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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
BIRCHBROOK TECHNOLOGIES LLC.
NEW BALTIMORE,  MI,  US.
Specification Developer;   Repackager/Relabeller;  
BIRCHBROOK TECHNOLOGIES LLC.
NEW BALTIMORE,  MI ,  US.
BIRCHWOOD LABORATORIES, INC.
EDEN PRAIRIE,  MN,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BIRCHWOOD LABORATORIES, INC.
EDEN PRAIRIE,  MN ,  US.
BIRCHWOOD MEDICAL EQUIPMENT SALES & SERVICE, INC.
SCHAGHTICOKE,  NY,  US.

BIRCHWOOD MEDICAL EQUIPMENT SALES & SERVICE, INC.
SCHAGHTICOKE,  NY ,  US.
BIRD & CRONIN, INC.
SAINT PAUL,  MN,  US.
Initial Importer;   Manufacturer;  
BIRD & CRONIN, INC.
SAINT PAUL,  MN ,  US.
BIRDSONG MEDICAL DEVICES, INC.
BREWSTER,  NY,  US.
Specification Developer;  
BIRDSONG MEDICAL DEVICES, INC.
BREWSTER,  NY ,  US.
BIRKENSTOCK FOOTPRINT SANDALS, INC.
NOVATO,  CA,  US.
Initial Importer;  
BIRKENSTOCK FOOTPRINT SANDALS, INC.
NOVATO,  CA ,  US.
BIRKOVA PRODUCTS
GOTHENBURG,  NE,  US.
Contract Manufacturer;  
BIRKOVA PRODUCTS
GOTHENBURG,  NE ,  US.
BISBER CORP. SA - ILS INTERGRATED LABORATORY SOLUT
MONTEVIDEO,  UY.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BISBER CORP. SA
MONTEVIDEO,  UY.
BISCO, INC.
SCHAUMBURG,  IL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BISCO, INC.
SCHAUMBURG,  IL ,  US.
BISELLI INSTRUMENTS GMBH & CO. KG
IRNDORF,  GM.
Manufacturer;  
BISELLI INSTRUMENTS GMBH & CO. KG
IRNDORF,  GM.
BISICO GMBH & CO KG
BIELEFELD,  GM.
Manufacturer;  
BISICO GMBH & CO KG
BIELEFELD,  GM.
BISON-LEE CO.
MESA,  AZ,  US.
Specification Developer;   Repackager/Relabeller;  
BISON-LEE CO.
MESA,  AZ ,  US.
BI-STATE MEDICAL CO. OF KANSAS, INC.
KANSAS CITY,  MO,  US.

BI-STATE MEDICAL CO. OF KANSAS, INC.
KANSAS CITY,  MO ,  US.
BISTOS CO., LTD.
SEOUL,  KS.
Manufacturer;  
BISTOS CO., LTD.
SEOUL,  KS.
BIT DI DE TOFFOL TIZIANO & C. SNC
BELLUNO,  IT.
Manufacturer;  
BIT DI DE TOFFOL TIZIANO & C. SNC
BELLUNO,  IT.
BITE FOOTWEAR
REDMOND,  WA,  US.
Manufacturer;   Specification Developer;  
BITE FOOTWEAR
REDMOND,  WA ,  US.
BITEMASTER
COCOLALLA,  ID,  US.
Manufacturer;  
BITEMASTER
COCOLALLA,  ID ,  US.
BITEX PRIM SRL
SOFIA,  BU.
Repackager/Relabeller;  
BITEX PRIM SRL
SOFIA,  BU.
BITKOEUL HWANG-TO BED CO., LTD.
INCHEON CITY,  KS.
Manufacturer;  
BITKOEUL HWANG-TO BED CO., LTD.
INCHEON CITY,  KS.
BIZFIELD TECHNOLOGIES
LEWIS CENTER,  OH,  US.
Initial Importer;  
BIZFIELD TECHNOLOGIES
LEWIS CENTER,  OH ,  US.
BJ GLOBAL DIRECT, INC.
IRVINE,  CA,  US.
Initial Importer;  
BJ GLOBAL DIRECT, INC.
IRVINE,  CA ,  US.
BJORN EYEWEAR INC.
SAN FRANCISCO,  CA,  US.
Initial Importer;  
BJORN EYEWEAR INC.
SAN FRANCISCO,  CA ,  US.
BK COMPUTER
TENAFLY,  NJ,  US.
Manufacturer;  
BK COMPUTER
TENAFLY,  NJ ,  US.
BK CORP.
CALCUTTA 700029,  IN.
Manufacturer;  
BK CORP.
CALCUTTA 700029,  IN.
BK FRAMES CORPORATION
MIAMI,  FL,  US.
Initial Importer;  
BK FRAMES CORPORATION
MIAMI,  FL ,  US.
B-K MEDICAL APS
HERLEV,  DA.
Manufacturer;  
B-K MEDICAL APS
HERLEV,  DA.
BK MEDITECH CO., LTD.
HWASUNG-SI, KYUNGGI-DO,  KS.
Manufacturer;  
BK MEDITECH CO., LTD.
HWASUNG-SI, KYUNGGI-DO,  KS.
BKG OPTHALMICS USA, INC.
GOLETA,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
BKG OPTHALMICS USA, INC.
GOLETA,  CA ,  US.
BL HEALTHCARE, INC.
FOXBORO,  MA,  US.
Manufacturer;   Specification Developer;  
BL HEALTHCARE, INC.
FOXBORO,  MA ,  US.
BL INDUSTRIA OTICA, LTDA
PORTO ALEGRE, RS,  BR.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
BLACK BEAR MEDICAL, INC.
PORTLAND,  ME,  US.
Initial Importer;  
BLACK BEAR MEDICAL, INC.
PORTLAND,  ME ,  US.
BLACK TIE MEDICAL, INC.
SAN DIEGO,  CA,  US.
Repackager/Relabeller;  
BLACK TIE MEDICAL, INC.
SAN DIEGO,  CA ,  US.
BLACKBERRY TECHNOLOGIES, INC.
POTTSTOWN,  PA,  US.
Manufacturer;  
BLACKBERRY TECHNOLOGIES, INC.
POTTSTOWN,  PA ,  US.
BLACKHAWK BIOSYSTEMS, INC.
SAN RAMON,  CA,  US.
Manufacturer;  
BLACKHAWK BIOSYSTEMS, INC.
SAN RAMON,  CA ,  US.
BLACKLOCK MEDICAL PRODUCTS, INC.
DELTA,  CA.
Manufacturer;  
BLACKLOCK MEDICAL PRODUCTS, INC.
DELTA,  CA.
BLACKSTONE MEDICAL, INC.
SPRINGFIELD,  MA,  US.
Manufacturer;   Specification Developer;  
BLACKSTONE MEDICAL, INC.
SPRINGFIELD,  MA ,  US.
BLACKSTONE MEDICAL, INC.
WAYNE,  NJ,  US.
Specification Developer;  
BLACKSTONE MEDICAL, INC.
SPRINGFIELD,  MA ,  US.
BLACKWOOD MEDICAL INC.
MT. LAUREL,  NJ,  US.
Initial Importer;  
BLACKWOOD MEDICAL INC.
MT. LAUREL,  NJ ,  US.
BLADE TECH S.A. DE C.V.
BAJA CALIFORNIA,  MX.
Manufacturer;  
BLADE TECH S.A. DE C.V.
BAJA CALIFORNIA,  MX.
BLADEZ HEALTH PRODUCTS CORPORATION
FOOTHILL RANCH,  CA,  US.
Initial Importer;  
BLADEZ HEALTH PRODUCTS CORPORATION
FOOTHILL RANCH,  CA ,  US.

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Last Modified: 29 April 2006
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