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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
BATTLE CREEK MANUFACTURERS, INC.
BATTLE CREEK,  MI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BATTLE CREEK MANUFACTURERS, INC.
BATTLE CREEK,  MI ,  US.
BAUER COMFORT
BROOKLYN,  NY,  US.
Initial Importer;  
BAUER COMFORT
BROOKLYN,  NY ,  US.
BAUERFEIND FUSSORTHOPAEDIE GMBH & CO. KG
REMSCHEID,  GM.
Manufacturer;  
BAUERFEIND AG
ZEULENRODA,  GM.
BAUERFEIND ORTHOPAEDIE GMBH & CO.
KEMPEN,  GM.
Manufacturer;  
BAUERFEIND AG
ZEULENRODA,  GM.
BAUERFEIND PROSTHETICS
KENNESAW,  GA,  US.
Initial Importer;  
BAUERFEIND AG
ZEULENRODA,  GM.
BAUERFEIND PROTHETIK
ZEULENRODA,  GM.
Manufacturer;  
BAUERFEIND AG
ZEULENRODA,  GM.
BAUHINIA LTD.
HONG KONG,  HQ.
Unregistered Foreign Lister;  
BAUHINIA LTD.
HONG KONG,  HQ.
BAUMER S.A.
MOGI MIRIM, SAO PAULO,  BR.
Manufacturer;  
BAUMER S.A.
MOGI MIRIM, SAO PAULO,  BR.
BAUMVISION, LLC
COSTA MESA,  CA,  US.
Initial Importer;   Contract Manufacturer;  
BAUMVISION, LLC
COSTA MESA,  CA ,  US.
BAUR UND HASELBARTH-CHIRURG GMBH
ELLERAU,  GM.
Contract Manufacturer;  
BAUR UND HASELBARTH-CHIRURG GMBH
ELLERAU,  GM.
BAUSCH & LOMB ELC SPL
SCHIPOL RIJK,  NL.
Foreign Exporter;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB GMBH
DORNACH NR. MUNICH,  GM.
Manufacturer;  
BAUSCH & LOMB GMBH
DORNACH NR. MUNICH,  GM.
BAUSCH & LOMB HFD
HOOFDORP,  NL.
Foreign Exporter;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB INCORPORATED
TAMPA,  FL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB IRELAND, LTD.
WATERFORD,  EI.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB SCOTLAND LTD
LIVINGSTON, SCOTLAND,  UK.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB SCOTLAND LTD
LIVINGSTON, SCOTLAND,  UK.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB TECHNOLAS GMBH
FELDKIRCHEN,  GM.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
HEIDELBERG,  GM.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
CLEARWATER,  FL,  US.
Manufacturer;   Specification Developer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
GREENVILLE,  SC,  US.
Initial Importer;   Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
GREENVILLE,  SC,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
LYNCHBURG,  VA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
MANCHESTER,  MO,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
MIAMI,  FL,  US.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
RIO PIEDRAS,  PR,  US.
Initial Importer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
ROCHESTER,  NY,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
ST. LOUIS,  MO,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH & LOMB, INC.
WILMINGTON,  MA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BAUSCH ARTICULATING PAPERS, INC.
NASHUA,  NH,  US.
Initial Importer;  
BAUSCH ARTICULATING PAPERS, INC.
NASHUA,  NH ,  US.
BAWMED UK LTD.
LLANTWIT MAJOR,  UK.
Manufacturer;  
BAWMED UK LTD.
LLANTWIT MAJOR,  UK.
BAXA CORP.
ENGLEWOOD,  CO,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BAXA CORP.
ENGLEWOOD,  CO ,  US.
BAXTER AG
VIENNA,  AU.
Specification Developer;  
BAXTER AG
VIENNA,  AU.
BAXTER CORPORATION
ALLISTON,  CA.
Manufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE
PINELLAS PARK,  FL,  US.
Specification Developer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORP.
LARGO,  FL,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORP.
MEMPHIS,  TN,  US.
Initial Importer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
FREMONT,  CA,  US.
Manufacturer;  
BAXTER HEALTHCARE CORP., BIOSCIENCE
WESTLAKE VILLAGE,  CA ,  US.
BAXTER HEALTHCARE CORPORATION
BUFFALO GROVE,  IL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.
BAXTER HEALTHCARE CORPORATION
CLEVELAND,  MS,  US.
Manufacturer;  
BAXTER HEALTHCARE CORPORATION
DEERFIELD,  IL ,  US.

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Last Modified: 29 April 2006
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