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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
BOHYA INTERNATIONAL CO., LTD.
TAIPEI,  TW.
Manufacturer;  
BOHYA INTERNATIONAL CO., LTD.
TAIPEI,  TW.
BOIN MEDICA CO. LTD.
SEOUL, CHUNG-KU,  KS.
Manufacturer;  
BOIN MEDICA CO. LTD.
SEOUL,  KS.
BOISE CASCADE OFFICE PRODUCTS CORP.
HONOLULU,  HI,  US.
Initial Importer;  
BOISE OFFICE SOLUTIONS
ITASCA,  IL ,  US.
BOLAN TRADERS
SIALKOT, PUNJAB,  PK.
Manufacturer;  
BOLAN TRADERS
SIALKOT, PUNJAB,  PK.
BOLLE
OYONNAX CEDEX,  FR.
Manufacturer;  
BUSHNELL PERFORMANCE OPTICS
OVERLAND PARK,  KS ,  US.
BOLLE AMERICA
OVERLAND PARK,  KS,  US.
Initial Importer;  
BOLLE AMERICA
OVERLAND PARK,  KS ,  US.
BOLLE JAPAN
OSAKA CITY,  JA.
Manufacturer;  
BOLLE JAPAN
OSAKA CITY,  JA.
BOLLMAN HAT COMPANY
ADAMSTOWN,  PA,  US.
Initial Importer;  
BOLLMAN HAT COMPANY
ADAMSTOWN,  PA ,  US.
BOLLORE, INC.
DAYVILLE,  CT,  US.
Initial Importer;   Repackager/Relabeller;  
BOLLORE, INC.
DAYVILLE,  CT ,  US.
BOLT BETHEL LLC.
BETHEL,  MN,  US.
Contract Manufacturer;  
BOLT INDUSTRIES LLC.
BALTIMORE,  MD ,  US.
BOLTON MEDICAL, INC.
SUNRISE,  FL,  US.
Manufacturer;  
BOLTON MEDICAL, INC.
SUNRISE,  FL ,  US.
BOM SENSO DESCARTAVEIS HOSPITALARES LTDA
INTERLAGOS, SAO PAULO,  BR.
Manufacturer;  
BOM SENSO DESCARTAVEIS HOSPITALARES LTDA
INTERLAGOS, SAO PAULO,  BR.
BOMAR INDUSTRIES
INDIANAPOLIS,  IN,  US.
Contract Manufacturer;  
BOMAR INDUSTRIES
INDIANAPOLIS,  IN ,  US.
BOMIMED INC.
WINNIPEG, MANITOBA,  CA.
Foreign Exporter;   Repackager/Relabeller;  
BOMIMED INC.
WINNIPEG, MANITOBA,  CA.
BOMMER AG
ZURICH,  SZ.
Manufacturer;  
BOMMER AG
ZURICH,  SZ.
BOMYL OPTICAL MANUFACTORY LIMITED
GUANG DONG,  CH.
Manufacturer;  
BOMYL OPTICAL MANUFACTORY LIMITED
N.T.,  HK.
BON ROUX (PTY) LTD
MORELETAPARK PRETORIA,  SF.
Manufacturer;  
BON ROUX (PTY) LTD
MORELETAPARK PRETORIA,  SF.
BON SECOURS HOME MEDICAL, INC.
EAST POINTE,  MI,  US.

BINSON'S HOSPITAL SUPPLIES, INC.
CENTERLINE,  MI ,  US.
BONALYSE OY
JYVASKYLA,  FI.
Manufacturer;  
BONALYSE OY
JYVASKYLA,  FI.
BONART CO. LTD.
HSINCHUANG, TAIPEI,  TW.
Contract Manufacturer;   Manufacturer;  
BONART CO. LTD.
HSINCHUANG, TAIPEI,  TW.
BONART MEDICAL TECHNOLOGY, INC.
WALNUT,  CA,  US.
Initial Importer;  
BONART CO. LTD.
HSINCHUANG, TAIPEI,  TW.
BONASSE ENT. CO., LTD.
LUCHOU CITY,TAIPEI HSIEN,  TW.
Manufacturer;  
BONASSE ENT. CO., LTD.
LUCHOU CITY, TAIPEI HSIEN,  TW.
BONDED LOGISTICS INC
CHARLOTTE,  NC,  US.
Repackager/Relabeller;  
BONDED LOGISTICS INC
CHARLOTTE,  NC ,  US.
BONDED LOGISTICS INC
CHARLOTTE,  NC,  US.
Repackager/Relabeller;  
BONDED LOGISTICS INC
CHARLOTTE,  NC ,  US.
BONDET J.A.
OYONNAX (AIN),  FR.
Unregistered Foreign Lister;  
BONDET J.A.
OYONNAX (AIN),  FR.
BONDFIELD INTERNATIONAL LTD.
FOTAN, SATIN,  HK.
Unregistered Foreign Lister;  
BONDFIELD INTERNATIONAL LTD.
FOTAN, SATIN,  HK.
BONDI BLU USA, LLC
MIAMI,  FL,  US.
Initial Importer;  
BONDI BLU USA, LLC
MIAMI,  FL ,  US.
BONE DENSITY MEASUREMENT INTERNATIONAL, LLC
FREDERICK,  MD,  US.
Manufacturer;  
BONE DENSITY MEASUREMENT INTERNATIONAL, LLC
FREDERICK,  MD ,  US.
BONE FOAM
MINNEAPOLIS,  MN,  US.
Manufacturer;  
BONE FOAM
MINNEAPOLIS,  MN ,  US.
BONECARE IMPLANTS
SIALKOT, PUNJAB,  PK.
Manufacturer;  
BONECARE IMPLANTS
SIALKOT, PUNJAB,  PK.
BONEL MEDICAL EQUIPMENT, INC.
PHILADELPHIA,  PA,  US.
Initial Importer;  
BONEL MEDICAL EQUIPMENT, INC.
PHILADELPHIA,  PA ,  US.
BONGERS
MIDDLETOWN,  CA,  US.
Contract Manufacturer;  
BONGERS
MIDDLETOWN,  CA ,  US.
BONINI S.R.L.
DELEBIO (SO),  IT.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
BONINI S.R.L.
DELEBIO (SO),  IT.
BONITA DENTAL LAB
BONITA SPRINGS,  FL,  US.
Initial Importer;   Manufacturer;  
BONITA DENTAL LAB
BONITA SPRINGS,  FL ,  US.
BONJOUR CO., LTD.
TAIPEI,  TW.
Manufacturer;  
BONJOUR CO., LTD.
TAIPEI,  TW.
BONN EXPORT CORP. (M) SDN. BHD.
PETALING JAYA, SELANGOR DARUL,  MY.
Repackager/Relabeller;  
LIT SENG DEVELOPMENT SDN. BHD.
SELANGOR DARUL EHSAN,  MY.
BONNE YES ENT.
TAOYUEN,  TW.
Unregistered Foreign Lister;  
BONNE YES ENT.
TAOYUEN,  TW.
BONNEX OPTICAL CORP.
TAIPEI,  TW.
Manufacturer;  
BONNEX OPTICAL CORP.
TAIPEI,  TW.
BONRO MEDICAL, INC
MARTINEZ,  GA,  US.
Initial Importer;  
BONRO MEDICAL, INC
MARTINEZ,  GA ,  US.
BONSO ELECTRONICS INTERNATIONAL INC.
TSIMSHATSUI , KLN,  HK.
Foreign Exporter;   Manufacturer;  
BONSO ELECTRONICS INTERNATIONAL INC.
TSIMSHATSUI , KLN,  HK.

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Last Modified: 29 April 2006
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