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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
BLUE COVE CORP.
WILMINGTON,  DE,  US.
Initial Importer;  
BLUE COVE CORP.
WILMINGTON,  DE ,  US.
BLUE CROSS BIO-MEDICAL CO., LTD.
BEIJING,  CH.
Contract Manufacturer;  
BLUE CROSS BIO-MEDICAL CO., LTD.
BEIJING,  CH.
BLUE DIAMOND MANAGEMENT LTD.
VANCOUVER, B.C.,  CA.
Unregistered Foreign Lister;  
BLUE DIAMOND MANAGEMENT LTD.
VANCOUVER, B.C.,  CA.
BLUE DOT PROPERTIES 557(PTY) LTD
WESTERN CAPE,  SF.
Manufacturer;   Specification Developer;  
BLUE DOT PROPERTIES 557(PTY) LTD
WESTERN CAPE,  SF.
BLUE GEM SUNGLASSES, INC.
CARPINTERIA,  CA,  US.
Initial Importer;  
BLUE GEM SUNGLASSES, INC.
CARPINTERIA,  CA ,  US.
BLUE LABEL TECHNOLOGY, INC.
ALBANY,  GA,  US.
Initial Importer;  
BLUE LABEL TECHNOLOGY, INC.
ALBANY,  GA ,  US.
BLUE MEDICAL CO., LTD
SUNGNAM-CITY, KYONGKI-DO,  KS.
Manufacturer;  
BLUE MEDICAL CO., LTD
SUNGNAM-CITY, KYONGKI-DO,  KS.
BLUE SKIES TRADING CO.
ORLANDO,  FL,  US.
Initial Importer;  
BLUE SKIES TRADING CO.
ORLANDO,  FL ,  US.
BLUE SKY BIO, LLC
GRAYSLAKE,  IL,  US.
Manufacturer;   Specification Developer;  
BLUE SKY BIO, LLC
GRAYSLAKE,  IL ,  US.
BLUE SKY INTERNATIONAL TRADING INC.
ORLANDO,  FL,  US.
Initial Importer;  
BLUE SKY INTERNATIONAL TRADING INC.
ORLANDO,  FL ,  US.
BLUE SKY MEDICAL GROUP INCORPORATED
CARLSBAD,  CA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BLUE SKY MEDICAL GROUP INCORPORATED
CARLSBAD,  CA ,  US.
BLUE SKY MEDICAL SUPPLIES, INC.
SAN GABRIEL,  CA,  US.
Initial Importer;  
BLUE SKY MEDICAL SUPPLIES, INC.
SAN GABRIEL,  CA ,  US.
BLUE SKY TRADING CO., INC.
BINONDO, MANILA,  RP.
Manufacturer;  
BLUE SKY TRADING CO., INC.
BINONDO, MANILA,  RP.
BLUE SKY TRADING INC.
BAYONNE,  NJ,  US.
Initial Importer;  
BLUE SKY TRADING INC.
BAYONNE,  NJ ,  US.
BLUE SPRING CORP.
PORT LAVACA,  TX,  US.
Manufacturer;  
BLUE SPRING CORP.
PORT LAVACA,  TX ,  US.
BLUE STAR IMPORTS L.P.
WARRENDALE,  PA,  US.
Initial Importer;  
BLUE STAR IMPORTS L.P.
WARRENDALE,  PA ,  US.
BLUE STREAM INTL.
SIALKOT,  PK.
Manufacturer;  
BLUE STREAM INTL.
SIALKOT,  PK.
BLUE TORCH MEDICAL TECHNOLOGIES
ASHLAND,  MA,  US.
Manufacturer;   Specification Developer;  
BLUE TORCH MEDICAL TECHNOLOGIES
ASHLAND,  MA ,  US.
BLUE X IMAGING SRL
ASSAGO,(MI),  IT.
Manufacturer;  
BLUE X IMAGING SRL
ASSAGO, MILAN,  IT.
BLUE.S4 INC.
TORONTO, ONTARIO,  CA.
Manufacturer;  
BLUE.S4 INC.
TORONTO, ONTARIO,  CA.
BLUEAIR AB
STOCKHOLM,  SW.
Manufacturer;  
BLUEAIR INC.
CHICAGO,  IL ,  US.
BLUEPATH INDUSTRIES LTD
EDMONTON, ALBERTA,  CA.
Manufacturer;  
BLUEPATH INDUSTRIES LTD
EDMONTON, ALBERTA,  CA.
BLUESONIC CORPORATION
SEOUL,  KS.
Manufacturer;  
BLUESONIC CORPORATION
SEOUL,  KS.
BLV LICHT-UND VAKUUMTECHNIK GMBH
STEINHORING,  GM.
Manufacturer;  
BLV LICHT-UND VAKUUMTECHNIK GMBH
STEINHORING,  GM.
BM BROWNE UK LTD. BROWNES GU
READING BERKS,  UK.
Manufacturer;  
BM BROWNE UK LTD. BROWNES GU
READING BERKS,  UK.
BMC INDUSTRIES
ST. CLOUD,  MN,  US.
Manufacturer;  
BMC INDUSTRIES
MINNEAPOLIS,  MN ,  US.
BMG MARKETING & CONSULTING, INC.
FULLERTON,  CA,  US.
Initial Importer;  
BMG MARKETING & CONSULTING, INC.
FULLERTON,  CA ,  US.
BMK
CARROLLTON,  TX,  US.
Initial Importer;  
BMK
CARROLLTON,  TX ,  US.
BMP TECHNOLOGIES, INC.
COLLINGWOOD, ONTARIO,  CA.
Manufacturer;  
BMP TECHNOLOGIES, INC.
COLLINGWOOD, ONTARIO,  CA.
BMS ENTERPRISES
MISSISSAUGA, ONTARIO,  CA.
Repackager/Relabeller;  
1066259 ONTARIO LIMITED
MISSISSAUGA, ONTARIO,  CA.
BMV OPTICAL, INC.
FORT LEE,  NJ,  US.
Initial Importer;  
BMV OPTICAL, INC.
FORT LEE,  NJ ,  US.
BMW OF NORTH AMERICA LLC
WOODCLIFF LAKE,  NJ,  US.
Initial Importer;  
BMW OF NORTH AMERICA LLC
WOODCLIFF LAKE,  NJ ,  US.
BMW OF NORTH AMERICA, LLC
MOUNT OLIVE,  NJ,  US.
Initial Importer;  
BMW AG
MUNICH,  GM.
BMW PRECISION MACHINING, INC.
OCEANSIDE,  CA,  US.
Contract Manufacturer;  
BMW PRECISION MACHINING, INC.
OCEANSIDE,  CA ,  US.
BMZ INTERNATIONAL CORP.
HIALEAH,  FL,  US.
Initial Importer;  
BMZ INTERNATIONAL CORP.
HIALEAH,  FL ,  US.
BNH INTERNATIONAL, INC.
ENGLEWOOD CLIFFS,  NJ,  US.
Initial Importer;  
BNH INTERNATIONAL, INC.
ENGLEWOOD CLIFFS,  NJ ,  US.
BNL EUROLENS
BELLEGARDE,  FR.
Manufacturer;  
BNL EUROLENS
BELLEGARDE,  FR.
BNOS MEDITECH, LTD.
ESSEX,  UK.
Unregistered Foreign Lister;  
BNOS MEDITECH, LTD.
ESSEX,  UK.
BNP IMPORTS, INC.
HOUSTON,  TX,  US.
Initial Importer;  
BNP IMPORTS, INC.
HOUSTON,  TX ,  US.
BNT CO, INC.
LAKELAND,  FL,  US.
Initial Importer;  
BNT CO, INC.
LAKELAND,  FL ,  US.

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Last Modified: 29 April 2006
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