Baxter Healthcare Corporation

FDA Filings

This page includes the latest FDA filings for Baxter Healthcare Corporation. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Baxter Healthcare Corporation
Prismax System Version 32020-03-13
Baxter Healthcare Corporation
Altapore2020-01-09
Baxter Healthcare Corportation
EASYGRIP FLO-41 Precision MIS Delivery System2020-01-08
Baxter Healthcare
MiniCap Extended Life PD Transfer Sets2019-10-25
Baxter Healthcare Corporation
Altapore Shape2019-10-19
Baxter Healthcare Corp
PrisMax System Version 22019-07-25
Baxter Healthcare Corporation
Clearlink System Solution Set2019-05-28
Baxter Healthcare Corporation
ALTAPORE2018-08-31
Baxter Healthcare Corporation
Actifuse Flow2018-08-17
Baxter Healthcare Corporation
Spectrum IQ Infusion System, Dose IQ Safety Software2018-05-11
Baxter Healthcare Corporation
Prismaflex System 8.102018-02-23
Baxter Healthcare Corporation
IV Fat Emulsion Administration Sets2017-09-22
Baxter Healthcare Corporation
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices 2017-07-24
Baxter Healthcare Corporation
Solution Set With 1.2 Micron Air Eliminating Filter2017-06-21
BAXTER HEALTHCARE CORP
Prismax Control Unit2017-05-03
Baxter Healthcare Corporation
PrismaSATE2017-01-06
BAXTER HEALTHCARE CORPORATION
Paclitaxel Sets2016-12-19
BAXTER HEALTHCARE CORPORATION
Solution Set For Epidural Use2016-11-30
BAXTER HEALTHCARE CORPORATION
Solution Administration Sets With 0.2 Micron Filter2015-12-28
BAXTER HEALTHCARE
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER2015-10-29
BAXTER HEALTHCARE CORPORATION
FlexiCap Disconnect Cap With Povidone-Iodine Solution, MiniCap With Povidone-Iodine Solution2015-10-29
BAXTER HEALTHCARE CORPORATION
Nitroglycerin Sets With DUO-VENT Spike2015-04-16
BAXTER HEALTHCARE CORPORATION
VIAL-MATE Adaptor2014-11-19
BAXTER HEALTHCARE CORPORATION
SOLUTION SET/EXTENSION SET2014-08-18
BAXTER HEALTHCARE CORPORATION
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY2014-05-07
BAXTER HEALTHCARE CORP.
Ultrafuse2014-04-08
BAXTER HEALTHCARE CORP.
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS2013-10-08
BAXTER HEALTHCARE CORP.
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO2013-03-01
BAXTER HEALTHCARE CORP.
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S2013-01-10
BAXTER HEALTHCARE CORP.
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET2013-01-08

Latest Premarket Applications

PMAManufacturerDevice NameDate
BAXTER HEALTHCARE CORP.
Floseal Hemostatic Matrix2019-12-20
BAXTER HEALTHCARE CORP.
Floseal Hemostatic Matrix2019-07-19
BAXTER HEALTHCARE CORP.
ADEPT Adhesion Reduction Solution2019-06-03
BAXTER HEALTHCARE CORP.
Floseal Hemostatic Matrix2019-05-15
BAXTER HEALTHCARE CORP.
Floseal NT2019-04-18
BAXTER HEALTHCARE CORP.
FLOSEAL Hemostatic Matrix2019-03-22
BAXTER HEALTHCARE CORP.
Floseal Hemostatic Matrix2019-03-04
Baxter Healthcare Corporation
PreveLeak Surgical Sealant2017-12-21
Baxter Healthcare Corporation
Water for Injection Sterile, USP2017-11-20
BAXTER HEALTHCARE CORP.
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT2017-11-09
BAXTER HEALTHCARE CORP.
Floseal Hemostatic Matrix2017-11-08
BAXTER HEALTHCARE CORP.
FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips2017-11-01
Baxter Healthcare Corporation
PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips2017-08-30
Baxter Healthcare Corporation
PreveLeak Surgical Sealant2017-08-25
Baxter Healthcare Corporation
PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips2017-08-21
Baxter Healthcare Corporation
PreveLeak Surgical Sealant & 10pk applictor tips2017-05-19
BAXTER HEALTHCARE CORP.
Floseal Hemostatie Matrix2017-05-11
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2017-02-10
BAXTER HEALTHCARE CORP.
FLOSEAL MATRIX HEMOSTATIC SEALANT2017-01-04
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2016-11-22
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2016-09-14
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2015-08-21
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2015-07-16
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2015-02-26
Baxter Healthcare Corporation
PREVELEAK SURGICAL SEALANT2014-07-31
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2014-05-27
BAXTER HEALTHCARE CORP.
FLOSEAL HEMOSTATIC MATRIX2013-12-24
Baxter Healthcare Corporation
ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES2013-11-25
Baxter Healthcare Corporation
ARTERX SURGICAL SEALANT,2013-11-05
BAXTER HEALTHCARE CORP.
ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)2013-10-29

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
REPEATER
BAXTER HEALTHCARE CORPORATION2020-03-13
REPEATER
BAXTER HEALTHCARE CORPORATION2020-03-13
therMaxTherMax Blood Warmer
BAXTER HEALTHCARE CORPORATION2020-02-10
prisMaxPrisMax System
BAXTER HEALTHCARE CORPORATION2020-02-10
therMaxTherMax Blood Warmer
BAXTER HEALTHCARE CORPORATION2020-02-10
CLEARLINK
BAXTER HEALTHCARE CORPORATION2019-12-11
MINICAP WITH POVIDONE-IODINE SOLUTION
BAXTER HEALTHCARE CORPORATION2019-11-12
PRISMASATE
BAXTER HEALTHCARE CORPORATION2019-11-04
CLEARLINK/BURETROL
BAXTER HEALTHCARE CORPORATION2019-10-08
ABACUS
BAXTER HEALTHCARE CORPORATION2019-07-09
ABACUS
BAXTER HEALTHCARE CORPORATION2019-07-09
ABACUS
BAXTER HEALTHCARE CORPORATION2019-07-09
ABACUS
BAXTER HEALTHCARE CORPORATION2019-07-09
NA
BAXTER HEALTHCARE CORPORATION2019-05-13
EXACTAMIX
BAXTER HEALTHCARE CORPORATION2019-04-16
TipStop
BAXTER HEALTHCARE CORPORATION2019-03-04
NA
BAXTER HEALTHCARE CORPORATION2019-02-28
Easy-Lock
BAXTER HEALTHCARE CORPORATION2018-12-17
Floseal
BAXTER HEALTHCARE CORPORATION2018-07-06
Floseal
BAXTER HEALTHCARE CORPORATION2018-07-06
Floseal Hemostatic Matrix
BAXTER HEALTHCARE CORPORATION2018-03-29
Floseal Hemostatic Matrix
BAXTER HEALTHCARE CORPORATION2018-03-29
Floseal Hemostatic Matrix
BAXTER HEALTHCARE CORPORATION2018-03-29
Floseal Hemostatic Matrix
BAXTER HEALTHCARE CORPORATION2018-03-29
Gelfoam Plus
BAXTER HEALTHCARE CORPORATION2018-03-29
Gelfoam Plus
BAXTER HEALTHCARE CORPORATION2018-03-29
Floseal Special Applicator Tips
BAXTER HEALTHCARE CORPORATION2018-03-29
Coseal Surgical Sealant
BAXTER HEALTHCARE CORPORATION2018-03-29
Coseal Surgical Sealant
BAXTER HEALTHCARE CORPORATION2018-03-29
Coseal Surgical Sealant
BAXTER HEALTHCARE CORPORATION2018-03-29
Gelfoam Plus
BAXTER HEALTHCARE CORPORATION2018-03-29
Coseal Surgical Sealant Extended Applicator
BAXTER HEALTHCARE CORPORATION2018-03-29
Coseal Surgical Sealant Replacement Applicator
BAXTER HEALTHCARE CORPORATION2018-03-29

Related Finance Registrations
Baxter Healthcare SA of SWITZERLAND0001582211
Legal Entity Identifier 529900GAS83W3FLWRI14 [Baxter Healthcare GmbH]
Legal Entity Identifier 549300R5DQDIBMVQY334 [BAXTER HEALTHCARE LIMITED]
Legal Entity Identifier 5493000KZT2BJP2WPH84 [Baxter Healthcare SA]

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