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
167809–167832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1979
ELVI TRIGLYCERIDE
K792414 · JGY
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792415 · CIG
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI TOTAL PROTEINS
K792416 · CER
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI BLOOD UREA NITROGEN
K792417 · CDL
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
HIM TEST COCAINE
K792429 · DLN
Tecknam, Inc.
Toxicology · 9d
Cleared Dec 06, 1979
PERITONEAL DIALYSIS CYCLER MODEL PDC1000
K791676 · KPF
J.M. Sounds Electronics Co.
Gastroenterology & Urology · 101d
Cleared Dec 06, 1979
FERRITIN RIA KIT
K791860 · DBF
Cis Radiopharmaceuticals, Inc.
Immunology · 78d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053 · FJK
Erika, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054 · FJK
Erika, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 06, 1979
BROWNE MODEL UD-4
K792090 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UD-4D
K792091 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UD-4E
K792092 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL GD-5
K792093 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
BROWNE MODEL UA-6
K792094 · FAP
Browne Corp.
Gastroenterology & Urology · 50d
Cleared Dec 06, 1979
ARM SHIELD FOR ANESTHESIA
K792147 · BTX
Medical Innovations Corp.
General & Plastic Surgery · 45d
Cleared Dec 06, 1979
MODEL 808 ADAPTER
K792150 · GEI
Malibu Laboratories
General & Plastic Surgery · 45d
Cleared Dec 06, 1979
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
K792179 · FDF
American Optical Corp.
Gastroenterology & Urology · 38d
Cleared Dec 06, 1979
HUMAN CHORIONIC GONADOTROPIN (RIA)
K792197 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 35d
Cleared Dec 06, 1979
SEIDEL INTRAMEDULLARY PLUG
K792205 · HWC
Howmedica Corp.
Orthopedic · 34d
Cleared Dec 06, 1979
VANCE MALLEABLE TIP FILIFORM
K792219 · KOE
Vance Products, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
VANCE KIDNEY BIOPSY BRUSHES
K792220 · KOD
Vance Products, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
VANCE PHILIPS FOLLOWER CATHETER & BOUGIE
K792221 · KOE
Vance Products, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
CENTRIA CORTISOL RIA TEST SET
K792243 · CGR
Ventrex Laboratories, Inc.
Chemistry · 29d
Cleared Dec 06, 1979
NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE
K792254 · JFL
Nova Biomedical Corp.
Chemistry · 28d