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
155761–155784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1983
VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE
K831971 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 73d
Cleared Sep 01, 1983
STERILE DISPOSABLE NEEDLES
K832102 · FMI
Lee Medical Intl., Inc.
General Hospital · 70d
Cleared Sep 01, 1983
PHADEBACT STREP POSITIVE CONTROLS
K832248 · GTY
Pharmacia, Inc.
Hematology · 52d
Cleared Sep 01, 1983
HEMOGLOBINOMETER
K832288 · KMG
Mallinckrodt Critical Care
Hematology · 50d
Cleared Sep 01, 1983
SOLO-TACH
K832292 · DYH
Dentsply Intl.
Dental · 50d
Cleared Sep 01, 1983
HYDROXYPROGESTERONE-17
K832297 · JLS
Diagnostics Biochem Canada, Inc.
Chemistry · 50d
Cleared Sep 01, 1983
ROGOSA BROTH
K832310 · JSD
Oxoid U.S.A., Inc.
Microbiology · 49d
Cleared Sep 01, 1983
MAGIC TSH 125I RADIOIMMUNOASSAY
K832313 · JLW
Corning Medical & Scientific
Chemistry · 49d
Cleared Sep 01, 1983
CARDIZYME PLUS LD #65094/93
K832314 · CFE
Em Industries, Inc.
Chemistry · 49d
Cleared Sep 01, 1983
FEEDBACK EMG SYSTEM PE-020
K832333 · HCC
Bio-Feedback Systems, Inc.
Neurology · 45d
Cleared Sep 01, 1983
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK
K832357 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 45d
Cleared Sep 01, 1983
TCBS AGAR
K832365 · JSI
Granite Diagnostics, Inc.
Microbiology · 45d
Cleared Sep 01, 1983
CORNING MAGIC SINGLE STEP FREE T4
K832381 · CEC
Corning Medical & Scientific
Chemistry · 44d
Cleared Sep 01, 1983
A-GENT PHERYTOIN
K832419 · DIP
Abbott Laboratories
Toxicology · 41d
Cleared Sep 01, 1983
FACS ANALYZER
K832420 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 41d
Cleared Sep 01, 1983
OHIO 5400 VOLUME MONITOR
K832565 · BZK
Airco/Ohio Medical Products
Anesthesiology · 30d
Cleared Aug 31, 1983
HANCOCK PERICARDIAL PATCH
K830863 · DXZ
Extracorporeal Medical Specialities,...
Cardiovascular · 166d
Cleared Aug 31, 1983
ROYALE II
K831095 · EBI
Factor, Ii, Inc.
Dental · 149d
Cleared Aug 31, 1983
SOLARCRY/TEMPORARY CROWN & BRIDGE MAT
K831294 · EBG
Solar Dental Co., Inc.
Dental · 133d
Cleared Aug 31, 1983
RAPID ATRIAL PACER
K831381 · DTE
Seamed Corp.
Cardiovascular · 125d
Cleared Aug 31, 1983
COLLINS DS
K831777 · BZC
Warren E. Collins, Inc.
Anesthesiology · 90d
Cleared Aug 31, 1983
RS-RESIDUAL VOLUME SYSTEM
K831778 · BZC
Warren E. Collins, Inc.
Anesthesiology · 90d
Cleared Aug 31, 1983
JEJUNOSTOMY KIT
K831847 · KNT
Accu-Line
Gastroenterology & Urology · 84d
Cleared Aug 31, 1983
LEADING EDGE OPHTHALMIC KNIFE
K831975 · HNN
Surgidev Corp.
Ophthalmic · 72d