FDA.reportPublic FDA data

EIKON DEVICE INC.

Matched from indexed company URL: Eikon-Device-Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103635423010363542EIKON DEVICE INC.1N2026-01-01689 Innovation Drive Kingston Ontario CA K7K 7E6

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1597101025786476K982872TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1998-10-15
1597101543655722K970794LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)LYY1997-05-06
1597101791874296K955426STERITEC CROSS-CHECKSJOJ1996-03-12
1597101952331707K941327CROSSTEX SELF-SEALING STERILIZATION POUCHKCT1994-12-22
1597101668211476K895077SURGICAL MASK/DENTAL MASKFXX1989-11-03
1597102048102681K190606Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileLZA2019-05-28
1597101076647933K112266POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLORLYZ2012-05-08
1597101799001473K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THANLYY2010-06-25
1597101654134185K100603RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)LZA2010-07-16
1597101831460866K090194POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLORLZA2009-07-07
1597101781877751K071886SELF SEAL STERILIZATION POUCHFRG2007-12-27
1597101693463361K071740CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVESLZA2007-10-04
1597101111162180K061553NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVESLZA2006-07-17
1597101727045956K060073TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELINGLZA2006-05-01
1597102061367838K051291NON-STERILE SURGICAL MASKFXX2005-09-20
1597101626876243K022091BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVESLYZ2002-12-30
1597102072282555K000999MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)LYY2000-05-22
1597101024887981
1597101205279048
1597101239163150
1597101330272123
1597101429769878
1597101441174600
1597101509428310
1597101638257376
1597101704498360
1597101785484958

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA62019-05-28
LYY42010-06-25
LYZ22012-05-08
FXX22005-09-20
FRG12007-12-27
JOJ11996-03-12
KCT11994-12-22