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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
BERKELEY MEDEVICES
RICHMOND,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BERKELEY MEDEVICES
RICHMOND,  CA ,  US.
BERKELEY ORTHOPEDICS LTD.
GOLDTHORPE ROTHERHAM,  UK.
Unregistered Foreign Lister;  
BERKELEY ORTHOPEDICS LTD.
GOLDTHORPE ROTHERHAM,  UK.
BERKELEY PRODUCTS (UK) LTD.
LEEDS,  UK.
Manufacturer;  
BERKELEY PRODUCTS (UK) LTD.
LEEDS,  UK.
BERKLEY INDUSTRIES, LLC
LA MIRADA,  CA,  US.
Repackager/Relabeller;  
BERKLEY INDUSTRIES, LLC
LOS ANGELES,  CA ,  US.
BERKLEY MEDICAL RESOURCES, INC.
UNIONTOWN,  PA,  US.
Contract Manufacturer;   Manufacturer;  
BERKLEY MEDICAL RESOURCES, INC.
UNIONTOWN,  PA ,  US.
BERKLINE LLC
MORRISTOWN,  TN,  US.
Manufacturer;  
BERKLINE LLC
MORRISTOWN,  TN ,  US.
BERKOWITS SCHOOL OF ELECTROLYSIS, INC.
FOREST HILLS,  NY,  US.
Manufacturer;  
BERKOWITS SCHOOL OF ELECTROLYSIS, INC.
FOREST HILLS,  NY ,  US.
BERKSHIRE CO., LTD.
YOKOHAMA, KANAGAWA,  JA.
Specification Developer;  
BERKSHIRE CO., LTD.
YOKOHAMA, KANAGAWA,  JA.
BERLEX, INC.
WAYNE,  NJ,  US.
Initial Importer;  
SCHERING AG
BERLIN,  GM.
BERMAN LABORATORY & HOSPITAL EQUIPMENT, INC.
CONCORD, ONTARIO,  CA.
Unregistered Foreign Lister;  
BERMAN LABORATORY & HOSPITAL EQUIPMENT, INC.
CONCORD, ONTARIO,  CA.
BERMAN PRINTING CO.
CINCINNATI,  OH,  US.
Contract Manufacturer;  
BERMAN PRINTING CO.
CINCINNATI,  OH ,  US.
BERNAFON AG
BERN,  SZ.
Unregistered Foreign Lister;  
BERNAFON AG
BERN,  SZ.
BERNAFON AUSTRALIA PTY. LTD.
FORTITUDE VALLEY QLD,  AS.
Manufacturer;  
WILLIAM DEMANT HOLDINGS, A/S
SMORUM,  DA.
BERNAFON DISTRIBUTION CENTER
THISTED,  DA.
Manufacturer;  
WILLIAM DEMANT HOLDINGS, A/S
SMORUM,  DA.
BERNAFON LTD.
BERN,  SZ.
Manufacturer;   Specification Developer;  
WILLIAM DEMANT HOLDINGS, A/S
SMORUM,  DA.
BERNARD LABORATORIES, INC.
CINCINNATI,  OH,  US.
Repackager/Relabeller;  
BERNARD LABORATORIES, INC.
CINCINNATI,  OH ,  US.
BERNARD SHEAR OPTICIANS, INC.
OWINGS MILLS,  MD,  US.
Initial Importer;  
BERNARD SHEAR OPTICIANS, INC.
OWINGS MILLS,  MD ,  US.
BERND HAGEN
TUTTLINGEN,  GM.
Manufacturer;  
BERND HAGEN
TUTTLINGEN,  GM.
BERND HOLLAND-MORITZ
SOLINGEN, NRW,  GM.
Unregistered Foreign Lister;  
BERND HOLLAND-MORITZ
SOLINGEN, NRW,  GM.
BERNHARD FREY
TUTTLINGEN, BADEN-WURTTEMBERG,  GM.
Manufacturer;  
BERNHARD FREY
TUTTLINGEN, BADEN-WURTTEMBERG,  GM.
BERNHARD LIETZ
TUTTLINGEN,  GM.
Manufacturer;   Specification Developer;  
BERNHARD LIETZ
TUTTLINGEN,  GM.
BERN-JO CORPORATION
CAMDEN,  NJ,  US.
Initial Importer;  
BERN-JO CORPORATION
CAMDEN,  NJ ,  US.
BERNSTEIN AG
PORTA WESTFALICA,  GM.
Manufacturer;  
BERNSTEIN AG
PORTA WESTFALICA,  GM.
BERRETTA MEDICAL, INC.
MONTREAL, QUEBEC,  CA.
Manufacturer;  
BERRETTA MEDICAL, INC.
MONTREAL, QUEBEC,  CA.
BERRING PRECISION BLADES LLC
ROBERTSVILLE,  MO,  US.
Manufacturer;  
BERRING PRECISION BLADES LLC
ROBERTSVILLE,  MO ,  US.
BERSON & ASSOCIATES DISTRIBUTOR
MORGAN HILL,  CA,  US.
Initial Importer;  
BERSON & ASSOCIATES DISTRIBUTOR
MORGAN HILL,  CA ,  US.
BERT CORPORATION LTD.
SHEUN WAN, HONG KONG,  CH.
Manufacturer;  
BERT CORPORATION LTD.
SHEUN WAN, HONG KONG,  CH.
BERT PHILLIPS, INC.
GLADSTONE,  MO,  US.

BERT PHILLIPS, INC.
GLADSTONE,  MO ,  US.
BERTEC CORP.
COLUMBUS,  OH,  US.
Contract Manufacturer;   Manufacturer;  
BERTEC CORP.
COLUMBUS,  OH ,  US.
BERTHOLD DETECTION SYSTEMS GMBH
PFORZHEIM,  GM.
Manufacturer;  
BERTHOLD DETECTION SYSTEMS GMBH
PFORZHEIM,  GM.
BERTHOLD TECHNOLOGIES
BAD WILDBAD,  GM.
Manufacturer;  
BERTHOLD TECHNOLOGIES
BAD WILDBAD,  GM.
BERTHOLD TECHNOLOGIES USA
OAK RIDGE,  TN,  US.
Initial Importer;  
BERTHOLD TECHNOLOGIES
BAD WILDBAD,  GM.
BESCON CO., LTD.
SUNGDONG-GU, SEOUL,  KS.
Contract Manufacturer;   Manufacturer;  
S.M. KANG
SUNGDONG-GU, SEOUL,  KS.
BESGLOVE MEDICARE SDN. BHD.
SELANGOR,  MY.
Manufacturer;  
BESGLOVE MEDICARE SDN. BHD.
SELANGOR,  MY.
BESMED HEALTH BUSINESS CORP.
TAIPEI,  TW.
Manufacturer;  
BESMED HEALTH BUSINESS CORP.
TAIPEI,  TW.
BESMED HEALTH BUSINESS CORP.
UNION CITY,  CA,  US.
Initial Importer;  
BESMED HEALTH BUSINESS CORP.
TAIPEI,  TW.
BESPAK EUROPE LTD.
MILTON KEYNES,  UK.
Contract Manufacturer;  
BESPAK EUROPE LTD.
KING'S LYNN, NORFOLK,  UK.
BEST BROW INDUSTRIES
SIALKOT-4,  PK.
Manufacturer;  
BEST BROW INDUSTRIES
SIALKOT-4,  PK.
BEST BUY TV, LLC.
DORAL,  FL,  US.
Initial Importer;  
BEST BUY TV, LLC.
DORAL,  FL ,  US.
BEST CARE CORP.
ROWLAND HTS.,  CA,  US.
Initial Importer;  
BEST CARE CORP.
ROWLAND HTS.,  CA ,  US.

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Last Modified: 29 April 2006
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