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
153097–153120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1984
MMG FOLEY CATHETER
K840839 · KOD
Medical Technologies of Georgia
Gastroenterology & Urology · 53d
Cleared Apr 17, 1984
POTASSIUM CHLORIDE TABLETS
K840843 · CHL
Bionostics, Inc.
Chemistry · 53d
Cleared Apr 17, 1984
PHADEBAS RAST TEST -ALLERGEN DISCS
K840876 · DHB
Pharmacia, Inc.
Toxicology · 50d
Cleared Apr 17, 1984
ARGYLE TAPERED VASCULAR SHUNT
K840914 · DWF
Sherwood Medical Co.
Cardiovascular · 48d
Cleared Apr 17, 1984
DIMIX CONTAINER FOR PARNETERAL NUTRIT
K840915 · KPE
Gil-Med Industries C/O Kegan & Kegan,...
General Hospital · 48d
Cleared Apr 17, 1984
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT
K840918 · KLK
Biochem International, Inc.
Anesthesiology · 47d
Cleared Apr 17, 1984
DAYPAK SYS VII CATHETER CARE KIT
K840919 · KLK
Creative Care Systems, Inc.
Anesthesiology · 47d
Cleared Apr 17, 1984
ANGIOGRAPHY NEEDLE W/WO CONNECTION
K840923 · DYB
Dlp, Inc.
Cardiovascular · 46d
Cleared Apr 17, 1984
DESERET LONG TERM INDWELLING CATHETER
K840958 · LJS
Parke-Davis Co.
General Hospital · 42d
Cleared Apr 17, 1984
BATTERY POWERED PATIENT LIFT
K840997 · FSA
Invacare Corp.
General Hospital · 40d
Cleared Apr 17, 1984
HOLDER FOR MODELS AF-10,1025,1040,5
K841032 · KRI
American Bentley
Cardiovascular · 36d
Cleared Apr 17, 1984
PRESSURE MANOMETER
K841071 · DQX
Interventional Medical, Inc.
Cardiovascular · 36d
Cleared Apr 17, 1984
WILLIAM HARVEY H-4700 FILTER/CARDIO
K841079 · DTN
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Apr 17, 1984
DRESSING CHANGE TRAY
K841123 · FRG
Medcare Products
General Hospital · 33d
Cleared Apr 17, 1984
MINI PECG-MODIFICATION
K841148 · DPS
Intersect Systems, Inc.
Cardiovascular · 27d
Cleared Apr 17, 1984
MULTIPLE BIOCHEMICAL TEST
K841204 · JSE
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & DIFFERENTIAL
K841206 · JSH
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & NON-DIFFERENTIAL
K841207 · JSI
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
SELECTIVE AND DIFFERENTIAL
K841209 · JSI
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
CAMPYLOBACTER THIOGLYCOLLATE MED
K841303 · JSG
Anaerobe Systems
Microbiology · 18d
Cleared Apr 17, 1984
HAEMOPHILUS ID QUAD-PLATE
K841304 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 18d
Cleared Apr 17, 1984
MOUTH TO MASK EMERGENCY VENTILATION
K841429 · CAE
O-Two Systems Intl., Inc.
Anesthesiology · 11d
Cleared Apr 16, 1984
OBSTETRIC PULSAR TWO CHANNEL TENS
K840497 · GZJ
Spembly Medical , Ltd.
Neurology · 70d
Cleared Apr 16, 1984
DAYPAK SYSTEM III CATHETER CARE KIT
K840681 · LJS
Creative Care Systems, Inc.
General Hospital · 61d