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
160825–160848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1982
COAT-A-COUNT PROGESTERONE KIA KIT
K820534 · JLS
Diagnostic Products Corp.
Chemistry · 14d
Cleared Mar 16, 1982
THIOGLYCOLLATE W/INDICATOR
K820549 · JSG
American Laboratory Supply, Inc.
Chemistry · 14d
Cleared Mar 16, 1982
EOSIN METHYLENE BLUE AGAR
K820552 · JSI
American Laboratory Supply, Inc.
Microbiology · 14d
Cleared Mar 16, 1982
BILE ESCULIN AZIDE AGAR
K820553 · JSI
American Laboratory Supply, Inc.
Microbiology · 14d
Cleared Mar 16, 1982
COLUMBIZ CNA AGAR W/15% SHEEP BLOOD
K820554 · JSJ
American Laboratory Supply, Inc.
Microbiology · 14d
Cleared Mar 16, 1982
ANAEROBE BLOOD AGAR W/KANAMYCIN & VANCO
K820555 · JSJ
American Laboratory Supply, Inc.
Microbiology · 14d
Cleared Mar 16, 1982
TRYPTIC SOY AGAR
K820556 · JSG
American Laboratory Supply, Inc.
Microbiology · 14d
Cleared Mar 16, 1982
SELENITE BROTH
K820558 · JSD
American Laboratory Supply, Inc.
Microbiology · 14d
Cleared Mar 16, 1982
THIOGLYCOLLATE ENRICHED
K820563 · KZI
American Laboratory Supply, Inc.
Chemistry · 14d
Cleared Mar 15, 1982
METEC HELARIUM LOUNGE & SKY UNITS
K812225 · FTC
Klafs Sunlight Corp.
Radiology · 217d
Cleared Mar 15, 1982
NUTRICATH
K813374 · FOZ
Exco, Inc.
General Hospital · 104d
Cleared Mar 15, 1982
TRANSLUMINAL BIPOLAR PACING PROBE
K813521 · LDF
American Edwards Laboratories
Cardiovascular · 89d
Cleared Mar 15, 1982
AXIOM LIG-A-BOOTS
K820161 · KDC
Axiom Medical, Inc.
General & Plastic Surgery · 54d
Cleared Mar 15, 1982
PACEMAKER PROGRAMMER 2030
K820230 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 46d
Cleared Mar 15, 1982
COMMAND ULTRA I
K820231 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 46d
Cleared Mar 15, 1982
PROMPT INOCULATION SYSTEM
K820299 · LIE
3M Company
Microbiology · 39d
Cleared Mar 15, 1982
NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV
K820334
Nemectron Medical, Inc.
Neurology · 38d
Cleared Mar 15, 1982
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
K820400 · JPK
Ortho Diagnostic Systems, Inc.
Hematology · 31d
Cleared Mar 15, 1982
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
K820401 · JPK
Orhto Diagnostic Systems, Inc.
Hematology · 31d
Cleared Mar 15, 1982
EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO
K820440 · LDN
Syva Co.
Toxicology · 26d
Cleared Mar 15, 1982
CENTRIFREE MICROPARTITION SYSTEM
K820455 · JRL
Amicon, Inc.
Chemistry · 24d
Cleared Mar 15, 1982
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · DTM
C.R. Bard, Inc.
Cardiovascular · 24d
Cleared Mar 15, 1982
IDA RAPID O2A SYSTEM
K820483 · JSP
Innovative Diagnostic Systems, Inc.
Microbiology · 21d
Cleared Mar 15, 1982
TENS MODEL 8201
K820496 · GZJ
Medical Scientific Instruments
Neurology · 20d