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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
151465–151488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633 · JHI
Hybritech, Inc.
Chemistry · 45d
Cleared Aug 23, 1984
SERIMM SURE ASO-CHEK CONTROL SERUM
K842839 · GTQ
Analytical Products, Inc.
Immunology · 34d
Cleared Aug 23, 1984
SUPER MAXITHINS BODY-SHAPED MAXI PADS
K842950 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 28d
Cleared Aug 23, 1984
MAXITHINS BODY-SHAPED PANTY SHIELDS
K842951 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 28d
Cleared Aug 23, 1984
TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO
K843262 · JOP
Hewlett-Packard Co.
Cardiovascular · 3d
Cleared Aug 22, 1984
ULTRA SHAPE CONDOMS
K833365 · HIS
Barnetts, Inc.
Obstetrics & Gynecology · 330d
Cleared Aug 22, 1984
NOVA 12 CARDIAC OUTPUT COMPUTER
K840009 · DXG
Nova Medical Specialties
Cardiovascular · 231d
Cleared Aug 22, 1984
DYNASCOPE SERIES
K840055 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 229d
Cleared Aug 22, 1984
BETA-HCG HEMAGGLUTINATION TEST
K842181 · JHJ
Sero-Immuno Diagnostics, Inc.
Chemistry · 82d
Cleared Aug 22, 1984
ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT
K842752 · JXR
The Perkin-Elmer Corp.
Toxicology · 37d
Cleared Aug 22, 1984
QCA TRIGLYCERIDES
K842891 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 30d
Cleared Aug 22, 1984
REGULAR MAXITHINS BODY-SHAPED MAXI
K842952 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 22, 1984
COMPANION 492 OXYGEN CONCENTRATOR
K843243 · CAW
Puritan Bennett Corp.
Anesthesiology · 368d
Cleared Aug 21, 1984
MICRO DELTA & CELTAPRO
K841964 · IYX
Computer Design & Applications, Inc.
Radiology · 99d
Cleared Aug 21, 1984
ADP NDNA IFA TEST
K842707 · KTL
Apple Diagnostic Products
Immunology · 40d
Cleared Aug 21, 1984
INTERFERENZ 4
K842803 · IPF
Robert Bosch Corp.
Physical Medicine · 35d
Cleared Aug 21, 1984
DIADYN 4
K842804 · IPF
Robert Bosch Corp.
Physical Medicine · 35d
Cleared Aug 21, 1984
PRO-PAR CLEARANT
K842861 · KEM
Anatech, Ltd.
Pathology · 29d
Cleared Aug 21, 1984
PRO-SOFT DEHYDRANT
K842863 · PPM
Anatech, Ltd.
Pathology · 29d
Cleared Aug 21, 1984
SEP PROGRAMMER FOR PUCK U & UD FILMCHANG
K842903 · IZP
Elema-Schonander, Inc.
Radiology · 28d
Cleared Aug 21, 1984
PUCK U & UD CUTFILM CHANGERS
K842911 · KPX
Elema-Schonander, Inc.
Radiology · 29d
Cleared Aug 21, 1984
ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL
K842953 · HRR
All-Hands Medical Supply, Inc.
Orthopedic · 25d
Cleared Aug 21, 1984
REFRAX MOUNTING MEDIUM
K842986 · LEB
Anatech, Ltd.
Pathology · 22d
Cleared Aug 20, 1984
MICROSURGICAL CO2 LASER SYS - 4100
K840406 · GEX
Bio Quantum Technologies, Inc.
General & Plastic Surgery · 202d