Baxter Healthcare S A

FDA Filings

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

FDA Registration(s)

• Registration Number: 2649614
• FEI Number: 2649614
• Name: BAXTER HEALTHCARE S.A.
• Owner & Operator: BAXTER HEALTHCARE CORPORATION
• Contact Address: One Baxter Parkway --; Deerfield IL 60015 US
• Official Correspondent:
  • Thomas P Sampogna
  • x-224-9483016-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: RD. 721, KM. 0.3 ; AIBONITO, PR 00705 US
• Establishment Type:
  • Manufacture Medical Device
  • Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
EXTRANEAL Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-11-09
DIANEAL LOW CALCIUM WITH DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-11-09
EXTRANEAL Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-11-09
DIANEAL LOW CALCIUM WITH DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-11-09
Acetaminophen Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-11-01
levetiracetam Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-10-31
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-09-26
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-09-20
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2024-08-30
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-28
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-28
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-22
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-16
levetiracetam Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-15
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2024-08-10
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-09
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-06
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-06
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-08-02
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-07-31
GUDID 50085412908439 Baxter Healthcare SA	Revaclear 114745A	2024-04-22
GUDID 50085412908422 Baxter Healthcare SA	Revaclear 114746A	2024-04-22
GUDID 50085412908392 Baxter Healthcare SA	Revaclear 955543A	2024-04-22
levetiracetam Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2024-04-20
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-12-30
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-12-30
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2023-12-22
Acetaminophen Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-12-21
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
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2023-12-06
levetiracetam Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-10-11
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-08-24
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
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-08-23
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-08-22
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-07-20
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-07-20
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2023-06-27
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2023-05-26
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2023-02-23
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-02-11
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-01-06
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2023-01-06
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-12-30
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-12-23
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-12-23
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-12-23
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-12-23
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
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-12-13
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-12-08
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2022-11-30
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2022-10-20
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-08-27
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-08-18
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-08-18
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2022-07-02
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2022-06-19
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-04-07
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-03-18
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-03-18
Acetaminophen Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-01-21
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2022-01-16
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2022-01-11
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-12-31
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2021-12-31
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-12-31
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-12-31
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
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-12-08
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-12-08
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-12-08
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-12-05
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
Acetaminophen Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-10-09
Acetaminophen Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-10-06
Acetaminophen Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-09-22
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-08-19
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-08-19
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2021-07-03
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-07-01
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
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2021-06-09
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-03-20
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-03-18
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-03-16
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-03-07
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-03-07
NOREPINEPHRINE BITARTRATE Baxter Healthcare Corporation, Baxter Healthcare S.A., Bieffe Medital S.p.A.	Prescription Medication	2021-01-28
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-01-15
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2021-01-15
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2020-12-30
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2020-12-29
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	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
MAGNESIUM SULFATE IN DEXTROSE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2020-08-20
Sodium Chloride Baxter Healthcare Corporation, Baxter, S.A. de C.V., Baxter Healthcare S.A., Bieffe Medital SA	Prescription Medication	2020-08-13
SODIUM CHLORIDE Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2020-08-12
Magnesium Sulfate Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2020-06-13
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2020-03-20
Dextrose Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2020-03-19
Sodium Chloride Baxter Healthcare Corporation, Baxter Healthcare S.A.	Prescription Medication	2020-02-12
FHQ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2017-12-21
PMN K073633 | ERL BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2017-02-22
PMN K042457 | LJH BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-25
PMN K983557 | MBI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K983557 | GAT BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K972233 | HWC BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K972069 | FQH BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K970714 | CAC BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K955599 | LZN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K955599 | GDY BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K952460 | HWC BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K944210 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K941605 | LXH BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K931847 | LZN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K912190 | JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K130430 | NDN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K130430 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K120824 | MBI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K113477 | NDN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K113477 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K103807 | NDN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K103807 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K093419 | NDN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K093419 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K032945 | NDN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K032945 | LOD BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K032943 | KNW BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K011381 | ERL BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K011319 | JDW BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
OAR BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
NBH BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
LXH BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
GFF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
GFA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
EQJ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
DXC BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2015-11-24
PMN K142011 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Solution Sets, Extension Sets	2014-08-25
PMN K142011 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Duo-Vent	2014-08-25
PMN K142011 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2014-08-25
PMN K823284 | GCY BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	2013-12-20
PMN K132734 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	One-Link	2013-12-20
PMN K132734 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec	2013-12-20
PMN K130245 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Stopcock and I.V. Solution Administration Sets with Stopcocks	2013-03-07
PMN K130245 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2013-03-07
PMN K130245 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2013-03-07
PMN K130245 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Clearlink	2013-03-07
PMN K130245 | FMG BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Stopcock and I.V. Solution Administration Sets with Stopcocks	2013-03-07
PMN K130245 | FMG BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2013-03-07
PMN K130245 | FMG BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2013-03-07
PMN K130245 | FMG BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Clearlink	2013-03-07
PMN K981909 | DYB BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Advanced Venous Access AVA 3xi	2012-12-05
PMN K925638 | DXO BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	DPT	2012-12-05
PMN K896819 | KRA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	VAMP	2012-12-05
PMN K832554 | DXC BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Fogarty	2012-12-05
PMN K100739 | KRB BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Volume View	2012-12-05
PMN K973195 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Suction Regulator	2012-11-28
PMN K973195 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Angled Agg Meniscus	2012-11-28
PMN K972584 | ERL BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Sinuflow Suction Irrigator	2012-11-28
PMN K963646 | GEI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Strykeflow Single Spike Tube Set	2012-11-28
PMN K963646 | GEI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	StrykeFlow PS	2012-11-28
PMN K963646 | GEI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	StrykeFlow II with Connected Tubing	2012-11-28
PMN K963646 | GEI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	StrykeFlow II 10" Suction Irrigator	2012-11-28
PMN K963332 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Suction Regulator	2012-11-28
PMN K963332 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Angled Agg Meniscus	2012-11-28
PMN K954726 | GCX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Strykeflow Disposable S/I Tip	2012-11-28
PMN K954726 | GCX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Strykeflow 2 with Tip	2012-11-28
PMN K941333 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Suction Regulator	2012-11-28
PMN K941333 | HRX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Angled Agg Meniscus	2012-11-28
PMN K934094 | GCJ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Strykeflow Disposable S/I Tip	2012-11-28
PMN K934094 | GCJ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Strykeflow 2 with Tip	2012-11-28
PMN K042454 | KQT BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Dual Spike Cassette Tube Set	2012-11-28
PMN K042454 | KQT BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Cassette Tube Set	2012-11-28
PMN K042454 | KQT BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Cassette Tube Set with tip	2012-11-28
PMN K042454 | HET BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Dual Spike Cassette Tube Set	2012-11-28
PMN K042454 | HET BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Cassette Tube Set	2012-11-28
PMN K042454 | HET BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Cassette Tube Set with tip	2012-11-28
PMN K042454 | GCX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Dual Spike Cassette Tube Set	2012-11-28
PMN K042454 | GCX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Cassette Tube Set	2012-11-28
PMN K042454 | GCX BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Ahto Cassette Tube Set with tip	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Small Prox. Press (W/O Hub)	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Revolution Humeral Nozzle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Revolution Cancellous Nozzle w/Press Kit	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Revolution CMS w/ Femoral Breakaway Nozzle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Revolution 65 Posterior Femoral Press Nozzle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	PCD, W/O Needle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	PCD, 11G Needle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	High Vac.Mix.Bowl with Femoral Nozzle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	High Vac. Mix Bowl	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Femoral Nozzle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	AutoPlex w/o Needle Int.	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	65 deg. Post. Fem. Press	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	180 gr. Cartridge	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	180 gr. Cartridge With Femoral Nozzle	2012-11-28
JDZ BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	100mm Femoral Nozzle	2012-11-28
HWE BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	The Mill Disposable - Medium	2012-11-28
HWE BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	The Mill Disposable - Fine	2012-11-28
PMN K112893 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2011-10-28
PMN K112893 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Duo-Vent	2011-10-28
PMN K112893 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Clearlink	2011-10-28
PMN K112893 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Clearlink Luer Activated Valve	2011-10-28
PMN K111217 | KPE BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Viaflex	2011-07-14
PMN K111217 | KPE BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Aviva	2011-07-14
PMN K111217 | KPE BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Additive Cap	2011-07-14
PMN K101385 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Dual Luer Lock Cap	2011-02-15
PMN K925126 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2009-08-10
PMN K925126 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Duo-Vent	2009-08-10
PMN K925126 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2009-08-10
PMN K880733 | FRN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Anti-Siphon PCA Extension Set	2009-08-08
PMN K880733 | FRN BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Anti-Siphon PCA Combination Set	2009-08-08
PMN K060074 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2007-12-04
PMN K060074 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink System T Connector Ext Se	2007-12-04
PMN K060074 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2007-12-04
PMN K924064 | LHI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2007-12-03
PMN K924064 | LHI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink Universal Vial Adapter	2007-12-03
PMN K924064 | LHI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Clearlink	2007-12-03
PMN K921899 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2007-12-03
PMN K921899 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink System T-Connector ExtSet	2007-12-03
PMN K915390 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2007-12-03
PMN K915390 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	3 Lead Ext w/2 Interlink Inject Sit	2007-12-03
PMN K811078 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Radiation Sterilized Extension Sets	2007-12-03
PMN K811078 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Mini-Infuser	2007-12-03
PMN K811078 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2007-12-03
PMN K811078 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Duo-Vent	2007-12-03
PMN K811078 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Control-A-Flo	2007-12-03
PMN K811078 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2007-12-03
PMN K811078 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Buretrol	2007-12-03
PMN K003225 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Solution Sets w/Capless Luer Valve	2007-12-03
PMN K003225 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2007-12-03
PMN K003225 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Duo-Vent	2007-12-03
PMN K003225 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Control-A-Flo	2007-12-03
PMN K003225 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2007-12-03
PMN K003225 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Clearlink	2007-12-03
PMN K003225 | FPA BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Buretrol	2007-12-03
PMN K003225 | FMF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Solution Sets w/Capless Luer Valve	2007-12-03
PMN K003225 | FMF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Interlink	2007-12-03
PMN K003225 | FMF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Duo-Vent	2007-12-03
PMN K003225 | FMF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Control-A-Flo	2007-12-03
PMN K003225 | FMF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Continu-Flo	2007-12-03
PMN K003225 | FMF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Clearlink	2007-12-03
PMN K003225 | FMF BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	Buretrol	2007-12-03
PMN K003730 | LHI BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	CHEMO-AIDE DISPENSING PIN	2007-07-05
HTW BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	1990-01-03
KDD BAXTER HEALTHCARE S.A. [BAXTER HEALTHCARE CORPORATION]	None	1988-12-01

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• 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
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Related Finance Registrations

NCAGE Code	S7564	BAXTER HEALTHCARE S.A.
CAGE Code	S7564	BAXTER HEALTHCARE S.A.
SEC	0001582211	Baxter Healthcare SA of SWITZERLAND

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092975563	Anvers,Belgium -> Charleston, South Carolina	GEARS PARTS AND ACCES HS CODE: 300490	23 PKG
2020092916991	Singapore,Singapore -> Los Angeles, California	DISPOSABLE HOSPITAL SUPPLIES INTRAV	10256 CTN
2020092916991	Singapore,Singapore -> Los Angeles, California	DISPOSABLE HOSPITAL SUPPLIES INTRAV	10256 CTN
2020092916991	Singapore,Singapore -> Los Angeles, California	DISPOSABLE HOSPITAL SUPPLIES INTRAV	10256 CTN
2020092916147	Panama Canal - Caribbean,Panama -> San Juan, Puerto Rico	GENERAL GOODS	150 CTN
2020092924672	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	BICART 1250G	2160 CTN
2020092968754	Stadersand,Federal Republic of Germany -> Savannah, Georgia	POLYPROPYLEN GRANULAT	18 PAL
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092973040	Liverpool,United Kingdom -> Norfolk, Virginia	MEDICAL SUPPLIES	13680 CAS
2020092975567	Anvers,Belgium -> Charleston, South Carolina	GEARS PARTS AND ACCES HS CODE: 300490	23 PKG
20200929107536	Santo Domingo,Dominican Republic -> San Juan, Puerto Rico	4,143 CASES CONTAINING: MEDICAL DEVICES.	4143 PKG