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
160057–160080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1982
PLATELET AGGREGATION PROFILER #PAP-4
K821005 · JBX
Bio/Data Corp.
Hematology · 50d
Cleared Jun 01, 1982
FREE T4 RADIOIMMUNOASSAY KIT
K821241 · CEC
Bioclinical Group
Chemistry · 33d
Cleared Jun 01, 1982
BBL DIRECTIGEN MENINGITIS TEST KIT
K821266 · GRP
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Jun 01, 1982
#50002 QUAD DIAGNOSTIC SYSTEM
K821301 · JSI
Biomedia, Inc.
Microbiology · 28d
Cleared Jun 01, 1982
#50003 QUAD DIAGNOSTIC SYSTEM
K821302 · JSH
Biomedia, Inc.
Microbiology · 28d
Cleared Jun 01, 1982
DEODORANT SURE & NATURAL MAXISHIELDS
K821375 · HHL
Personal Products Co.
Obstetrics & Gynecology · 22d
Cleared Jun 01, 1982
TRYPTIC SOY AGAR W/10% SHEEP BLOOD
K821417 · JSH
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD
K821418 · JSH
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
EMB AGAR
K821419 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
EMB AGAR
K821420 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
HEKTOEN ENTERIC AGAR
K821421 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
SS AGAR
K821422 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MACCONKEY AGAR
K821423 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
TRYPTIC SOY AGAR W/5% SHEEP BLOOD
K821424 · JSH
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD
K821425 · JSH
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
STAPHYLOCOCCUS MEDIUM 1100
K821426 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MANNITOL SALT AGAR
K821427 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MUELLER HINTON CHOCOLATE MED. ENRICHED
K821428 · JTZ
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MUELLER HINTON MED. W/5% SHEEP BLOOD
K821429 · JTZ
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MUELLER HINTON MEDIUM
K821430 · JTZ
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
XLD AGAR
K821431 · JSI
Interstate Media
Microbiology · 20d
Cleared Jun 01, 1982
MR 600 MICROPLATE READER
K821439 · JJQ
Dynatech Corp.
Chemistry · 19d
Cleared Jun 01, 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
K821441 · CHH
Emd Chemicals, Inc.
Chemistry · 19d
Cleared Jun 01, 1982
HEMACOUNT WRIGHTS STAIN PACK II #55952
K821457 · IAF
Accra Laboratories, Inc.
Hematology · 15d