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 Number9616848
FEI Number3002669612
NameBAXTER AG
Owner & OperatorBaxalta US Inc.
Contact Address1445 Lawrence Drive
Thousand Oaks CA 91320 US
Official Correspondent
  • Chris Stevenson
  • 1-310-3393706-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressINDUSTRIESTRASSE 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
DeviceDate
Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH
Other Medication2023-04-22
Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH
Other Medication2023-03-28
Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH
Other Medication2022-08-25
Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH
Other Medication2021-04-07
Takeda Pharmaceuticals America, Inc., Baxalta US INC, Baxalta Manufacturing Sarl, Takeda Manufacturing Austria AG, Takeda Manufacturing Singapore Pte. Ltd., Siegfried Hameln GmbH
Other Medication2019-01-08
BAXTER AG [Baxalta US Inc.]
None2016-08-09
BAXTER AG [Baxalta US Inc.]
None2016-08-09
BAXTER AG [Baxalta US Inc.]
None2016-08-09
BAXTER AG [Baxalta US Inc.]
Coseal Spray Set2015-07-22
BAXTER AG [Baxalta US Inc.]
Duploject System2015-07-22
BAXTER AG [Baxalta US Inc.]
Duplocath2015-07-22
BAXTER AG [Baxalta US Inc.]
Duo Set2015-07-22
BAXTER AG [Baxalta US Inc.]
Duo Set A2015-07-22
BAXTER AG [Baxalta US Inc.]
CELSTAT2015-07-22
BAXTER AG [Baxalta US Inc.]
EasySpray & Spray Set for TISSEEL2015-07-22
BAXTER AG [Baxalta US Inc.]
Fibrinotherm2015-07-22

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code0014NBAXTER AG
NCAGE CodeSJ025BAXTER AG
CAGE Code0014NBAXTER AG
CAGE CodeSJ025BAXTER AG
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020081896319Veracruz,Mexico -> Houston, TexasHOT STAMPING FILM - HOT STAMPING FILM HS CODE : 3212.10.0124 BOX
2020072781117Veracruz,Mexico -> Houston, TexasPIGMENTS (INCLUDING METALLIC POWDERS AND FLAK ES) D - HOT STAMPING FILM HS CODE: 3212.10.0111 BOX
2020072526005Anvers,Belgium -> New Orleans, LouisianaMEDICAL EQUIPMENT33 PAL
2020052636467Veracruz,Mexico -> Houston, TexasPIGMENTS (INCLUDING METALLIC POWDERS AND FLAK ES) D - HOT STAMPING FILM HS CODE: 3212.1024 BOX
2020052022540Caucedo,Dominican Republic -> San Juan, Puerto RicoMEDICAL SUPPLIES16 PAL
2020051923417Caucedo,Dominican Republic -> San Juan, Puerto RicoMEDICAL SUPPLIES16 PAL
20200406406Helsingborg,Sweden -> Los Angeles, CaliforniaBICART 1250G58 PKG
202004021815Helsingborg,Sweden -> Savannah, GeorgiaMEDICAL PRODUCTS58 PKG

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