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
170881–170904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1978
ANTITHROMBIN III SERUM, ANTI-HUMAN
K781026 · JBQ
Icl Scientific
Immunology · 52d
Cleared Aug 10, 1978
AUTO-SYRINGE INFUSION SET
K781036 · FPA
Baxter Healthcare Corp
General Hospital · 52d
Cleared Aug 10, 1978
SECOND ANTIBODY
K781070 · KTS
Pcl-Ria, Inc.
Immunology · 45d
Cleared Aug 10, 1978
TRAP-BLOOD VESSEL STABILIZATION DEVICE
K781072 · JIT
Ayer, Patrick, M.D.
Chemistry · 45d
Cleared Aug 10, 1978
PLASMA COAGULATION CONT., ABNORMAL
K781104 · GFO
Ortho Diagnostics, Inc.
Hematology · 38d
Cleared Aug 10, 1978
THERMOMETER, EXACTA TEMP
K781106 · FLK
S.M.B. Celsius Co., Inc.
General Hospital · 38d
Cleared Aug 10, 1978
ECA BUFFER, PH 816
K781116 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
ECA PREP
K781117 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
ECA BUFFER PH 8.8
K781118 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
TRICHLORACETIC ACID 7.5%
K781120 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
PONCEAU S
K781123 · CEF
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
CPK ISOENZYME REAGENT
K781124 · JHW
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
LDH ISOENZYME REAGENT
K781125 · CFE
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Aug 10, 1978
LDH (UV KINETIC)
K781128 · CFJ
Macomb Chemical Co.
Chemistry · 41d
Cleared Aug 10, 1978
CHEMLAR
K781132 · JFS
Hi Chem, Inc.
Chemistry · 38d
Cleared Aug 10, 1978
TEMPERATURE MODULE, DUAL
K781136 · FLL
Cavitron Corp.
General Hospital · 34d
Cleared Aug 10, 1978
SYRINGE, INSULIN, HYPOTIP
K781154 · FMF
National Patent Development Corp.
General Hospital · 31d
Cleared Aug 10, 1978
INFUSION PUMP, PEDIATRIC MODEL 301
K781171 · FRN
Imed Corp.
General Hospital · 28d
Cleared Aug 10, 1978
INFUSION SET, VENOTHIN 19
K781184 · FPA
Venospital, Inc.
General Hospital · 27d
Cleared Aug 10, 1978
INFUSION SET W/ INJECTION SITE
K781185 · FPA
Venospital, Inc.
General Hospital · 27d
Cleared Aug 10, 1978
INFUSION, VENOTHIN 23
K781186 · FPA
Venospital, Inc.
General Hospital · 27d
Cleared Aug 10, 1978
INFUSION SET W/ INJECTION SITE, 23D-W
K781187 · FPA
Venospital, Inc.
General Hospital · 27d
Cleared Aug 10, 1978
INFUSION SET, VENOTHIN 25
K781188 · FPA
Venospital, Inc.
General Hospital · 27d
Cleared Aug 10, 1978
FLU VEN 0151
K781189 · FPA
Venospital, Inc.
General Hospital · 27d