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
78529–78552 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2001
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K011792 · LZA
Latexx Partners Bhd.
General Hospital · 54d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K012056 · FGE
Cordis Europa, N.V.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
8100/8500 VITAL SIGNS MONITOR
K012059 · MWI
Criticare Systems, Inc.
Cardiovascular · 30d
Cleared Aug 01, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012066 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
K012069 · JXE
Neurotron Medical, Inc.
Neurology · 30d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012090 · FGE
Cordis, A Johnson & Johnson Co.
Gastroenterology & Urology · 27d
Cleared Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128 · FOZ
Ethicon Endo-Surgery, Inc.
General Hospital · 23d
Cleared Aug 01, 2001
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K012135 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 23d
Cleared Aug 01, 2001
MODIFICATION TO: LONG LENGTH GAMMA NAIL
K012158 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Aug 01, 2001
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
K012166 · LZA
Best Manufacturing Company
General Hospital · 21d
Cleared Aug 01, 2001
MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
K012167 · IOR
Invacare Corp.
Physical Medicine · 20d
Cleared Aug 01, 2001
M5T INSTANT FEVER THERMOMETER
K012217 · FLL
Medisim, Ltd.
General Hospital · 16d
Cleared Aug 01, 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 14d
Cleared Aug 01, 2001
TRS-2000 POWER TILT/POWER RECLINE SYSTEM
K012281 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 12d
Cleared Aug 01, 2001
MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
K012299 · DZE
Basic Dental Implant Systems, Inc.
Dental · 12d
Cleared Jul 31, 2001
COPAN VIRAL TRANSYSTEM
K001780 · JSM
Copan Diagnostics, Inc.
Microbiology · 413d
Cleared Jul 31, 2001
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
K003285 · IYE
Brainlab AG
Radiology · 285d
Cleared Jul 31, 2001
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
K003580 · FFX
Unisensor AG
Gastroenterology & Urology · 253d
Cleared Jul 31, 2001
R STENT BILIARY ENDOPROSTHESIS
K010107 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 200d
Cleared Jul 31, 2001
SUREVUE URINE HCG
K010522 · JHI
Sa Scientific, Inc.
Toxicology · 159d
Cleared Jul 31, 2001
PREVISION CHEM
K010541 · EMA
Heraeus Kulzer, Inc.
Dental · 158d
Cleared Jul 31, 2001
METHADONE MICROPLATE EIA URINE APPLICATION
K011131 · DJR
Cozart Bioscience , Ltd.
Toxicology · 109d
Cleared Jul 31, 2001
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K011354 · HRS
Dj Orthopedics, LLC
Orthopedic · 89d