Baxter Healthcare

FDA Filings

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

Baxter Healthcare holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Synergy Health Sterilisation UK Ltd

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K192705 Baxter Healthcare	MiniCap Extended Life PD Transfer Sets	2019-10-25
PMN K152675 BAXTER HEALTHCARE	EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER	2015-10-29

Similar & Related FDA Registered Companies

• BAXTER HEALTHCARE CORPORATION
• Baxter Healthcare Corproration
• Baxter Healthcare Corportation
• BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
• BAXTERHEALTHCARE, INC.
• BAXTER HEALTHCARE CORP., BIOSCIENCE
• 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 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 Healthcare Company
• Baxter Healthcare SA

Related Finance Registrations

NCAGE Code	EX063	BAXTER HEALTHCARE
CAGE Code	EX063	BAXTER HEALTHCARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092953498	Genova,Italy -> Norfolk, Virginia	PHARMACEUTICALS NOT RESTRICTED	36 PCS
2020092953498	Genova,Italy -> Norfolk, Virginia	PHARMACEUTICALS NOT RESTRICTED	36 PCS
2020092829139	Genova,Italy -> New York/Newark Area, Newark, New Jersey	PHOXILLUM BK4/2.5 HS CODE: 30049000 INVOICE 20006198	1480 PKG
202009265892	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	PHYSIONEAL 1.5% DEXTROSE(2L)	64 CTN
20200926188	La Spezia,Italy -> Long Beach, California	PHYSIOLOGICAL SALINE SOLUTION NO PHARMA HS:300490	2960 PKG
20200926188	La Spezia,Italy -> Long Beach, California	PHYSIOLOGICAL SALINE SOLUTION NO PHARMA HS:300490	2960 PKG
2020092517357	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	PHARMA INTRALIPID SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15 TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG
2020092545411	Genova,Italy -> Savannah, Georgia	BICART 1250G HS CODE: 28363000 INVOICE 20006322	2088 CTN
2020092562060	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL DEVICES	3838 CAS
2020092562060	Rio Jaina,Dominican Republic -> Port Everglades, Florida	MEDICAL DEVICES.	3838 CAS
2020092517355	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	PHARMA INTRALIPID SET TEMP PLUS 20 DEGREES CELSIUS RANGE PLUS 15 TO PLUS 25 DEGREES CELSIUS HS-CODE 30049000	46 PKG