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
163945–163968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1981
RPR CARD TEST SYSTEM
K810658 · GMQ
Beckman Instruments, Inc.
Immunology · 20d
Cleared Mar 31, 1981
AUTODILUTER III
K810659 · JTC
Dynatech Corp.
Toxicology · 20d
Cleared Mar 31, 1981
LEECO LH-QUANT DIAGNOSTIC KIT
K810662 · CEP
Leeco Diagnostics, Inc.
Chemistry · 20d
Cleared Mar 31, 1981
ISOLATOR SYSTEM
K810664 · JKA
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 20d
Cleared Mar 31, 1981
AMERLEX ESTRIOL RIA KIT
K810667 · CGI
Amersham Corp.
Chemistry · 19d
Cleared Mar 31, 1981
PANTRAK E.K.
K810669 · CIW
Calbiochem-Behring Corp.
Chemistry · 19d
Cleared Mar 31, 1981
ENZYMATIC CHOLESTEROL
K810673 · CHH
Pointe Scientific, Inc.,
Chemistry · 19d
Cleared Mar 31, 1981
GLUCOSE OXIDASE
K810674 · CGA
Pointe Scientific, Inc.,
Toxicology · 19d
Cleared Mar 31, 1981
ENZYMATIC TRIGLYCERIDE
K810680 · CDT
Pointe Scientific, Inc.,
Chemistry · 18d
Cleared Mar 31, 1981
ESTRIOL RADIOIMMUNOASSAY TEST KIT
K810695 · CHP
Serono Laboratories, Inc.
Chemistry · 15d
Cleared Mar 31, 1981
COAT-A-COUNT T3 UPTAKE KIT
K810717 · KHQ
Diagnostic Products Corp.
Chemistry · 14d
Cleared Mar 31, 1981
C-PEPTICE REAGENTS
K810718 · JKD
Calbiochem-Behring Corp.
Chemistry · 14d
Cleared Mar 31, 1981
CORNING 178 BLOOD GAS ANALYZER
K810724 · CHL
Corning Medical & Scientific
Chemistry · 14d
Cleared Mar 31, 1981
QUALITROL #65057
K810725 · JJT
Harleco
Immunology · 14d
Cleared Mar 31, 1981
AST-UV (PLP-ACTIVATED) DETERMINATION
K810727 · CIT
The Dow Chemical Co.
Chemistry · 14d
Cleared Mar 31, 1981
LUMINESCENCE PHOTOMETER 100 SERIES
K810736 · JJQ
Sai Technology
Chemistry · 13d
Cleared Mar 31, 1981
GOODE MAGNETIC NASAL SPLINT
K810738 · EPP
Xomed, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 31, 1981
LUTEINIZING HORMONE
K810741 · CEP
Pcl-Ria, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
AQUEOUS TRIOLEIN STANDARDS & KITS
K810742 · JIS
Supelco, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
LECITHIN-SPINGOMYELIN STAND. & KITS
K810743 · JIS
Supelco, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
DOUBLE LUMEN SUBCLAVIN CATHETER SC-400
K810745 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 12d
Cleared Mar 31, 1981
AIRWAY PRESSURE MONITOR
K810753 · CAP
Impact Instrumentation, Inc.
Anesthesiology · 11d
Cleared Mar 31, 1981
LUTENIZING HORMONES
K810754 · CEP
Pcl-Ria, Inc.
Chemistry · 11d
Cleared Mar 31, 1981
UROLOGIC TUBE HOLDER
K810787 · OCV
The Urology Group
Gastroenterology & Urology · 8d