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

Filters: Cleared only ×
176,076 results
78745–78768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2001
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · FLL
Avita Corporation
General Hospital · 63d
Cleared Sep 10, 2001
CG-2211 SELFCHECK ECG TRANSMITTER
K012223 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d
Cleared Sep 10, 2001
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800,...
K012229 · FMT
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 10, 2001
MODIFICATION TO CLEARFIL SE BOND
K012442 · KLE
Kuraray Medical, Inc.
Dental · 41d
Cleared Sep 10, 2001
CLEARFIL CORE NEW BOND
K012703 · EBF
Kuraray Medical, Inc.
Dental · 27d
Cleared Sep 10, 2001
CLEARFIL ST OPAQUER
K012704 · EBF
Kuraray Medical, Inc.
Dental · 27d
Cleared Sep 10, 2001
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · LJS
C.R. Bard, Inc.
General Hospital · 12d
Cleared Sep 07, 2001
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
K010750 · GGN
Fisher Diagnostics
Hematology · 178d
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