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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142393–142416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1986
UNIDEX GLUCOSE TEST STRIP
K862984 · CGA
Unidex, Inc.
Chemistry · 90d
Cleared Nov 05, 1986
THEOFAST(TM) TEST PACKAGE
K863475 · LER
3M Company
Chemistry · 57d
Cleared Nov 05, 1986
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
K863490 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Nov 05, 1986
LYTENING 2
K863521 · JGS
Amdev, Inc.
Chemistry · 56d
Cleared Nov 05, 1986
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
K863738 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Nov 05, 1986
HCG CONTROL KIT
K863744 · JJX
Monoclonal Antibodies, Inc.
Chemistry · 42d
Cleared Nov 05, 1986
VMAX KINETIC MICROPLATE READER
K863802 · JJQ
Molecular Devices Corp.
Chemistry · 37d
Cleared Nov 05, 1986
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
K863840 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Nov 05, 1986
SMI MULTIPETTOR(TM)
K863887 · JQW
American Dade
Chemistry · 30d
Cleared Nov 05, 1986
DU PONT PHENYTOIN ASSAY AND CALIBRATOR
K863888 · DIR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 30d
Cleared Nov 05, 1986
WIDEX HEARING AID MODEL ES2
K864097 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 15d
Cleared Nov 05, 1986
LIGACLIP 20/20* MULTIPLE CLIP APPLIER
K864102 · FZP
Ethicon, Inc.
General & Plastic Surgery · 15d
Cleared Nov 05, 1986
RANFAC CUT BIOPSY NEEDLE
K864139 · GAA
Ranfac, Corp.
General & Plastic Surgery · 14d
Cleared Nov 05, 1986
DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)
K864146 · GDW
Cardio Thoracic Systems
General & Plastic Surgery · 14d
Cleared Nov 05, 1986
SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES
K864175 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 12d
Cleared Nov 05, 1986
INTEGRA, CUSTOM IN-THE-EAR HEARING AID
K864180 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 9d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT SET-RPLA
K855233 · GTN
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT VET-RPLA
K855234 · GNA
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT PET-RPLA
K855235 · JSP
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT TST-RPLA
K855236 · GTN
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
SHEATH, ENDOSCOPE
K862059 · FGE
Endovations
Gastroenterology & Urology · 158d
Cleared Nov 04, 1986
EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER
K862164 · IYO
Hitachi Medical Corp. of America
Radiology · 151d
Cleared Nov 04, 1986
CRAIG NASO-GASTRIC TUBE HOLDER
K862855 · KNT
Henley Intl.
Gastroenterology & Urology · 98d
Cleared Nov 04, 1986
CARDIOSCAN WITH DOPPLER OPTION
K862913 · JOP
Interspec, Inc.
Cardiovascular · 95d