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
168457–168480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1979
TRYPTIC SOY AGAR 5% SHEEP BLOOD
K791620 · JSG
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
MANNITOL SALT AGAR
K791621 · JSI
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
COLUMBIA AGAR WITH5% SHEEP
K791622 · JSG
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
MUELLER-HINTON AGAR
K791624 · JTZ
American Laboratory Supply, Inc.
Microbiology · 34d
Cleared Sep 24, 1979
AO TEACHING ATTACHMENT, MODEL TA-1
K791635 · FEA
American Optical Corp.
Gastroenterology & Urology · 34d
Cleared Sep 24, 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640 · CDT
Coulter Electronics, Inc.
Chemistry · 34d
Cleared Sep 24, 1979
SGPT REAGENT SET MODIFICATION
K791641 · CKA
American Monitor Corp.
Chemistry · 34d
Cleared Sep 24, 1979
SYSTEM CONTROLLER 720 SERIES
K791661 · KIE
Waters Assoc., Inc.
Toxicology · 34d
Cleared Sep 24, 1979
GLUCOSE OXIDASE REAGENT SET
K791669 · CGA
Macomb Chemical Co.
Chemistry · 27d
Cleared Sep 24, 1979
NADH OXIDATION, AST/SGOT
K791679 · CIT
American Monitor Corp.
Chemistry · 27d
Cleared Sep 24, 1979
CONTRO I
K791695 · JJY
Hi Chem, Inc.
Chemistry · 55d
Cleared Sep 24, 1979
CONTRO II
K791696 · JJY
Hi Chem, Inc.
Chemistry · 55d
Cleared Sep 24, 1979
INORGANIC PHOSPHORUS REAGENT
K791708 · CEO
Gilford Diagnostics
Chemistry · 27d
Cleared Sep 24, 1979
HEEL/ELBOW PROTECTORS
K791709 · FMP
Fibre Formations, Inc.
General Hospital · 28d
Cleared Sep 24, 1979
PROCAST
K791831 · ITG
Medical Specialties, Inc.
Physical Medicine · 6d
Cleared Sep 21, 1979
EMISONIC 4290
K791429 · IYO
Emi Medical, Inc.
Radiology · 57d
Cleared Sep 21, 1979
SELF CHECK
K791762 · DTC
Instromedix, Inc.
Cardiovascular · 24d
Cleared Sep 21, 1979
CONPHAR UMBILICAL CORD CLAMP
K791800 · GDJ
Conphar, Inc.
General & Plastic Surgery · 8d
Cleared Sep 21, 1979
CONPHAR FINGERTIP SUCTION CONTROL
K791801 · JOL
Conphar, Inc.
General Hospital · 8d
Cleared Sep 21, 1979
CONPHAR TUBE CLAMPS
K791802 · GDJ
Conphar, Inc.
General & Plastic Surgery · 8d
Cleared Sep 21, 1979
CONPHAR CATHETER PLUG
K791803 · KGZ
Conphar, Inc.
General & Plastic Surgery · 8d
Cleared Sep 21, 1979
CONPHAR ADAPT-CONNECTS STERILE, NONSTE.
K791806 · KGZ
Conphar, Inc.
General & Plastic Surgery · 8d
Cleared Sep 20, 1979
MODEL 221 PROGRAMALITH PULSE GENERATOR
K790873 · DXY
Pacesetter Systems
Cardiovascular · 136d
Cleared Sep 20, 1979
PROGRAMMER, MEDTRONIC MODEL 5984/5985
K791181 · DXY
Medtronic Vascular
Cardiovascular · 87d