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
175129–175152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1976
RADIOASSAY, CONCEPT 4
K760006
Micromedic Systems
Chemistry · 43d
Cleared Jul 20, 1976
COLORIMETRIC DETERMINATION (LDH)
K760009 · CFH
The Dow Chemical Co.
Chemistry · 40d
Cleared Jul 20, 1976
PACER SYSTEMS ANALYZER (CORDIS)
K760013 · DTC
Cordis Corp.
Cardiovascular · 40d
Cleared Jul 20, 1976
CONSIOUS SEDATION (ANALOR P-76)
K760017 · BZR
Mckesson Corp.
Anesthesiology · 39d
Cleared Jul 20, 1976
VACUUM TUBES, STERILE (J-VAC)
K760018 · GIM
Jelco Laboratories
Hematology · 39d
Cleared Jul 20, 1976
VACUUM TUBES, PEDIATRIC SIZES (J-VAC)
K760019 · GIM
Jelco Laboratories
Hematology · 39d
Cleared Jul 20, 1976
DSP - STAIN PACK
K760027 · IAF
Harleco
Hematology · 36d
Cleared Jul 20, 1976
HISTOCHEMICAL PAS REACTION SET
K760031 · HZT
Harleco
Hematology · 36d
Cleared Jul 20, 1976
KIT, RADIOASSAY, SERUM IRON
K760045 · JJA
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Jul 20, 1976
KIT, RIA, GENTAMICIN SULF.
K760068 · DJB
New England Nuclear
Toxicology · 34d
Cleared Jul 20, 1976
TUMBLER, PERSONAL, ROUND, 9 OUNCE
K760070
Bemis Health Care
General Hospital · 32d
Cleared Jul 20, 1976
TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4
K760071
Bemis Health Care
General Hospital · 32d
Cleared Jul 20, 1976
CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR
K760072
Bemis Health Care
General Hospital · 32d
Cleared Jul 20, 1976
BASIN, WASH, 6-QT RECTANGULAR
K760073 · LDQ
Bemis Health Care
General & Plastic Surgery · 32d
Cleared Jul 20, 1976
KIT, MORPHINE (TOXI-PAK IMMUNO HI)
K760074 · DLR
J.T. Baker Chemical Co.
Toxicology · 32d
Cleared Jul 20, 1976
KIT, METHADONE (TOXI-PAK IMMUNO HI)
K760075 · DIW
J.T. Baker Chemical Co.
Toxicology · 32d
Cleared Jul 20, 1976
REAGENT, RIA TRIIODOTHYRONINE T3 (#200)
K760078 · CDP
Oxford Laboratories, Inc.
Chemistry · 32d
Cleared Jul 20, 1976
REAGENT, THYROXINE T4 (#210)
K760079 · CDX
Oxford Laboratories, Inc.
Chemistry · 32d
Cleared Jul 20, 1976
PHYSIOSCOPE
K760083
Narco Bio-Systems
Radiology · 29d
Cleared Jul 20, 1976
BASIN, STERILE (#3200)
K760085 · FNY
Concord Laboratories, Inc.
General Hospital · 29d
Cleared Jul 20, 1976
TAPE, VASCULAR, 1/4 DACRON
K760087 · DWS
Meadox Medicals, Div. Boston...
Cardiovascular · 29d
Cleared Jul 20, 1976
TEST, IN-VITRO DIAGNOSTIC
K760089
Hoffmann-La Roche, Inc.
Immunology · 29d
Cleared Jul 20, 1976
GRAFT, COOLEY GUIDELINE, STERILE
K760090 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 29d
Cleared Jul 20, 1976
GRAFT, MICROVEL GUIDELINE, STERILE
K760091 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 29d