FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78145–78168 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2001
IMAGER II ANGIOGRAPHIC CATHETER
K011664 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 100d
Cleared Sep 07, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K011806 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 07, 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · KRO
Depuy, Inc.
Orthopedic · 88d
Cleared Sep 07, 2001
MINI MULTILEAF COLLIMATOR, MODEL KMI
K011816 · IXI
Mrc Systems GmbH
Radiology · 88d
Cleared Sep 07, 2001
CYNOSURE ACCLAIM DERMATOLOGY LASER
K011828 · GEX
Cynosure, Inc.
General & Plastic Surgery · 87d
Cleared Sep 07, 2001
MPF ACETABULAR CUP
K011836 · LZO
Plus Orthopedics
Orthopedic · 87d
Cleared Sep 07, 2001
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY...
K012208 · DDC
Beckman Coulter, Inc.
Immunology · 53d
Cleared Sep 07, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY...
K012590 · FGE
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Sep 07, 2001
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
K012836 · JAK
GE Medical Systems
Radiology · 15d
Cleared Sep 06, 2001
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 400d
Cleared Sep 06, 2001
UROSCOPE, ARTES MEDICAL, USA
K003988 · FAJ
Artes Medical USA, Inc.
Gastroenterology & Urology · 254d
Cleared Sep 06, 2001
LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
K010431 · GXY
Lead-Lok, Inc.
Neurology · 205d
Cleared Sep 06, 2001
LIVER TAMPONADE BALLOON
K010450 · NGU
Cook, Inc.
General & Plastic Surgery · 203d
Cleared Sep 06, 2001
VECTORVISION KNEE
K010612 · HAW
Brainlab AG
Neurology · 189d
Cleared Sep 06, 2001
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS,...
K011128 · CIB
Nichols Institute Diagnostics
Chemistry · 146d
Cleared Sep 06, 2001
DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
K011361 · DRF
Catheffects, LLC
Cardiovascular · 126d
Cleared Sep 06, 2001
NEUROTHERM, MODEL JK4
K011387 · GXI
Eurolink, LLC
Neurology · 122d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · KTW
Synthes (Usa)
Orthopedic · 87d
Cleared Sep 06, 2001
STERILE EMG ELECTRODES
K011818 · IKT
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · HWC
New Deal, S.A.
Orthopedic · 87d
Cleared Sep 06, 2001
BIOREHAB SYSTEM
K011823 · HCC
Nicolet Biomedical, Inc.
Neurology · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE TAC' PIN
K011875 · JDW
New Deal, S.A.
Orthopedic · 83d
Cleared Sep 06, 2001
OPTIBOND SOLO PLUS 3
K011908 · EBC
Kerr Dental Materials Center
Dental · 79d
Cleared Sep 06, 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050 · DQY
Guidant Corp.
Cardiovascular · 66d