Baxter Ag

FDA Filings

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

FDA Registration(s)

Registration Number	9616848
FEI Number	3002669612
Name	BAXTER AG
Owner & Operator	Baxalta US Inc.
Contact Address	1445 Lawrence Drive Thousand Oaks CA 91320 US
Official Correspondent	Chris Stevenson 1-310-3393706-x
US Agent	Chris Stevenson Baxalta US Inc. 805 4545909 805 4545730 Chris.Stevenson@shire.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	INDUSTRIESTRASSE 67 VIENNA Wien, A1220 AT
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
ADVATE Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH	Other Medication	2023-04-22
ADVATE Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH	Other Medication	2023-03-28
ADVATE Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH	Other Medication	2022-08-25
ADVATE Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH	Other Medication	2021-04-07
ADVATE Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH	Other Medication	2019-01-08
PMN K072894 \| FPA BAXTER AG [Baxalta US Inc.]	None	2016-08-09
PMN K071459 \| FMF BAXTER AG [Baxalta US Inc.]	None	2016-08-09
NEP BAXTER AG [Baxalta US Inc.]	None	2016-08-09
PMN P030039 \| NBE BAXTER AG [Baxalta US Inc.]	Coseal Spray Set	2015-07-22
PMN K973510 \| FMF BAXTER AG [Baxalta US Inc.]	Duploject System	2015-07-22
PMN K973510 \| FMF BAXTER AG [Baxalta US Inc.]	Duplocath	2015-07-22
PMN K973510 \| FMF BAXTER AG [Baxalta US Inc.]	Duo Set	2015-07-22
PMN K973510 \| FMF BAXTER AG [Baxalta US Inc.]	Duo Set A	2015-07-22
PMN K103245 \| FRO BAXTER AG [Baxalta US Inc.]	CELSTAT	2015-07-22
PMN K050495 \| FMF BAXTER AG [Baxalta US Inc.]	EasySpray & Spray Set for TISSEEL	2015-07-22
JRG BAXTER AG [Baxalta US Inc.]	Fibrinotherm	2015-07-22

Similar & Related FDA Registered Companies

BAXTER DIAGNOSTICS, INC.
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 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 (AG)
Takeda Pharmaceuticals America, Inc.
Baxalta US INC
Baxalta Manufacturing Sarl
Takeda Manufacturing Austria AG
Takeda Manufacturing Singapore Pte. Ltd.
Siegfried Hameln GmbH

Related Finance Registrations

NCAGE Code	0014N	BAXTER AG
NCAGE Code	SJ025	BAXTER AG
CAGE Code	0014N	BAXTER AG
CAGE Code	SJ025	BAXTER AG

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081896319	Veracruz,Mexico -> Houston, Texas	HOT STAMPING FILM - HOT STAMPING FILM HS CODE : 3212.10.01	24 BOX
2020072781117	Veracruz,Mexico -> Houston, Texas	PIGMENTS (INCLUDING METALLIC POWDERS AND FLAK ES) D - HOT STAMPING FILM HS CODE: 3212.10.01	11 BOX
2020072526005	Anvers,Belgium -> New Orleans, Louisiana	MEDICAL EQUIPMENT	33 PAL
2020052636467	Veracruz,Mexico -> Houston, Texas	PIGMENTS (INCLUDING METALLIC POWDERS AND FLAK ES) D - HOT STAMPING FILM HS CODE: 3212.10	24 BOX
2020052022540	Caucedo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL SUPPLIES	16 PAL
2020051923417	Caucedo,Dominican Republic -> San Juan, Puerto Rico	MEDICAL SUPPLIES	16 PAL
20200406406	Helsingborg,Sweden -> Los Angeles, California	BICART 1250G	58 PKG
202004021815	Helsingborg,Sweden -> Savannah, Georgia	MEDICAL PRODUCTS	58 PKG