Baxter S A

FDA Filings

This page includes the latest FDA filings for Baxter S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device Company	Device	Date
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2024-12-13
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2024-09-18
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2024-08-16
CLINIMIX Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2024-07-15
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2024-06-30
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2024-06-19
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2024-05-09
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2024-05-02
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2024-04-25
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2024-03-14
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2024-03-10
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-12-30
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2023-12-29
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2023-12-20
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-11-04
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-10-25
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2023-08-23
CLINIMIX Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-08-19
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2023-06-02
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-05-13
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-04-27
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-02-15
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2023-02-09
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2022-12-30
CLINIMIX Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2022-12-17
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2022-12-14
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2022-09-24
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2022-08-05
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2022-07-07
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2022-07-03
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2021-12-31
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2021-12-31
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2021-11-17
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2021-11-09
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2021-11-04
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2021-07-24
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2021-07-15
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2021-06-22
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2021-04-21
CLINIMIX Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2021-04-17
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2021-04-17
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-12-30
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-12-29
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2020-12-24
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2020-11-14
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-11-14
CLINIMIX Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-11-10
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-11-03
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-10-08
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2020-10-08
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-10-07
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-10-03
CLINIMIX Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-10-01
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-07-01
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2020-05-01
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2020-04-29
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2020-02-06
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2019-12-20
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2019-12-07
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2019-10-25
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2019-09-18
Clinolipid Baxter Healthcare Corporation, Baxter SA, Baxter R&D Europe SPRL	Prescription Medication	2019-07-03
Fluconazole Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2019-06-15
CLINIMIX E Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2019-05-14
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2019-05-07
DIANEAL Low Calcium with Dextrose Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Baxter SA	Prescription Medication	2019-04-02
Travasol Baxter Healthcare Corporation, PACE ANALYTICAL INC., Baxter SA	Prescription Medication	2019-01-11
CLINIMIX Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2018-11-17
ProSol Baxter Healthcare Corporation, Baxter SA	Prescription Medication	2018-11-17

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BAXTER CENTRE FOR MEDICAL RESEARCH
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 Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BAXTER HEALTHCARE CORP.32650 N Wilson Rdround Lake, IL 60073 PMA NumberP990009 Supplement NumberS071 Date Received10/26/2022 Decision Date11/22/2022 Product Code PMX Advisory Committee General & Plastic Surgery Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
BAXTER INTERNATIONAL, INC.1 Baxter Pkwy.deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS024 Date Received10/18/2022 Decision Date11/08/2022 Product Code MDP Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BAXTER HEALTHCARE CORP.32650 N Wilson Rdround Lake, IL 60073 PMA NumberP990009 Supplement NumberS069 Date Received04/22/2022 Decision Date05/20/2022 Product Code PMX Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BAXTER INTERNATIONAL, INC.1 Baxter Pkwy.deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS023 Date Received03/29/2022 Decision Date04/07/2022 Product Code MDP Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BAXTER INTERNATIONAL, INC.1 Baxter Pkwy.deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS022 Date Received03/02/2022 Decision Date03/31/2022 Product Code MDP Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Baxter Aktiengesellschaft
Baxter Aktiengesellschaft (AG)
Baxter Deutschland GmbH
Baxter Healthcare (Shanghai) Co. Ltd.
Baxter Healthcare S.A.
Baxter Hospitalar Ltda.
BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED
Baxter, S.A. de C.V.
Baxter Healthcare Corporation
PACE ANALYTICAL INC.
Baxter R&D Europe SPRL

Related Finance Registrations

NCAGE Code	B2338	BAXTER SA
CAGE Code	B2338	BAXTER SA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092294064	South Riding Point,Bahamas -> Port Everglades, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - HS NO: 90189031 100 BOXES ON 5 PALLET S 2400 EA 955419 NOVALINE BL 05 R - HEMODIALI SIS EQUIPMENT NET WEIGHT: 923.00 KGS PRODUCTO MEDICO NO FUMIGAR / MEDICAL SUPPLIES DO NOT FUMIGATE	5 BOX
20200917100722	South Riding Point,Bahamas -> Port Everglades, Florida	INSTRUMENTS AND APPLIANCES USED IN MEDICAL, S URGIC - HS NO: 90189031 100 BOXES ON 5 PALLET S 2400 EA 955419 NOVALINE BL 05 R - HEMODIALI SIS EQUIPMENT NET WEIGHT: 923.00 KGS PRODUCTO MEDICO NO FUMIGAR / MEDICAL SUPPLIES DO NOT FUMIGATE	5 BOX
2019071828853	Anvers,Belgium -> Charleston, South Carolina	100 CARTONS - 50 PAL SHIP REF : 19010464/1I/08159 INVOICE : 19002839 MEDICAL SUPPLIES HSCODE: 39232910	100 PKG
2019071242476	Anvers,Belgium -> Charleston, South Carolina	100 CARTONS - 50 PAL SHIP REF : 19010464/1I/08159 INVOICE : 19002839 MEDICAL SUPPLIES HSCODE: 39232910	100 PKG
2019070865481	Anvers,Belgium -> Charleston, South Carolina	MEDICAL PRODUCTS GW: 20750 KGS VGMW: 24350 KGS CALCULATED 37.319 CUBIC METERS 99 CARTONS ON 50 PALLETS	99 PKG
201906142614	Anvers,Belgium -> Charleston, South Carolina	LOADED ON 50 PALLETS MEDICAL EQUIPMENT PRODUCTS FOR MEDICAL USE AND/OR THEIR COMPONENTS HS CODE: 39232910	100 PKG
2019061438596	Anvers,Belgium -> Charleston, South Carolina	98 CARTONS LOADED ON 49 PALLETS MEDICAL EQUIPMENT PRODUCTS FOR MEDICAL USE AND/OR THEIR COMPONENTS HSCODE:39232910	98 PKG
2019051346807	Anvers,Belgium -> Charleston, South Carolina	LOADED ON 50 PALLETS MEDICAL EQUIPMENT PRODUCTS FOR MEDICAL USE AND/OR THEIR COMPONENTS HS CODE: 39232910	100 PKG