FDA.reportPublic FDA data

BAXTER HEALTHCARE CORPORATION

Matched from indexed company URL: Baxter Healthcare

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10190031019003BAXTER HEALTHCARE CORPORATION1N2026-01-01911 NORTH DAVIS CLEVELAND MS US 38732
10251141025114BAXTER HEALTHCARE CORPORATION1N2026-01-0165 Pitts Station Road MARION NC US 28752
13144921314492Baxter Healthcare Corporation1N2026-01-01711 PARK AVE. MEDINA NY US 14103
14169801416980BAXTER HEALTHCARE CORPORATION1N2026-01-0125212 W. ILLINOIS ROUTE 120 ROUND LAKE IL US 60073
14175721417572BAXTER HEALTHCARE CORPORATION1Y2026-01-01ONE BAXTER PARKWAY DEERFIELD IL US 60015
20256952025695BAXTER HEALTHCARE CORPORATION1N2026-01-0117511 Armstrong Ave IRVINE CA US 92614
26496142649614Baxter Healthcare of Puerto Rico LLC1Y2026-01-01RD. 721, KM. 0.3 AIBONITO PR US 00705
29373982937398BAXTER HEALTHCARE CORPORATION1N2026-01-0121026 Alexander Court HAYWARD CA US 94545
30044835083004483508Baxter Healthcare of Puerto Rico LLC1Y2026-01-01530 Road No. 5, Building No. 1 Catano PR US 00962
30073191303007319130Baxter Healthcare Corporation1Y2026-01-01600 SE Maritime Ave --Suite 220 Vancouver WA US 98661
30206583283020658328Baxter Healthcare Corporation - Mt Carmel Global Logistics Center1Y2026-01-01629 Mount Carmel Road Byhalia MS US 38611
10363371036337BAXTER HEALTHCARE CORPORATION1Y2020-04-257511 114TH AVENUE NORTH LARGO FL US 33773
10416731041673BAXTER HEALTHCARE CORPORATION1Y2020-04-254835 SOUTH MENDENHALL RD. Memphis TN US 38141
23149122314912BAXTER HEALTHCARE CORPORATION1N2020-04-251900 NORTH HIGHWAY 201 MOUNTAIN HOME AR US 72653
30064721863006472186Baxter Healthcare Corporation1N2020-04-25835 Maude Avenue Mountain View CA US 94043

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00085412002750DUO-VENT - Nitroglycerin Set with DUO-VENT Spike, PVC Tubing Segment, Injection Site, Male Luer Lock Adapter+1(800)933-0303Medinfo_medproducts@baxter.com
05413765580970RECOTHROM SPRAY KIT - RECOTHROM SPRAY APPLICATOR KIT includes several components designed for topical application of Recothrom onto the bleeding site to aid hemostasis. The spray kit components and packaging are to be used in a sterile environment. The Spray Kit has been designed to be compatible with Recothrom, Thrombin topical (Recombinant) used in the acute care settings of a hospital.+1(866)888-2472medinfo_medproducts@baxter.com
20197886008214Novum IQ - The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725.+1(800)843-7867PumpSupport@Baxter.com
50085412030536NA - HomeChoice Automated PD Set with Cassette and 4-Prong Luers+1(800)553-6898osr.largo@vantive.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
22321273253324P990009FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANTPMX1999-12-08
1874061273253324P990009FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANTPMX1999-12-08
22321915566642P950034SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANEMCN1996-08-12
22321129762826P830063GAMBRO FIBER PLASMAFILTERMDP1986-05-27
22321327442407P210036PerClot® Polysaccharide Hemostatic SystemLMG2023-05-19
22321784347307P100030ARTERX SURGICAL SEALANTNBE2013-03-01
1874061784347307P100030ARTERX SURGICAL SEALANTNBE2013-03-01
2196041784347307P100030ARTERX SURGICAL SEALANTNBE2013-03-01
22321150384849P050011ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTIONMCN2006-07-28
22321127701806P030039COSEAL SURGICAL SEALANTNBE2003-12-12
1874061127701806P030039COSEAL SURGICAL SEALANTNBE2003-12-12
22322016022500K993120MODIFIED BLOOD RECIPIENT SETBRZ1999-11-17
22321661651226K983602CV PERI-GUARD AND VASCU-GUARDDXZ1998-11-12
22451736855456K983557STRYKER WEDGE SUTURE ANCHORMBI1998-12-18
22321271157970K983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCFTM1998-10-09
22321429638166K982818HOSPAL TIPSTOPKMF1998-10-21
22321622433921K982282DURA-GUARD - DURAL REPAIR PATCHGXQ1998-07-30
22321090360578K982102SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CYMEB1998-09-04
22331090360578K982102SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CYMEB1998-09-04
22451432565212K981909BAXTER HEMOSTASIS VALVE INTRODUCERSDYB1998-11-24
22321107440486K981792SOLUTION ADMINISTRATION SETFPA1998-08-17
22321895640739K981624FLO-THRUDXC1998-08-04
22321786497896K981089TISSOMAT AND SPRAY SETFMF2000-07-05
22321307767196K980181TERUMO DISPOSABLE HYPODERMC SYRINGEFMF1998-04-02
22321184039016K973510DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)FMF1997-12-08
22451331841647K973195TOTAL PERFORMANCE SYSTEM SHAVERHRX1997-10-24
22451763157300K972584STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1997-10-01
22451907941364K970714STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)CAC1997-12-16
22321031146449K970663CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)MSF1998-01-11
22321197228725K964853INTRAVIA CONTAINER, EMPTYKPE1997-03-31
22451228707791K963332THERMO-PLASTIC SHAVER BLADESHRX1996-10-11
22321650340440K962581STOPCOCK MANIFOLD GANGSFMG1996-08-28
22321372841784K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493KDJ1996-08-06
22441372841784K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493KDJ1996-08-06
22321567179418K961811PERI-GUARD PERICARDIUMFTM1996-06-13
22321666365631K961810SUPPLE PERI-GUARD PERICARDIUMFTM1996-06-13
22301087831368K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETFPA1996-06-21
22321087831368K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETFPA1996-06-21
22321824354606K960787TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSLJH1996-05-14
22321061035893K952074SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTERFPA1995-07-27
22321421905203K943664INTERMATE XLV ELASTOMERIC INFUSION SYSTEMMEB1994-11-03
22331421905203K943664INTERMATE XLV ELASTOMERIC INFUSION SYSTEMMEB1994-11-03
22451422511568K941333SE5 ARTHROSCOPY SYTEMHRX1994-11-10
22321174432555K932512MULTI-PORT MANIFOLDFMG1994-02-22
22321423609500K932301FENWAL(R) 40/150 MICRON DUAL SCREEN FILTERFPB1993-11-10
22451430227407K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
22321258217975K925403BAXTER APD 12' EXTENSION LINEKDJ1994-02-22
22441258217975K925403BAXTER APD 12' EXTENSION LINEKDJ1994-02-22
22321705606847K925362SUB-Q-SET(R) SUBCUTANEOUS INFUSION SETFPA1993-08-28
22301113167655K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
22321113167655K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
22451113167655K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
22321148953002K925058BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SETFPA1993-08-03
22321138884578K924064INTERLINK UNIVERSAL VIAL ADAPTERLHI1993-04-21
22451138884578K924064INTERLINK UNIVERSAL VIAL ADAPTERLHI1993-04-21
22321938757462K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKX1994-03-04
22441938757462K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKX1994-03-04
22321560835727K921899INTERLINK SYSTEM - T-CONNECTOR EXTENSION SETFPA1993-04-20
22451560835727K921899INTERLINK SYSTEM - T-CONNECTOR EXTENSION SETFPA1993-04-20
22321278301841K9153903 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITESFPA1992-03-12
22451278301841K9153903 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITESFPA1992-03-12
22321226520357K9136273 PORT ADAPTERFPA1991-09-23
22322023739853K910425LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.FRN1991-04-01
22332023739853K910425LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.FRN1991-04-01
22321189814841K905159FLO-RESTER(R) VESSEL SIZERDWP1991-02-07
22321658592167K903159VALVE CONTROLLER FOR MICROMACRO COMPOUNDERLHI1990-11-07
22321509606313K900585TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPLHI1990-04-18
22451099963399K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
22321183366084K883696FLO-RESTERDXC1988-11-30
22321624327006K880733BARD PCA II INFUSION PUMPFRN1988-06-20
22451624327006K880733BARD PCA II INFUSION PUMPFRN1988-06-20
22321232210894K873643GAMBRO ADSORBA 150CFLD1987-12-29
22321958433077K872743BAXA TUBING SETS (FOR PHARMACY PUMP)FMF1987-10-09
22321362768776K870940SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.FPA1987-03-17
22321187337010K8619853M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)MVR1986-12-04
22321417155393K860272SOLUTION ADMINISTRATION SETSFPA1986-03-18
22321994884317K860230CAPD TRANSFER SET SPIKE 5C4363KDJ1986-02-05
22441994884317K860230CAPD TRANSFER SET SPIKE 5C4363KDJ1986-02-05
22321549105150K844904CYTOSAFE NEEDLELHI1985-02-22
22321326295245K844719360 INFUSERFRN1985-01-28
22321240012688K833065AUTOMATIC PERITONEAL DIALYSIS CYCLERFKX1983-11-28
22441240012688K833065AUTOMATIC PERITONEAL DIALYSIS CYCLERFKX1983-11-28
22452019077791K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
22321742206509K832347TWOFER NEEDLELHI1983-09-12
22322040391496K832312I.V. TRANSFER NEEDLELHI1983-09-12
22321151240702K823707HOSPAL BLOOD LINESKOC1983-01-05
22451935663379K823284STRYKER CONSTAVACGCY1983-01-14
22321516586870K811078RADIATION STERILIZED ADMIN. SETFPA1981-07-02
22451516586870K811078RADIATION STERILIZED ADMIN. SETFPA1981-07-02
22321826586959K801016GAMBRO G SERIES BLOOD LINE SETS FOR HEM.FJK1980-05-30
22321559946979K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145KDJ1979-11-13
22441559946979K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145KDJ1979-11-13
22321896882455K791496LOW PLASTICIZER ADMINISTRATION SETSFPA1980-04-08
22321178089802K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN2025-07-28
22322029522958K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN2025-07-28
1415942029522958K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN2025-07-28
22321109568664K243529Solution Administration SetsFPA2025-03-14
22321636521123K242541GEM ZIPCLIPFZP2025-01-15
22321191936889K242390Novum IQ Syringe Pump (40800BAXUS)FRN2024-09-05
22321450618534K242339Intravascular Extension Sets and AccessoriesFPA2025-02-28
22322046945383K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV2024-08-02
22321575679788K233394Gem Flow Now (GEM2770-FN)IYN2024-01-28
22321149472491K230665Dose IQ Safety SoftwarePHC2024-03-29
22321309265803K223175lntravascular Administration Sets with Stopcock and ManifoldFMG2023-03-10
22321259873412K223052Peri-Guard and Supple Peri-GuardFTM2023-04-07
22321922155054K221843GEM Biover Microvascular ClampsDXC2022-09-14
22321910793256K221032Vascu-Guard Vascular Repair PatchPSQ2022-10-19
22321953744486K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchPSQ2022-10-19
22321995474714K220558Blood Administration SetsBRZ2022-11-17
22321380191814K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP TechnologyFTM2021-10-27
22321672499420K212262PCA Syringe SetsFPA2022-10-03
22321341538628K211649PCEA Syringe SetPWH2021-11-23
22321723521360K211122Novum IQ Large Volume PumpFRN2024-03-29
22322011309224K210430Intravascular Extension SetFPA2021-06-18
22321704688170K210335Blood Administration SetBRZ2021-06-10
22321280435961K203609Intravascular Administration SetsFPA2021-09-30
22321017060025K201464Altapore MISMQV2020-06-30
22321877298820K200640ALTAPORE SHAPEMQV2020-05-08
22321756020793K193137EASYGRIP FLO-41 Precision MIS Delivery SystemGCJ2020-01-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA512025-03-14
FRN212025-07-28
KDI152019-07-25
LHI152014-11-19
KDJ132019-10-25
MQV122024-08-02
FKX122015-10-09
FMF102005-05-02
FTM92023-04-07
MVR72019-09-06
MEB72007-05-25
MTJ62010-10-08
FMG52023-03-10
KPO52017-01-06
NBE52013-03-01
DXC42022-09-14
KPE42011-06-14
MEA42005-07-15
BRZ32022-11-17
FLD32014-03-26
FJK32010-11-03
HRX31997-10-24
PSQ22022-10-19
DWP22013-04-24
NDN22012-01-06
FPB22011-12-08
ERL22008-08-26
KHJ22007-01-24
KPF22006-09-11
MCN22006-07-28
PMX21999-12-08
FZP12025-01-15
PHC12024-03-29
IYN12024-01-28
PWH12021-11-23
GCJ12020-01-08
MPB12010-12-21
KRB12010-12-07
DXG12010-07-02
LYC12009-07-30

NDC#

Fosaprepitant

Baxter Healthcare Corporation

Fosaprepitant Dimeglumine

DEXTROSE

Baxter Healthcare Corporation

DEXTROSE MONOHYDRATE

DEXTROSE

Baxter Healthcare Corporation

DEXTROSE MONOHYDRATE

DEXTROSE

Baxter Healthcare Corporation

dextrose monohydrate

DOXIL

Baxter Healthcare Company

doxorubicin hydrochloride

DEXTROSE

Baxter Healthcare Corporation

dextrose monohydrate

DOXIL

Baxter Healthcare Company

doxorubicin hydrochloride

DEXTROSE

Baxter Healthcare Corporation

dextrose monohydrate

DEXTROSE

Baxter Healthcare Corporation

dextrose monohydrate

DEXTROSE

Baxter Healthcare Corporation

dextrose monohydrate

DEXTROSE

Baxter Healthcare Corporation

dextrose monohydrate

Cefazolin

Baxter Healthcare Corporation

Cefazolin Sodium

Ringers

Baxter Healthcare Corporation

sodium chloride, calcium chloride, potassium chloride,

200 records. Showing 1-40. Next

PMA#

Seprafilm Adhesion Barrier

2022-12-22

Baxter Healthcare Corporationone Baxter Parkwaydeerfield, IL 60015 PMA NumberP950034 Supplement NumberS055 Date Received11/23/2022 Decision Date12/22/2022 Product Code MCN  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement...

89 records. Showing 1-40. Next

PMN#

Altapore

2020-01-09

Baxter Healthcare Corporation

ALTAPORE

2018-08-31

Baxter Healthcare Corporation

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next