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
160417–160440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1982
ANTIHUMAN IGG GLOBULIN FITC LABELED
K821018 · DEW
Microbiological Research Corp.
Immunology · 17d
Cleared Apr 29, 1982
ARTHROSCOPY SYSTEM LEG HOLDER
K821029 · FWZ
Zimmer, Inc.
General & Plastic Surgery · 16d
Cleared Apr 29, 1982
COMPRES PORTABLE HEAT PADS
K821046 · IMD
S.C. Johnson & Son, Inc.
Physical Medicine · 15d
Cleared Apr 29, 1982
PARATHERM
K821049 · KYA
American Thermometer Company, Inc.
Radiology · 23d
Cleared Apr 29, 1982
HEMATOXYLIN SOLUTION
K821062 · HYJ
Sigma Chemical Co.
Pathology · 14d
Cleared Apr 29, 1982
CONTOUR II LINK SP TOTAL HIP PROSTHESIS
K821066 · JDI
C.R. Bard, Inc.
Orthopedic · 14d
Cleared Apr 29, 1982
VIVONEX ACUTROL ENTERNAL FEEDING SYS
K821067 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 13d
Cleared Apr 28, 1982
VHR VIDEO SYSTEM
K827345
General Electric Co.
Radiology · 13d
Cleared Apr 27, 1982
AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
K820396 · GKT
Pheragen Technology Corp.
Hematology · 75d
Cleared Apr 27, 1982
ULTRASONIC TOOTHBRUSH
K820537 · JEQ
Ultrasonic Plaque Control Laboratories
Dental · 56d
Cleared Apr 26, 1982
RESPIRATOR MONITOR
K820720 · CAP
Rv Systems
Anesthesiology · 41d
Cleared Apr 26, 1982
OTE BIOMEDICAL #1296 - 16 CHAN. RECORD
K820779 · GWQ
Del Mar Avionics
Neurology · 34d
Cleared Apr 26, 1982
ALUMINA SILICA-ACTIVATED PARTIAL THROM
K820835 · GFO
Hyland Therapeutic Div., Travenol...
Hematology · 31d
Cleared Apr 26, 1982
URETERAL CATHETER CONNECTING TUBE
K820866 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 26, 1982
URETERAL CATHETER CONNECTOR
K820868 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 26, 1982
URETERAL STANT SET
K820870 · FAD
Van-Tec, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 26, 1982
EMIT URINE METHADONE ASSAY #3E319
K820900 · DDE
Syva Co.
Chemistry · 26d
Cleared Apr 26, 1982
MULTIPERFECTEMP
K820902 · GEI
Kay Medical, Inc.
General & Plastic Surgery · 26d
Cleared Apr 26, 1982
ACKRAD FLUID CONNECTING SET
K820937 · LHI
Ackrad Laboratories
General Hospital · 21d
Cleared Apr 26, 1982
NOVA III FLUIDS PACK
K820947 · JIX
Shaban Mfg. Co.
Chemistry · 20d
Cleared Apr 26, 1982
TOTAL CHOLESTEROL REAGENT SET
K820950 · CHH
Sterling Biochemical, Inc.
Chemistry · 20d
Cleared Apr 26, 1982
ENZYMATIC CHOLESTEROL KIT
K820951 · CHH
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Apr 26, 1982
BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS
K820967 · GEN
Mill-Rose Laboratory
General & Plastic Surgery · 20d
Cleared Apr 26, 1982
RETRIEVAL FORCEPS W/ALLIGATOR JAWS
K820968 · GEN
Mill-Rose Laboratory
General & Plastic Surgery · 20d