010
INTELLIVUE CLINICAL INFORMATION PORTFOLIO
K100272 · DXJ
Philips Medical Systems
Cardiovascular · 75d
Cleared Apr 14, 2010
CAMBRIDGE HEART OEM
K100362 · DQK
Cambridge Heart, Inc.
Cardiovascular · 61d
Cleared Apr 14, 2010
CONTREX PLUS LOW CONTROL SOLUTION
K100747 · JJX
Apex BioTechnology Corp.
Chemistry · 29d
Cleared Apr 14, 2010
SYNAPSE OBLIQUUS MIP/MPR/FUSION
K100881 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Apr 13, 2010
ZUMA-C
K092521 · OVE
Seaspine, Inc.
Orthopedic · 238d
Cleared Apr 13, 2010
RETROFLEX DILATOR KIT
K093554 · DRE
Edwards Lifesciences, LLC
Cardiovascular · 147d
Cleared Apr 13, 2010
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
K093695 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 134d
Cleared Apr 13, 2010
VASHE WOUND THERAPY SOLUTION
K093697 · FRO
Puricore, Inc.
General & Plastic Surgery · 134d
Cleared Apr 13, 2010
A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07,...
K100145 · EIH
A&E Bioceramic Co., Ltd.
Dental · 84d
Cleared Apr 13, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100392 · LYZ
Tangshan Jiaxing Plastic Products...
General Hospital · 56d
Cleared Apr 12, 2010
DEROYAL NON-LOCKING BONE FIXATION SYSTEM
K090975 · HRS
Deroyal Industries, Inc.
Orthopedic · 371d
Cleared Apr 12, 2010
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
K091022 · MED
STERIS Corporation
General Hospital · 368d
Cleared Apr 12, 2010
PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER...
K092066 · QPB
Andrew Technologies, LLC
General & Plastic Surgery · 278d
Cleared Apr 12, 2010
ENTEROSCOPY OVERTUBE, MODEL 00712140
K100081 · FED
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 12, 2010
MULTI FRAME WHEELCHAIR
K100084 · IOR
R82 A/S
Physical Medicine · 90d
Cleared Apr 12, 2010
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K100111 · HRS
Zimmer, Inc.
Orthopedic · 88d