FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77617–77640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233 · JIT
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 11, 2001
CLEARFIL PHOTO CORE
K012705 · EBF
Kuraray Medical, Inc.
Dental · 28d
Cleared Sep 10, 2001
AQUANET, MODEL EC 2000
K000031 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 614d
Cleared Sep 10, 2001
PALOMAR DERMALUX PULSED LIGHT SYSTEM
K010618 · GEX
Palomar
General & Plastic Surgery · 193d
Cleared Sep 10, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR...
K011044 · LYY
Shen Wei (Usa), Inc.
General Hospital · 158d
Cleared Sep 10, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K011841 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 90d
Cleared Sep 10, 2001
PRESSURE ACTIVATED CHECK VALVE
K011888 · FPA
Churchill Medical Systems, Inc.
General Hospital · 84d
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