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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
BARRIER EYEWEAR
LAKE PARK,  FL,  US.
Manufacturer;  
BARRIER EYEWEAR
LAKE PARK,  FL ,  US.
BARRIER MED (THAILAND) CO., LTD.
KLONG LAUNG , PATHUMTHANI,  TH.
Foreign Exporter;  
BARRIER MED (THAILAND) CO., LTD.
KLONG LAUNG , PATHUMTHANI,  TH.
BARRIER TECHNOLOGIES
SAN DIEGO,  CA,  US.
Initial Importer;  
BARRIER TECHNOLOGIES
SAN DIEGO,  CA ,  US.
BARRIERMED GLOVE CO.
LAKE MARY,  FL,  US.
Initial Importer;   Specification Developer;  
BARRIERMED GLOVE CO.
LAKE MARY,  FL ,  US.
BARRINGTON HEALTHCARE INTERNATIONAL, LTD.
LONDON,  UK.
Manufacturer;   Specification Developer;  
BARRINGTON HEALTHCARE INTERNATIONAL, LTD.
LONDON,  UK.
BARRINGTON VENTURES, LTD.
LAKE BARRINGTON,  IL,  US.
Initial Importer;  
BARRINGTON VENTURES, LTD.
LAKE BARRINGTON,  IL ,  US.
BARRON PRECISION INSTRUMENTS, L.L.C.
GRAND BLANC,  MI,  US.
Manufacturer;  
BARRON PRECISION INSTRUMENTS, L.L.C.
GRAND BLANC,  MI ,  US.
BARRX MEDICAL, INCORPORATED
SUNNYVALE,  CA,  US.
Manufacturer;  
BARRX MEDICAL, INCORPORATED
SUNNYVALE,  CA ,  US.
BARRY J. KAPLAN, INC.
SAN DIEGO,  CA,  US.
Repackager/Relabeller;  
BARRY J. KAPLAN, INC.
SAN DIEGO,  CA ,  US.
BAR-S MACHINE, INC.
CHINO VALLEY,  AZ,  US.
Contract Manufacturer;  
BAR-S MACHINE, INC.
CHINO VALLEY,  AZ ,  US.
BART MONGIELLO
NEW PROVIDENCE,  NJ,  US.
Initial Importer;  
BART MONGIELLO
NEW PROVIDENCE,  NJ ,  US.
BARTH DENTAL LAB
INDIANAPOLIS,  IN,  US.
Initial Importer;  
BARTH DENTAL LAB
INDIANAPOLIS,  IN ,  US.
BARTON MEDICAL CORP.
AUSTIN,  TX,  US.
Initial Importer;   Specification Developer;  
BARTON MEDICAL CORP.
AUSTIN,  TX ,  US.
BARTON NELSON, INC.
KANSAS CITY,  MO,  US.
Initial Importer;   Repackager/Relabeller;  
BARTON NELSON, INC.
KANSAS CITY,  MO ,  US.
BARTON-CAREY MEDICAL PRODUCTS, INC.
JELLICO,  TN,  US.
Manufacturer;  
BARTON-CAREY MEDICAL PRODUCTS, INC.
MAUMEE,  OH ,  US.
BARTON-CAREY MEDICAL PRODUCTS, INC.
MAUMEE,  OH,  US.
Manufacturer;  
BARTON-CAREY MEDICAL PRODUCTS, INC.
MAUMEE,  OH ,  US.
BARTOR PHARMACAL CO., INC.
RYE,  NY,  US.
Initial Importer;  
BARTOR PHARMACAL CO., INC.
RYE,  NY ,  US.
BARUFFALDI GERIKON SRL
MILANO,  IT.
Remanufacturer;  
BARUFFALDI GERIKON SRL
MILANO,  IT.
BAS OPTEK
WEST LAFAYETTE,  IN,  US.
Contract Manufacturer;   Manufacturer;  
BAS OPTEK
WEST LAFAYETTE,  IN ,  US.
BASBA INC.
CITY OF INDUSTRY,  CA,  US.
Specification Developer;  
BASBA INC.
CITY OF INDUSTRY,  CA ,  US.
BASE4 GROUP LTD.
DALLAS,  TX,  US.
Initial Importer;  
BASE4 GROUP LTD.
DALLAS,  TX ,  US.
BASHIR JAMIL & BROTHERS (PVT.), LTD.
SIALKOT, PUNJAB,  PK.
Manufacturer;  
BASHIR JAMIL & BROTHERS (PVT.), LTD.
SIALKOT, PUNJAB,  PK.
BASHON INDUSTRIAL CO., LTD.
TAINAN HSIEN,  TW.
Manufacturer;  
BASHON INDUSTRIAL CO., LTD.
TAINAN HSIEN,  TW.
BASIC AMERICAN METAL PRODUCTS
FOND DU LAC,  WI,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
GF HEALTH PRODUCTS, INC
ATLANTA,  GA ,  US.
BASIC DENTAL IMPLANT SYSTEMS, INC.
ALBUQUERQUE,  NM,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BASIC DENTAL IMPLANT SYSTEMS, INC.
ALBUQUERQUE,  NM ,  US.
BASIC DENTAL PRODUCTS, INC.
BOYNTON BEACH,  FL,  US.

BASIC DENTAL PRODUCTS, INC.
BOYNTON BEACH,  FL ,  US.
BASIC INTL., INC.
CHINO,  CA,  US.
Initial Importer;  
BASIC INTL., INC.
CHINO,  CA ,  US.
BASIC MEDICAL INDUSTRIES, INC.
CHINO,  CA,  US.
Initial Importer;  
BASIC MEDICAL INDUSTRIES, INC.
CHINO,  CA ,  US.
BASIK, SWIFT & DETERMINED, INC.
CLEVELAND,  OH,  US.
Initial Importer;  
BASIK, SWIFT & DETERMINED, INC.
CLEVELAND,  OH ,  US.
BASKO HEALTHCARE
AMSTERDAM,  NL.
Unregistered Foreign Lister;  
BASKO HEALTHCARE
AMSTERDAM,  NL.
BASS MEDICAL, INC
CHATSWORTH,  CA,  US.
Manufacturer;  
BASS MEDICAL, INC
CHATSWORTH,  CA ,  US.
BASS PRO, INC.
SPRINGFIELD,  MO,  US.
Initial Importer;  
BASS PRO, INC.
SPRINGFIELD,  MO ,  US.
BATCO - BRAZIL
SAO PAULO, SP,  BR.
Manufacturer;  
BATCO - BRAZIL
SAO PAULO, SP,  BR.
BATES INDUSTRIES, LLC.
SOUTH GLENS FALLS,  NY,  US.
Contract Manufacturer;  
BATES INDUSTRIES, LLC.
SOUTH GLENS FALLS,  NY ,  US.
BATESVILLE AMERICAN MFG. CO.
BATESVILLE,  MS,  US.
Contract Manufacturer;  
KIMBALL CORP.
JASPER,  IN ,  US.
BATH ACCESSORIES CO., INC.
HAYWARD,  CA,  US.
Initial Importer;  
BATH ACCESSORIES CO., INC.
HAYWARD,  CA ,  US.
BATHCOSEY INDUSTRY, INC.
TAIPEI,  TW.
Unregistered Foreign Lister;  
BATHCOSEY INDUSTRY, INC.
TAIPEI,  TW.
BATHEASE INC
CLEARWATER,  FL,  US.
Contract Manufacturer;  
BATHEASE INC
PALM HARBOR,  FL ,  US.
BATRIK MEDICAL MFG., INC.
DORVAL, QUEBEC,  CA.
Repackager/Relabeller;  
BATRIK MEDICAL MFG., INC.
DORVAL, QUEBEC,  CA.
BATTERY SPECIALTIES
COSTA MESA,  CA,  US.
Contract Manufacturer;  
BATTERY SPECIALTIES
COSTA MESA,  CA ,  US.

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Last Modified: 29 April 2006
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