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
35785–35808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2015
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
K143005 · PCH
Biofire Diagnostics, LLC
Microbiology · 122d
Cleared Feb 19, 2015
LYNC intramedullary implant
K143049 · HTY
Novastep
Orthopedic · 119d
Cleared Feb 19, 2015
Codman Certas Plus Programmable Valve
K143111 · JXG
Medos International SARL
Neurology · 113d
Cleared Feb 19, 2015
Sensititre Susceptibility Plates
K143381 · JWY
Thermo Fisher Scientific
Microbiology · 86d
Cleared Feb 19, 2015
NeuroBlate System
K143457 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 78d
Cleared Feb 19, 2015
Checkpoint, Checkpoint Head & Neck
K150005 · ETN
Ndi Medical, LLC
Ear, Nose, Throat · 48d
Cleared Feb 19, 2015
GM60A-32S & GM60A-40S
K150097 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Feb 19, 2015
Lubrigyn cream
K150147 · NUC
Uniderm Farmaceutici Srl
Obstetrics & Gynecology · 28d
Cleared Feb 18, 2015
BODY COMPOSITION ANALYZER
K140045 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 406d
Cleared Feb 18, 2015
SATURN 5 LASER
K141434 · MRX
Research Instruments , Ltd.
Obstetrics & Gynecology · 264d
Cleared Feb 18, 2015
E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL
K141587 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 250d
Cleared Feb 18, 2015
Polysmith Sleep System
K142774 · OLV
Neurotronics, Inc.
Neurology · 145d
Cleared Feb 18, 2015
Optima XR646
K143270 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 97d
Cleared Feb 18, 2015
Medtronic Model 5392 External Pulse Generator (EPG)
K150246 · DTE
Medtronic, Inc.
Cardiovascular · 16d
Cleared Feb 17, 2015
NUROS BONE GRAFT SUBSTITUTE
K140913 · MQV
Oriental Resources Development Limited
Orthopedic · 313d
Cleared Feb 17, 2015
MEDEOR MATRIX WOUND DRESSING
K141738 · KGN
Kensey Nash Corporation Dba Dsm...
General & Plastic Surgery · 235d
Cleared Feb 17, 2015
Master Caution Device MCD
K142476 · DXH
Healthwatch , Ltd.
Cardiovascular · 167d
Cleared Feb 17, 2015
LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization...
K142991 · MQL
Life Global Group, LLC
Obstetrics & Gynecology · 124d
Cleared Feb 17, 2015
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
K143080 · OCC
Biofire Diagnostics, LLC
Microbiology · 113d
Cleared Feb 17, 2015
Maxima XTEND Handpiece Maintenance System
K143183 · EFB
Handpiece Headquarters
Dental · 104d
Cleared Feb 17, 2015
CONELOG Titanium base CAD/CAM
K143337 · NHA
Altatec GmbH
Dental · 89d
Cleared Feb 17, 2015
Klassic Knee System-Sombrero Patella
K150105 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 28d
Cleared Feb 13, 2015
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
K140881 · MBH
Depuy(Ireland)
Orthopedic · 312d
Cleared Feb 13, 2015
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID...
K141205 · DJG
Lin-Zhi International, Inc.
Toxicology · 280d