Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
169561–169584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1979
ANTISERUM TO RABBIT IMMUNOGLOBULIN
K790709 · DFZ
Kent Laboratories, Inc.
Immunology · 126d
Cleared Aug 16, 1979
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI
K790712 · DDB
Kent Laboratories, Inc.
Immunology · 126d
Cleared Aug 16, 1979
ANTISERUM TO HUMAN CERULOPLASMIN
K790714 · DDB
Kent Laboratories, Inc.
Immunology · 126d
Cleared Aug 16, 1979
ANTISERUM TO HUMAN FC
K790715 · DAS
Kent Laboratories, Inc.
Microbiology · 126d
Cleared Aug 16, 1979
ANTISERA TO RABBIT IMMUNOGLOBULIN
K790720 · DFZ
Kent Laboratories, Inc.
Immunology · 126d
Cleared Aug 16, 1979
GALVANIC UNIT
K790949 · ISB
Rami International Corp.
Physical Medicine · 87d
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