FDA.reportPublic FDA data

Cardinal Health K.K.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30123414253012341425Cardinal Health K.K.1N2026-01-013033 MOROI FUKUROI Shizuoka JP 437-1121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2788922033670327K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMF1995-03-01
2788921305327072K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingKGO2016-07-11
2788921209182954K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)KGO2016-05-12
2788921698664657K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingKGO2016-03-24
2788921430633260K113707STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATINGKGO2012-04-27
2788921700620217K111878PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVESKGO2011-09-29
2788921572506414K111868STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATINGKGO2011-09-21
2788921632721333K111015STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATINGKGO2011-05-06
2788921418659319K110272STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGKGO2011-06-08
2788921480048330K101811PROTEGRITY SMT LATEX SURGICALGLOVESKGO2010-10-15
2788921683188004K100306KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVESJOW2010-05-04
2788921773807266K093300ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVESKGO2009-10-30
2788921422466338K092304ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVESKGO2009-09-15
2788921798473935K040511SCD EXPRESS PORTABLE COMPRESSION SYSTEMJOW2004-06-28
2788921457588286K040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSLZH2004-05-05
2788921077244898K001924COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0KGO2000-07-14
2788921090438895
2788921636673667
2788921699386182
2788921871867992
2788921952336698

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO122016-07-11
JOW22010-05-04
LZH12004-05-05
FMF11995-03-01