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
156649–156672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1983
CORNING'S MAGIC T3(125I) RADIOIMMUNO-
K832353 · CDP
Corning Medical & Scientific
Chemistry · 44d
Cleared Aug 31, 1983
IDT ANA STIQ ASSAY
K832383 · DHN
Intl. Diagnostic Technology
Immunology · 43d
Cleared Aug 31, 1983
CENTRAL VENOUS ACCESS CATHETER CVAC
K832396 · DOY
Gish Biomedical, Inc.
Toxicology · 42d
Cleared Aug 31, 1983
HYBRITECH 405-500 NM FILTER MODULE
K832397 · JJQ
Hybritech, Inc.
Chemistry · 42d
Cleared Aug 31, 1983
ENZYMATIC TRIGLYCERIDES #2000
K832444 · CDT
Stanbio Laboratory
Chemistry · 37d
Cleared Aug 31, 1983
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
K832445 · LCD
American Dade
Chemistry · 37d
Cleared Aug 31, 1983
ENEMA TUBE
K832501 · KNT
Cone Instruments, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 31, 1983
RECLINING WHEELS
K832511 · INN
Reclining Wheels
Physical Medicine · 35d
Cleared Aug 31, 1983
MONOJET SAMPLETTE ADAPTERS
K832578 · GIO
Sherwood Medical Co.
Hematology · 29d
Cleared Aug 31, 1983
VESSEL DILATOR
K832595 · DWP
Abbott Laboratories
Cardiovascular · 29d
Cleared Aug 26, 1983
FR ROOT CANAL FILLER
K830763 · KIF
Shizai Corp.
Dental · 169d
Cleared Aug 26, 1983
HEMOPERFUSION SYSTEM TP-400
K831029 · FLD
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 149d
Cleared Aug 26, 1983
P.C.A. HIP SYSTEM
K831373 · JDI
Howmedica Corp.
Orthopedic · 121d
Cleared Aug 26, 1983
TACTIL EAR
K831501 · LRA
Ear Three Systems
Ear, Nose, Throat · 107d
Cleared Aug 26, 1983
COLLINS EAGLE II
K831779 · BZC
Warren E. Collins, Inc.
Anesthesiology · 85d
Cleared Aug 26, 1983
RAICHEM ACID PHASPHATASE REAGENT
K831834 · CKB
Reagents Applications, Inc.
Chemistry · 80d
Cleared Aug 26, 1983
FIAX CRP TEST KIT
K832054 · DCK
Intl. Diagnostic Technology
Immunology · 60d
Cleared Aug 26, 1983
ROBIN CORDLESS HANDPIECE
K832063 · EKX
Kaycor Intl., Ltd.
Dental · 60d
Cleared Aug 26, 1983
COATEST FACTOR X
K832114 · GGP
Kabivitrum, Inc.
Hematology · 57d
Cleared Aug 26, 1983
MARK III OXYGEN WALKER SYS. RESERVOIR
K832143 · BYJ
Linde Div. Union Carbide Corp.
Anesthesiology · 52d
Cleared Aug 26, 1983
CLIRANS TAF06 HOLLOW FIBER DIALYZER
K832252 · KOC
Terumo Medical Corp.
Gastroenterology & Urology · 46d
Cleared Aug 26, 1983
VISI-FLOW IRRIGATOR
K832299 · EXD
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 44d
Cleared Aug 26, 1983
ONPG DISCS
K832307 · JTO
Oxoid U.S.A., Inc.
Microbiology · 43d
Cleared Aug 26, 1983
PHOTON IMMUNOASSAY ANALYZER
K832364 · JJQ
Hybritech, Inc.
Chemistry · 39d