FDA.report

Cardinal Health

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10177681017768Cardinal Health1N2026-01-012010 E International Speedway Blvd DELAND FL US 32724
10181201018120Cardinal Health1N2026-01-011430 Marvin Griffin Rd AUGUSTA GA US 30906
10339031033903Cardinal Health1N2026-01-01525 Emerald Rd N Greenwood SC US 29646
12191031000148701Cardinal Health1N2026-01-012 Ludlow Park Dr CHICOPEE MA US 01022
14235373001236905Cardinal Health 200, LLC1Y2026-01-013651 Birchwood Drive Waukegan IL US 60085
16234861623486CARDINAL HEALTH 200, LLC1N2026-01-01200 MCKNIGHT ST. Jacksonville TX US 75766
19154841915484Cardinal Health1N2026-01-011222 SHERWOOD RD. Norfolk NE US 68701
19218461921846Cardinal Health1N2026-01-01444 JAMES SOUTH MCDONNELL BLVD. Hazelwood MO US 63042
21831641000116809Cardinal Health1N2026-01-011313 WEST GRANT BLVD. Wabasha MN US 55981
26401383003370911CARDINAL HEALTH P.R. 218, INC.1N2026-01-01STATE RD. 402 NORTH KM 0.9 ANASCO PR US 00610
26474373010176616CARDINAL HEALTH P.R. 120, INC1Y2026-01-01BLDN. 10 LOCAL A, Road 165 KM 2.4 INTL. DISTRIBUTION CENTER Guaynabo PR US 00965
30048392273004839227Cardinal Health Malta 212 Ltd1N2026-01-01A51, Industrial Estate Marsa MT MRS3000
30056274253005627425Cardinal Health 108 DBA METRO-PACIFICA LLC1Y2026-01-01233 Mason Road La Vergne TN US 37086
30056744643005674464CARDINAL HEALTH SINGAPORE 225 PTE LTD1N2026-01-0110 KALLANG AVENUE #10-10/18 APERIA SINGAPORE Central Singapore SG 339510
30073290203007329020Cardinal Health 200, LLC1N2026-01-011320 Don Haskins Suite A El Paso TX US 79936
30112003343011200334CARDINAL HEALTH1N2026-01-018322 Eagle Palm Drive Riverview FL US 33578
30123414253012341425Cardinal Health K.K.1N2026-01-013033 MOROI FUKUROI Shizuoka JP 437-1121
30146566683014656668Cardinal Health C/O Avarto Benelux BV1N2026-01-01Brem 1 Heijen Limburg NL 6598 MH
10658313002973487CARDINAL HEALTH 200, LLC1N2020-04-25785 FORT MILL HWY. FORT MILL SC US 29707
14233393003473306Cardinal Health Medical Distribution1Y2020-04-252101 Waukegan Road Waukegan IL US 60085
16232231623223CARDINAL HEALTH 200, LLC1Y2020-04-251 Butterfield Trail Blvd EL PASO TX US 79906
19403731940373CARDINAL HEALTH 200, LLC1N2020-04-25808 W Highway 24 MOBERLY MO US 65270
30043311003004331100Cardinal Health 200 LLC1Y2020-04-258640 Nail ROad Olive Branch MS US 38654
30055845703005584570Cardinal Health 108 DBA METRO-PACIFICA LLC1Y2020-04-256640 Echo Ave Ste J Reno NV US 89506
30056274193005627419Cardinal Health 108 DBA METRO-PACIFICA LLC1Y2020-04-2515 Ingram Boulevard Suite #240 La Vergne TN US 37086

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
18121650604223P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
167311786243629P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ 2020-08-07
18141786243629P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ 2020-08-07
18001786243629P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ 2020-08-07
167311124380504K993463INTRAVASCULAR ADMINISTRATION SETFPA2000-01-04
167201488739097K993063RUSCH BRILLANT SILICONE FOLEYEZL1999-12-09
167311488739097K993063RUSCH BRILLANT SILICONE FOLEYEZL1999-12-09
167311419056458K992436GOWN BACK, MODEL 13-403N; 13-404N; 13-405NFYA2000-01-20
167201419056458K992436GOWN BACK, MODEL 13-403N; 13-404N; 13-405NFYA2000-01-20
18001708080471K992171COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO1999-09-14
167201708080471K992171COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO1999-09-14
167311708080471K992171COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO1999-09-14
18111624338852K991758MONOJECT INSULIN SYRINGEFMF1999-06-14
18001624338852K991758MONOJECT INSULIN SYRINGEFMF1999-06-14
167311624338852K991758MONOJECT INSULIN SYRINGEFMF1999-06-14
167421361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
18001361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
18041361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
167311361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
18001167856607K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CEZL1999-09-28
167311167856607K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CEZL1999-09-28
167201312298735K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
167201787004860K984084BARDEX LUBRI-SIL FOLEY CATHETEREZL1999-02-01
167311173586416K983952GREINER VACUETTE BLOOD COLLECTION TUBEJKA1998-12-28
167311105770366K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNW1998-12-10
18001105770366K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNW1998-12-10
18001079926431K983097TENS/FES/NMES ELECTRODESGXY1999-09-17
18121079926431K983097TENS/FES/NMES ELECTRODESGXY1999-09-17
167311079926431K983097TENS/FES/NMES ELECTRODESGXY1999-09-17
167311128759395K982652ALLEGIANCE PORTA-WARM MATTRESSIMD1999-01-21
167321128759395K982652ALLEGIANCE PORTA-WARM MATTRESSIMD1999-01-21
167311178803548K982269CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GAMIA1998-07-23
167201303122369K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
167311303122369K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
167201273306565K980987BECTON DICKINSON SYRINGEFMF1998-06-11
167311380092343K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEMKJ1998-05-12
18001380092343K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEMKJ1998-05-12
167311048539383K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSMMK1998-02-24
18001048539383K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSMMK1998-02-24
167201126950132K980210VARIOUS SURGICAL OR PATIENT DRAPESKKX1998-05-15
18001149482959K9739112 GALLON ALTERNATE CARE SHARPS CONTAINERFMI1997-10-29
167311149482959K9739112 GALLON ALTERNATE CARE SHARPS CONTAINERFMI1997-10-29
18002008243961K973763KENDALL CURITY IODOFORM PACKING STRIPEFQ1997-12-31
18042008243961K973763KENDALL CURITY IODOFORM PACKING STRIPEFQ1997-12-31
167312008243961K973763KENDALL CURITY IODOFORM PACKING STRIPEFQ1997-12-31
18001389919682K973619KENDALL CURITY NON-ADHERING DRESSINGKMF1997-12-10
167311389919682K973619KENDALL CURITY NON-ADHERING DRESSINGKMF1997-12-10
18041389919682K973619KENDALL CURITY NON-ADHERING DRESSINGKMF1997-12-10
18001922813762K973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETEREZD1997-11-07
167311922813762K973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETEREZD1997-11-07
18001130224761K973511KENDALL CURITY PETROLATUM GAUZEFRO1997-12-16
18041130224761K973511KENDALL CURITY PETROLATUM GAUZEFRO1997-12-16
167311130224761K973511KENDALL CURITY PETROLATUM GAUZEFRO1997-12-16
18141808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
953261808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
167311808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
18001808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
18041808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
18001404415970K973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPSKNT1998-02-27
167311404415970K973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPSKNT1998-02-27
167201001287964K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1997-09-19
167311001287964K972901AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1997-09-19
18141863910526K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)LYY1999-01-26
167311863910526K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)LYY1999-01-26
167311992835261K971849CYTOLOGY BRUSHHHT1997-07-24
167201870701616K971540AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORDGEI1997-08-14
167311984010685K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAFTL1997-07-01
167311155289470K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)GIM1997-06-17
167201155289470K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)GIM1997-06-17
167311943067778K971339INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERSFOZ1997-12-24
167201943067778K971339INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERSFOZ1997-12-24
167201471648673K971159SURGICAL DRAPESKKX1997-06-24
167311722998498K970855CLAVE CONNECTORFPA1997-06-24
167202050628551K970554CONVERTORS SMS DRAPESKKX1997-05-27
18142025394619K964523RECOVER INFANT HEEL WARMER (5100)MPO1997-02-10
167311450476331K964435PRIMARY IV SETFMG1997-04-02
167201450476331K964435PRIMARY IV SETFMG1997-04-02
18001789458758K964425A-V IMPULSE SYSTEM MODEL 6060JOW1997-07-28
167311789458758K964425A-V IMPULSE SYSTEM MODEL 6060JOW1997-07-28
167312064461347K964387POINT OF USE II SHARPS-A-GATORMMK1997-03-27
18002064461347K964387POINT OF USE II SHARPS-A-GATORMMK1997-03-27
167311334968856K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)KXO1997-01-22
18001334968856K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)KXO1997-01-22
167201067409825K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
167312071643354K963351LIFESHIELD BLUNT CANNULAFMI1997-02-26
18102071643354K963351LIFESHIELD BLUNT CANNULAFMI1997-02-26
18002071643354K963351LIFESHIELD BLUNT CANNULAFMI1997-02-26
18001737949878K962332TENS/FES/NMES ELECTRODESGZJ1996-07-31
18121737949878K962332TENS/FES/NMES ELECTRODESGZJ1996-07-31
167311737949878K962332TENS/FES/NMES ELECTRODESGZJ1996-07-31
18002063513226K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)MLS1996-07-03
167312063513226K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)MLS1996-07-03
167311335882377K961341CONVERTORS POLYOLEFIN FABRIC GOWNSFYA1996-10-28
167421335882377K961341CONVERTORS POLYOLEFIN FABRIC GOWNSFYA1996-10-28
167321782414199K961154BAXTER SODIUM ACETATE INFANT HEEL WARMERMPO1996-06-06
167311782414199K961154BAXTER SODIUM ACETATE INFANT HEEL WARMERMPO1996-06-06
167311752693403K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAFMI1996-12-23
18111752693403K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAFMI1996-12-23
18101752693403K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAFMI1996-12-23
18001752693403K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAFMI1996-12-23
18001279582537K960677KANGAROO JEJUNAL FEEDING SYSTEMKNT1996-05-13
167311279582537K960677KANGAROO JEJUNAL FEEDING SYSTEMKNT1996-05-13
18001424226738K960632KANGAROO FEEDING TUBE PLACMENT STYLETKNT1996-05-09
167311424226738K960632KANGAROO FEEDING TUBE PLACMENT STYLETKNT1996-05-09
18001734939279K955882MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORSMKJ1996-10-24
167311734939279K955882MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORSMKJ1996-10-24
167311538100439K955785TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SETDYB1996-03-12
167201538100439K955785TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SETDYB1996-03-12
18001744219563K955557FLUID REISISTANT EYESHIELD MASKFXX1996-04-25
167311744219563K955557FLUID REISISTANT EYESHIELD MASKFXX1996-04-25
18001651252754K955556FLUID RESISTANT MASKFXX1996-04-25
167261651252754K955556FLUID RESISTANT MASKFXX1996-04-25
167311651252754K955556FLUID RESISTANT MASKFXX1996-04-25
167201373308482K954853AUTO SUTURE SUTURE CLOSUREGCJ1995-12-20
167311373308482K954853AUTO SUTURE SUTURE CLOSUREGCJ1995-12-20
167311410904504K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KITKNT1996-03-08
18001410904504K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KITKNT1996-03-08
167311050007029K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1995-10-18
167201050007029K953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORDGEI1995-10-18
18001479934668K952945AQUAFLO HYDROGEL WOUND DRESSING & PACKERNAE1995-08-23

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KNT532018-10-23
KGO492021-09-26
FMF362025-08-22
GXY322012-10-15
FYA302023-07-27
JOW292023-04-03
FMI272001-10-25
GIM261997-06-17
KOD242004-07-20
LZH202022-12-20
FXX182023-07-03
FRO182009-02-26
EZL172007-12-07
LZA152024-08-23
PIF142022-05-19
GEI142003-03-07
MMK141998-02-24
KMF141997-12-10
PNR122024-12-19
FOS122013-04-17
FOZ121999-08-20
OMP112021-06-04
FRG112018-12-11
FLL112006-05-22
LZC102026-01-14
KKX102005-04-25
GCJ82003-10-30
DWF81988-03-22
DXN62016-10-14
DQO62005-12-22
FEG62004-05-17
FPA62000-01-04
JKA61998-12-28
DQX52009-02-06
DYB52002-07-03
GZJ52001-01-24
EFQ51997-12-31
FMG51997-04-02
DTL51990-08-15
LYZ42016-07-25

NDC

Cetirizine

Cardinal Health 107, LLC

Cetirizine Hydrochloride

BACLOFEN

Cardinal Health 107, LLC

baclofen

Jardiance

Cardinal Health 107, LLC

Empagliflozin

Jardiance

Cardinal Health 107, LLC

Empagliflozin

ELIQUIS

Cardinal Health 107, LLC

apixaban

ELIQUIS

Cardinal Health 107, LLC

apixaban

200 records. Showing 1-40. Next

PMA

PMN

102 records. Showing 1-40. Next

Applications

GUDID

200 records. Showing 1-40. Next