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
168217–168240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD
K792052 · DXY
Telectronics, Inc.
Cardiovascular · 7d
Cleared Oct 17, 1979
ANTI-HUMAN SERUM
K791282 · DGQ
Diagnostica, Inc.
Immunology · 99d
Cleared Oct 17, 1979
ANTI-HUMAN GLOBULINS
K791285 · DEW
Diagnostica, Inc.
Immunology · 99d
Cleared Oct 17, 1979
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
K791326 · DZI
Sherwood Medical Co.
Dental · 97d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGA
K791401 · CZP
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGM
K791402 · DFT
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-IGG
K791403 · DEW
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
LANCER L-INA ANTI-C3
K791404 · CZW
Sherwood Medical Co.
Immunology · 79d
Cleared Oct 17, 1979
CULTURE AND SENSITIVITY KIT
K791413 · JTZ
Biomedia, Inc.
Microbiology · 79d
Cleared Oct 17, 1979
DTM (DERMATOPHYTE TEST MEDIUM) AGAR
K791414 · JSI
Biomedia, Inc.
Microbiology · 79d
Cleared Oct 17, 1979
HI-M-TEST MORPHINE
K791551 · DLR
Technam, Inc.
Toxicology · 64d
Cleared Oct 17, 1979
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY
K791596 · KLB
Bio-Rad
Toxicology · 63d
Cleared Oct 17, 1979
A-GENT GLYCOSPEC
K791642 · LCP
Abbott Laboratories
Hematology · 55d
Cleared Oct 17, 1979
WRIGHT STAIN PACK
K791658
Bioscientific
Hematology · 57d
Cleared Oct 17, 1979
BE-SURE
K791706 · JHJ
Precision Products Corp.
Chemistry · 61d
Cleared Oct 17, 1979
CENTRIA INSULIN RIA
K791707 · CFP
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Oct 17, 1979
IMPROVED GRAM STAIN REAGENTS
K791711 · HYI
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 50d
Cleared Oct 17, 1979
BIO-BAG ENVIRONMENTAL CHAMBER (A & B)
K791724 · JTX
Marion Laboratories, Inc.
Microbiology · 48d
Cleared Oct 17, 1979
CHOLINESTERASE REAGENT
K791725 · DIH
Gilford Diagnostics
Toxicology · 47d
Cleared Oct 17, 1979
INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL
K791749 · DAA
Clinical Sciences, Inc.
Immunology · 37d
Cleared Oct 17, 1979
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
K791770 · DJB
Bio-Rad
Toxicology · 40d
Cleared Oct 17, 1979
ANTISERUM TO HUMAN IMMUNOGLOBULINS
K791824 · DEW
Icl Scientific
Immunology · 33d
Cleared Oct 17, 1979
BAYONET HEIFETZ CLIP APPLIERS
K791845 · GDO
Edward Weck, Inc.
General & Plastic Surgery · 28d
Cleared Oct 17, 1979
CENTRIA TSH RIA
K791855 · JLW
Union Carbide Corp.
Chemistry · 28d