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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
BONTA IMPORTS LLC
NEW YORK,  NY,  US.
Initial Importer;  
BONTA IMPORTS LLC
NEW YORK,  NY ,  US.
BONTEMPI CHIRURGISCHE INSTRUMENTE OHG
TUTTLINGEN,  GM.
Manufacturer;  
BONTEMPI CHIRURGISCHE INSTRUMENTE OHG
TUTTLINGEN,  GM.
BONUS ENT. CORP.
SAN FRANCISCO,  CA,  US.
Initial Importer;  
BONUS ENT. CORP.
SAN FRANCISCO,  CA ,  US.
BONUTTI RESEARCH, INC.
EFFINGHAM,  IL,  US.
Manufacturer;   Specification Developer;  
BONUTTI RESEARCH, INC.
EFFINGHAM,  IL ,  US.
BONYF AG
VADUZ,  LS.
Manufacturer;  
BONYF AG
VADUZ,  LS.
BOO IL ENT.
BUK-KU,DAEGU,  KS.
Unregistered Foreign Lister;  
BOO IL ENT.
BUK-KU,DAEGU,  KS.
BOO KWANG PRECISION CO.
DAEGU,  KS.
Manufacturer;  
BOO KWANG PRECISION CO.
DAEGU,  KS.
BOO-DA-BEE
LANCASTER,  OH,  US.
Initial Importer;   Repackager/Relabeller;  
BOO-DA-BEE
LANCASTER,  OH ,  US.
BOOKS ARE FUN LTD.
FAIRFIELD,  IA,  US.
Initial Importer;  
BOOKS ARE FUN LTD.
FAIRFIELD,  IA ,  US.
BOONE CENTER, INC.
ST. PETERS,  MO,  US.
Repackager/Relabeller;  
BOONE CENTER, INC.
ST. PETERS,  MO ,  US.
BOOS DENTAL LAB
MINNEAPOLIS,  MN,  US.
Initial Importer;   Manufacturer;  
SENTAGE CORPORATION
MINNEAPOLIS,  MN ,  US.
BOOST TECHNOLOGY, LLC
SAN FRANCISCO,  CA,  US.
Manufacturer;  
BOOST TECHNOLOGY, LLC
SAN FRANCISCO,  CA ,  US.
BORA OPTICAL CO., LTD.
DAEGU CITY,  KS.
Manufacturer;  
BORA OPTICAL CO., LTD.
DAEGU CITY,  KS.
BORDA PRODUCTS, INC.
BRONX,  NY,  US.
Initial Importer;  
BORDA PRODUCTS, INC.
BRONX,  NY ,  US.
BORDER OPPORTUNITY SAVER SYSTEMS, INC.
DEL RIO,  TX,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
BORDER OPPORTUNITY SAVER SYSTEMS, INC.
DEL RIO,  TX ,  US.
BOREL ENTERPRISES LLC
LAKE CHARLES,  LA,  US.
Manufacturer;  
BOREL ENTERPRISES LLC
LAKE CHARLES,  LA ,  US.
BORGATTA
COL. FEDERAL, MEXICO CITY,  MX.
Unregistered Foreign Lister;  
BORGATTA
COL. FEDERAL, MEXICO CITY,  MX.
BORGATTA INGENIERIA APLICADA
COLONIA FEDERAL,  MX.
Unregistered Foreign Lister;  
BORGATTA INGENIERIA APLICADA
COLONIA FEDERAL,  MX.
BORICUA DE LLANOS INC.
SAN JUAN,  PR,  US.
Initial Importer;  
BORICUA DE LLANOS INC.
SAN JUAN,  PR ,  US.
BORRINGIA DANMARK APS
KVISTGAARD,  DA.
Manufacturer;   Specification Developer;  
BORRINGIA DANMARK APS
KVISTGAARD,  DA.
BORRION ENTERPRISE CO., LTD.
TAINAN CITY,  TW.
Manufacturer;  
BORRION ENTERPRISE CO., LTD.
TAINAN CITY,  TW.
BORSCHOW HOSPITAL & MEDICAL SUPPLIES,INC
GUAYNABO,  PR,  US.
Initial Importer;  
BORSCHOW HOSPITAL & MEDICAL SUPPLIES,INC
GUAYNABO,  PR ,  US.
BORSE INDUSTRIES, INC.
WILLOWBROOK,  IL,  US.
Manufacturer;  
BORSE INDUSTRIES, INC.
WILLOWBROOK,  IL ,  US.
BORT MEDICAL
WEINSTADT-BENZACH,  GM.
Foreign Exporter;   Manufacturer;  
BORT MEDICAL
WEINSTADT-BENZACH,  GM.
BORTEC BIOMEDICAL, LTD.
CALGARY, ALBERTA,  CA.
Manufacturer;  
BORTEC BIOMEDICAL, LTD.
CALGARY, ALBERTA,  CA.
BORTEC ELECTRONICS, INC.
CALGARY, ALBERTA,  CA.
Unregistered Foreign Lister;  
BORTEC ELECTRONICS, INC.
CALGARY, ALBERTA,  CA.
BOSL MEDIZINTECHNIK,GMBH
AACHEN,  GM.
Unregistered Foreign Lister;  
BOSL MEDIZINTECHNIK,GMBH
AACHEN,  GM.
BOSMA INDUSTRIES FOR THE BLIND, INC.
INDIANAPOLIS,  IN,  US.
Repackager/Relabeller;  
BOSMA INDUSTRIES FOR THE BLIND, INC.
INDIANAPOLIS,  IN ,  US.
BOSQUE CUSTOM DESIGNS INC.
MERIDIAN,  TX,  US.
Initial Importer;  
BOSQUE CUSTOM DESIGNS INC.
MERIDIAN,  TX ,  US.
BOSS INSTRUMENTS, LTD.
NASHVILLE,  TN,  US.
Repackager/Relabeller;  
BOSS INSTRUMENTS, LTD.
NASHVILLE,  TN ,  US.
BOSS MFG. CO.
KEWANEE,  IL,  US.
Initial Importer;  
BOSS MFG. CO.
KEWANEE,  IL ,  US.
BOSS OPTICAL LENS COMPANY
SHENZHEN, GUANGDONG PROVINCE,  CH.
Remanufacturer;  
BOSS OPTICAL LENS COMPANY
SHENZHEN, GUANGDONG PROVINCE,  CH.
BOSTON BILLOWS, INC.
NASHUA,  NH,  US.
Manufacturer;  
BOSTON BILLOWS, INC.
NASHUA,  NH ,  US.
BOSTON BRACE INTERNATIONAL, INCORPORATED
AVON,  MA,  US.
Manufacturer;  
BOSTON BRACE INTERNATIONAL, INCORPORATED
AVON,  MA ,  US.
BOSTON BRACE INTERNATIONAL, INCORPORATED
MEMPHIS,  TN,  US.
Manufacturer;  
BOSTON BRACE INTERNATIONAL, INCORPORATED
AVON,  MA ,  US.
BOSTON CLUB CO., LTD.
SABAE, FUKUI,  JA.
Manufacturer;  
BOSTON CLUB CO., LTD.
SABAE, FUKUI,  JA.
BOSTON ENDO-SURGICAL TECHNOLOGIES, INC.
HAMPTON,  NH,  US.
Contract Manufacturer;  
BOSTON ENDO-SURGICAL TECHNOLOGIES, INC.
HAMPTON,  NH ,  US.
BOSTON LIFE SCIENCE TRADE GROUP
NEWTONVILLE,  MA,  US.
Initial Importer;  
BOSTON LIFE SCIENCE TRADE GROUP
NEWTONVILLE,  MA ,  US.
BOSTON MEDICAL CORP.
COLUMBIA,  MD,  US.
Contract Manufacturer;  
BOSTON MEDICAL CORP.
COLUMBIA,  MD ,  US.
BOSTON MEDICAL PRODUCTS, INC.
WESTBOROUGH,  MA,  US.
Initial Importer;   Manufacturer;  
BOSTON MEDICAL PRODUCTS, INC.
WESTBOROUGH,  MA ,  US.

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Last Modified: 29 April 2006
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