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
170329–170352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1979
DYONICS STEROTOXIC POSITIONER
K790502 · HAW
Dyonics, Inc.
Neurology · 23d
Cleared Apr 04, 1979
KNEE SYSTEM, QUADRAXIAL CONSTRAINED
K781971 · KRO
Hexcel Medical
Orthopedic · 128d
Cleared Apr 04, 1979
PREGNANCY, SENSIDEX TUBE TEST
K782063 · JHJ
Ortho Diagnostics, Inc.
Chemistry · 114d
Cleared Apr 04, 1979
SLIDE TEST FOR PREGNANCY, GRAVINDEX 90
K782166 · JHJ
Ortho Diagnostics, Inc.
Chemistry · 96d
Cleared Apr 04, 1979
ATOMIZER, FURNACE MODEL HGA-400
K790111 · JXR
The Perkin-Elmer Corp.
Toxicology · 76d
Cleared Apr 04, 1979
STANDARD PECTORALIS MUSCLE IMPLANT
K790245
Medical Engineering Corp.
General & Plastic Surgery · 57d
Cleared Apr 04, 1979
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
K790248 · CFJ
Boehringer Laboratories
Chemistry · 55d
Cleared Apr 04, 1979
LIQUISOL CORTISOL RIA TEST KIT
K790250
Damon Corp.
Toxicology · 57d
Cleared Apr 04, 1979
SPECTACLE FRAMES
K790266 · HQZ
Alva-Tech, Inc.
Ophthalmic · 57d
Cleared Apr 04, 1979
CORTISOL RIA KIT
K790268 · CGR
E. R. Squibb & Sons, Inc.
Toxicology · 58d
Cleared Apr 04, 1979
ANALYZER, CENTRIFUCHEM SYSTEM 400
K790278 · JJG
Union Carbide Corp.
Chemistry · 54d
Cleared Apr 04, 1979
RADIOASSAY, CONTROL SERUM I, II, III
K790298 · DGR
Kallestad Laboratories, Inc.
Immunology · 51d
Cleared Apr 04, 1979
CPK ISOENZYME SUBSTRATE
K790309 · JHY
Electrophoresis Corp.
Hematology · 50d
Cleared Apr 04, 1979
A-GENT-HDL REAGENT
K790329 · LBR
Abbott Laboratories
Immunology · 47d
Cleared Apr 04, 1979
UNION CARBIDE CORP. COMPUTER INTERFACE
K790336 · JQP
Union Carbide Corp.
Chemistry · 42d
Cleared Apr 04, 1979
COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER
K790338 · FDF
American Optical Corp.
Gastroenterology & Urology · 42d
Cleared Apr 04, 1979
DELTA-NET
K790341 · KKX
Johnson & Johnson Professionals, Inc.
General Hospital · 42d
Cleared Apr 04, 1979
CPK-CS
K790357 · JHT
Hoffmann-La Roche, Inc.
Chemistry · 40d
Cleared Apr 04, 1979
URINE CULTURE KIT
K790366 · JTW
Bd Becton Dickinson Vacutainer...
Microbiology · 41d
Cleared Apr 04, 1979
MACOMB LIPID CONTROL
K790371 · JJY
Macomb Chemical Co.
Chemistry · 41d
Cleared Apr 04, 1979
DUPONT ACA CKMB VERIFIERS
K790376 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 40d
Cleared Apr 04, 1979
FEEDING TUBE W/ LUBRICANT COATING
K790387 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 04, 1979
HCP-7
K790415 · JPK
Bioscientific
Hematology · 37d
Cleared Apr 04, 1979
FACTOR V DEFICIENT
K790423 · GGP
Sigma Chemical Co.
Hematology · 34d