FDA.reportPublic FDA data

Cardinal Health

FDA Registration(s)#

Registration, FEI, Name table
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
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
30112003343011200334CARDINAL HEALTH1N2026-01-018322 Eagle Palm Drive Riverview FL US 33578
30145247903014524790Cardinal Health1N2020-04-25777 West St. Mansfield MA US 02048
30146521713014652171Cardinal Health1N2020-04-2515 Hampshire Street Building 5 Mansfield MA US 02048

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
18121650604223P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
18141786243629P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ2020-08-07
18001786243629P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ2020-08-07
18001708080471K992171COATED 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
18041361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
18001361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
18001167856607K990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CEZL1999-09-28
18001105770366K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNW1998-12-10
18121079926431K983097TENS/FES/NMES ELECTRODESGXY1999-09-17
18001079926431K983097TENS/FES/NMES ELECTRODESGXY1999-09-17
2210121380092343K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEMKJ1998-05-12
18001380092343K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEMKJ1998-05-12
18002013036509K980582MULTI-LINK CABLE AND LEAD WIRE SYSTEMSDSA1998-03-16
18001048539383K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSMMK1998-02-24
18001149482959K9739112 GALLON ALTERNATE CARE SHARPS CONTAINERFMI1997-10-29
18042008243961K973763KENDALL CURITY IODOFORM PACKING STRIPEFQ1997-12-31
18002008243961K973763KENDALL CURITY IODOFORM PACKING STRIPEFQ1997-12-31
18041389919682K973619KENDALL CURITY NON-ADHERING DRESSINGKMF1997-12-10
18001389919682K973619KENDALL CURITY NON-ADHERING DRESSINGKMF1997-12-10
18001922813762K973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETEREZD1997-11-07
18041130224761K973511KENDALL CURITY PETROLATUM GAUZEFRO1997-12-16
18001130224761K973511KENDALL CURITY PETROLATUM GAUZEFRO1997-12-16
18041808379718K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)FRO1997-12-15
18141808379718K973507KENDALL 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
18001404415970K973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPSKNT1998-02-27
2210121800430269K972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEMKJ1997-08-27
18141863910526K972615CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)LYY1999-01-26
18142025394619K964523RECOVER INFANT HEEL WARMER (5100)MPO1997-02-10
2210121789458758K964425A-V IMPULSE SYSTEM MODEL 6060JOW1997-07-28
18001789458758K964425A-V IMPULSE SYSTEM MODEL 6060JOW1997-07-28
18002064461347K964387POINT OF USE II SHARPS-A-GATORMMK1997-03-27
18001334968856K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)KXO1997-01-22
18102071643354K963351LIFESHIELD BLUNT CANNULAFMI1997-02-26
18002071643354K963351LIFESHIELD BLUNT CANNULAFMI1997-02-26
18121737949878K962332TENS/FES/NMES ELECTRODESGZJ1996-07-31
18001737949878K962332TENS/FES/NMES ELECTRODESGZJ1996-07-31
18002063513226K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)MLS1996-07-03
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
18001424226738K960632KANGAROO FEEDING TUBE PLACMENT STYLETKNT1996-05-09
2210121734939279K955882MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORSMKJ1996-10-24
18001734939279K955882MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORSMKJ1996-10-24
2210121226064530K955828MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORSMKJ1996-07-25
18001744219563K955557FLUID REISISTANT EYESHIELD MASKFXX1996-04-25
18001651252754K955556FLUID RESISTANT MASKFXX1996-04-25
18001410904504K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KITKNT1996-03-08
18141479934668K952945AQUAFLO HYDROGEL WOUND DRESSING & PACKERNAE1995-08-23
18001479934668K952945AQUAFLO HYDROGEL WOUND DRESSING & PACKERNAE1995-08-23
18001692515996K951738ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETERFOS1995-09-29
18001520111184K951737ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAYFOS1995-09-28
18001141994175K951488KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPKNY1995-04-25
18041395102172K950775CURASORB ZN ALGINATE WOUND DRESSINGKMF1995-04-03
18001395102172K950775CURASORB ZN ALGINATE WOUND DRESSINGKMF1995-04-03
18001448308029K945964KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETSLZH1995-03-07
18002033670327K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMF1995-03-01
18102033670327K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMF1995-03-01
18112033670327K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMF1995-03-01
18001447629998K945197THE SHARPS COLLECTION AND DISPOSAL SYSTEMMMK1994-12-02
18001090429166K943660PHLEBOTOMY SHARPS DISPOSAL CONTAINERSMMK1995-03-22
18001761496785K943659ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERSMMK1995-03-22
18001110216040K943658CHEMOTHERAPY WASTE DISPOSAL CONTAINERSMMK1995-03-22
18041386553081K943636CURADERM ALGINATE HYDROCOLLOIDKMF1994-10-03
18001386553081K943636CURADERM ALGINATE HYDROCOLLOIDKMF1994-10-03
18001021679419K943485MONOJECT HORIZONTAL ENTRY SHARPS CONTAINERFMI1994-09-09
18041055013909K943073CURAFIL WOUND GEL DRESSINGMGQ1994-07-26
18141055013909K943073CURAFIL WOUND GEL DRESSINGMGQ1994-07-26
18001055013909K943073CURAFIL WOUND GEL DRESSINGMGQ1994-07-26
18001397274496K942564ARGYLE NEO-SERTFOS1994-08-25
18041545861418K942459CURASALT HYPERTONIC SALINE DRESSINGKMF1994-06-27
18041300126997K942394SAFE VENT SYSTEMFMF1995-01-27
18001006887919K941991IN-ROOM AND SHARPSTARMMK1994-08-29
18001134769465K941814ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETERFOS1994-09-30
18001355492268K935238ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAYFRG1994-02-17
18001383954608K935238ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAYFRG1994-02-17
18001447254740K934428ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAYLRO1993-12-30
18001042555650K933751LIFESHIELD BLOOD COLLECTION DEVICEFMI1994-02-14
18041510856336K933689MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSINGKMF1993-12-13
18001510856336K933689MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSINGKMF1993-12-13
18001739989981K933520ENDOSCOPIC ANTI-FOG KIT, 100-302-00GCJ1993-08-24
18001393520071K933400KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSORKOD1993-11-15
18001426742463K932295NON-BALLOON REPLACEMENT GASTROSTOMY KITKNT1994-09-08
18122045243925K925466CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLONGYB1993-08-26
18111921238133K922522MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZESFMF1992-11-25
18001921238133K922522MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZESFMF1992-11-25
18001358925768K922468ANGEL WING SETS -- MODIFIEDGIM1992-07-10
18001172064431K920908OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1DYB1992-10-06
18112037631339K920713FIRSTTEMP GENIUSFLL1992-12-17
18002037631339K920713FIRSTTEMP GENIUSFLL1992-12-17
18001504791272K920184ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.GIM1992-02-18
18121903825189K915333ELECTRODE USING PROMEON RG-60 SERIES GELGXY1992-01-14
18001903825189K915333ELECTRODE USING PROMEON RG-60 SERIES GELGXY1992-01-14
18111530063874K915213CORVAC BLOOD COLLECTION TUBEGIM1992-01-08
18001530063874K915213CORVAC BLOOD COLLECTION TUBEGIM1992-01-08
18121865907223K914871TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GELGZJ1991-12-18
18001819465309K914375NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBEKNT1992-03-06
18001040794042K913914PROGUARDII(TM) BLOOD COLLECTION DEVICEFMI1991-10-08
18001165334787K913784DOBBHOFF(R) SINGLE PASS PEG KITKNT1992-01-15
18001635947863K912563ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SEFOZ1991-10-02
18141716227141K904745MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODEHGP1991-01-29
18001716227141K904745MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODEHGP1991-01-29
18001668475705K903340STERILE URETHRAL CATHETER PROCEDURE KITSFCM1990-10-04
18121936902823K902719SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECTGXY1990-07-19
18001936902823K902719SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECTGXY1990-07-19
18121816660311K901575REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTRODGXY1990-05-02
18001816660311K901575REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTRODGXY1990-05-02
18121791821283K900997K-STERILE TENS ELECTRODESGXY1990-03-13
18001791821283K900997K-STERILE TENS ELECTRODESGXY1990-03-13
18001426046216K900590BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDINGKNT1990-08-02
18001215770488K900563DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATHKNT1990-08-02
18121680423017K896936L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAPGXY1990-01-22
18001680423017K896936L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAPGXY1990-01-22
18001723229424K892442KENDALL CURITY URETHRAL CATHETERSGBM1989-06-23
18111176670037K883320MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBEJKA1988-09-27
18001176670037K883320MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBEJKA1988-09-27
18121446965924K882809THYMAPADGXY1988-09-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNT242018-10-23
GXY232012-10-15
JOW222023-04-03
FMF212025-08-22
FMI182001-10-25
KGO172021-09-26
FRO122009-02-26
GIM121992-07-10
FYA102026-04-28
LZH102022-12-20
OMP92021-06-04
KOD92004-07-20
KMF91997-12-10
PIF82022-05-19
FLL82006-05-22
PNR72024-12-19
FXX72023-07-03
EZL72005-01-18
MMK71998-02-24
LZA62026-09-02
FOS62013-04-17
MKJ61998-05-12
GZJ42001-01-24
LZC32026-01-14
FRG32018-12-11
DXN32016-10-14
DRO32001-10-12
MGQ31994-07-26
JKA31988-09-27
DWF31984-10-18
MEG22023-06-21
MKJ 22020-08-07
FEG22004-05-17
NAD22000-01-31
EFQ21997-12-31
NAE21995-08-23
HGP21991-01-29
GBM21989-06-23
KPE21981-09-16
KDH21977-03-09

NDC#

83 records. Showing 1-40. Next

PMA#

PMN#