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US Food and Drug Administration (FDA) - Establishment Registration

FDA Registered Companies - Updated May 2006

What is Establishment Registration?

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration.
FDA Registrations
FDA Registrations
FDA Registrations
FDA Registrations


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Establishment Owner/Operator
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL,  US.
Initial Importer;   Specification Developer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
IRVINE,  CA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
MARION,  NC,  US.
Manufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
MCGAW PARK,  IL,  US.
Specification Developer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
MOUNTAIN HOME,  AR,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
MUNDELEIN,  IL,  US.
Remanufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
ONTARIO,  CA,  US.
Repackager/Relabeller;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
PHOENIX,  AZ,  US.
Remanufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
ROUND LAKE,  IL,  US.
Specification Developer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
ROUND LAKE,  IL,  US.
Specification Developer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION OF PUERTO RICO
AIBONITO,  PR,  US.
Manufacturer;   Contract Sterilizer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION OF PUERTO RICO
MARICAO,  PR,  US.
Manufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION OF PUERTO RICO
SAN GERMAN,  PR,  US.
Manufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE S.A.
LESSINES,  BE.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE S.A.
SWINFORD, COUNTY MAYO,  EI.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE S.A.
SINGAPORE,  SN.
Manufacturer;   Contract Sterilizer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE S.A. DOMINICAN REPUBLIC BRANCH
HAINA,  DR.
Manufacturer;   Contract Sterilizer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER LTD.
MARSA,  MT.
Manufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER PRODUCTOS MEDICOS, LTDA.
NO.1-7052 CARTAGO,  CS.
Manufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER SALES & DISTRIBUTION CORP.
GUAYNABO,  PR,  US.
Initial Importer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAY ADVANCED TECHNOLOGIES, LLC
MENLO PARK,  CA,  US.
Contract Manufacturer;  
HILLMAN COMPANY FLUID POWER RESOURCE GROUP, LLC
PITTSBURG,  PA ,  US.
BAY DENTAL DIRECT
BAY CITY,  MI,  US.
Initial Importer;  
BAY DENTAL DIRECT
BAY CITY,  MI ,  US.
BAY MEDICAL CO., INC.
SOUTH SAN FRANCISCO,  CA,  US.
Initial Importer;  
BAY MEDICAL CO., INC.
SOUTH SAN FRANCISCO,  CA ,  US.
BAY MEDICAL SUPPLY CO., INC.
HUNTINGTON STATION,  NY,  US.

BAY MEDICAL SUPPLY CO., INC.
HUNTINGTON STATION,  NY ,  US.
BAY SHORE MEDICAL EQUIPMENT CORP.
BAY SHORE,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BAY SHORE MEDICAL EQUIPMENT CORP.
BAY SHORE,  NY ,  US.
BAY TECHNICAL PRODUCTS, INC.
FREMONT,  CA,  US.
Manufacturer;   Specification Developer;  
BAY TECHNICAL PRODUCTS, INC.
FREMONT,  CA ,  US.
BAY X-RAY, INC.
WALNUT CREEK,  CA,  US.
Initial Importer;  
BAY X-RAY, INC.
WALNUT CREEK,  CA ,  US.
BAYER CORP.
BRIDGEND, SOUTH WALES,  UK.
Manufacturer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER DIAGNOSTICS MFG., LTD.
SWORDS, COUNTY DUBLIN,  EI.
Manufacturer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER DIAGNOSTICS MFG., LTD.
SUDBURY, SUFFOLK,  UK.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE LLC,DIAGNOSTICS DIVISION
ETOBICOKE, ONTARIO,  CA.
Manufacturer;   Specification Developer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
TORONTO, ONTARIO,  CA.
Specification Developer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
BERKELEY,  CA,  US.
Specification Developer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
ELKHART,  IN,  US.
Manufacturer;   Specification Developer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
ELKHART,  IN,  US.
Manufacturer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
INDIANAPOLIS,  IN,  US.
Initial Importer;   Manufacturer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
MISHAWAKA,  IN,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
MORRISTOWN,  NJ,  US.
Initial Importer;   Specification Developer;  
BAYER HEALTHCARE, LLC
MORRISTOWN,  NJ ,  US.
BAYER HEALTHCARE, LLC
NORWOOD,  MA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
BAYER HEALTHCARE, LLC
TARRYTOWN,  NY ,  US.

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Last Modified: 29 April 2006
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