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
78025–78048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 31, 2001
RESORBABLE BONE PINS
K011522 · HTY
Biomet, Inc.
Orthopedic · 75d
Cleared Jul 31, 2001
QCU ANALYTICAL SOFTWARE PACKAGE
K011582 · LLZ
Medis Medical Imaging Systems BV
Radiology · 69d
Cleared Jul 31, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
K011658 · JIX
Rochdiag
Chemistry · 63d
Cleared Jul 31, 2001
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP...
K011672 · LAF
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 31, 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST...
K011673 · DKZ
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 31, 2001
BISTITE II DC
K011685 · EMA
Tokuyama America, Inc.
Dental · 61d
Cleared Jul 31, 2001
ZOLL M SERIES IBP OPERATION
K011865 · DSK
Zoll Medical Corp
Cardiovascular · 47d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900 · CFR
Jas Diagnostics, Inc.
Chemistry · 43d