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
168721–168744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1979
RUBAZYME
K790976 · GOL
Abbott Laboratories
Microbiology · 85d
Cleared Aug 16, 1979
THE DENVER SPLINT
K791053 · EPP
Ronald D. Shippert, M.D.
Ear, Nose, Throat · 71d
Cleared Aug 16, 1979
ELECTROSURGICAL GENERATOR (TIM)
K791230 · GEI
Concept, Inc.
General & Plastic Surgery · 41d
Cleared Aug 16, 1979
CADWELL 7000 ELECTROMYOGRAPH MACHINE
K791235 · IKN
Cadwell Laboratories, Inc.
Neurology · 41d
Cleared Aug 16, 1979
MEDICOR QUALITY CONTROL BUFFER
K791287 · JJS
Medicor USA , Ltd.
Chemistry · 37d
Cleared Aug 16, 1979
SPIROCAL
K791294 · BXX
Equilibrated Bio Systems, Inc.
Anesthesiology · 37d
Cleared Aug 16, 1979
CPK ISOENZYME CONTROL
K791299 · JJT
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Aug 16, 1979
LDH ISOENZYME CONTROL
K791300 · JJT
Electrophoresis Corp. of America
Chemistry · 31d
Cleared Aug 16, 1979
MANUAL MICRO ELISA READER #2-530
K791302 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 37d
Cleared Aug 16, 1979
CATALOG #4-2520 CHLORIDOMETER CHLORIDE
K791312 · JIT
Buchler Instruments, Inc.
Chemistry · 36d
Cleared Aug 16, 1979
ARS, CHEMISTRY
K791313 · JJY
Mid Tech, Inc.
Chemistry · 35d
Cleared Aug 16, 1979
SPECTRO-SUR SET
K791315 · JIS
Helena Laboratories
Chemistry · 31d
Cleared Aug 16, 1979
AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM
K791325 · DPO
Micromedic Systems
Toxicology · 35d
Cleared Aug 16, 1979
HUMAN CERULOPLASMIN
K791339 · DDB
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 16, 1979
HUMAN ALPHA2 MACROGLOBULIN
K791340 · DEB
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 16, 1979
HUMAN ALPHA, ACID GLYCOPROTEIN
K791341 · DEX
Beckman Instruments, Inc.
Immunology · 31d
Cleared Aug 16, 1979
T3 UPTAKE RADIOIMMUNOASSAY KIT
K791361 · KHQ
Technia Diagnostics , Ltd.
Chemistry · 27d
Cleared Aug 16, 1979
COCCIDIODES (COCCI)
K791381 · GMG
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
K791382 · GMD
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
CANDIDA IMMUNODIFFUSION KIT #CA1001
K791383 · GMI
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
FUNGAL IMMUNODIFFUSION KIT #ID1001
K791384 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
NEGATIVE CONTROL SERUM FOR CF RO ID
K791385 · GSN
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
K791386 · KFG
Immuno-Mycologics, Inc.
Microbiology · 36d
Cleared Aug 16, 1979
ASPERGILLUS MYCELIAL ANTIGEN #CF10024X
K791387 · JWT
Immuno-Mycologics, Inc.
Microbiology · 36d