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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
BIOLIGHT INTERNATIONAL AB
DANDERYD,  SW.
Manufacturer;  
BIOLIGHT INTERNATIONAL AB
DANDERYD,  SW.
BIOLINE CO., LTD.
GYEONGGI-DO,  KS.
Manufacturer;  
BIOLINE CO., LTD.
GYEONGGI-DO,  KS.
BIOLITEC, INC.
EAST LONGMEADOW,  MA,  US.
Contract Manufacturer;   Manufacturer;  
DR. WOLFGANG NEUBERGER
BONN,  GM.
BIOLOG, INC.
HAYWARD,  CA,  US.
Manufacturer;   Specification Developer;  
BIOLOG, INC.
HAYWARD,  CA ,  US.
BIO-LOGIC SYSTEMS CORP.
MUNDELEIN,  IL,  US.
Manufacturer;  
BIO-LOGIC SYSTEMS CORP.
MUNDELEIN,  IL ,  US.
BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES
TOLEDO,  OH,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Contract Sterilizer;   Repackager/Relabeller;  
BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES
TOLEDO,  OH ,  US.
BIOLOGICAL CONTROLS, INC.
EATONTOWN,  NJ,  US.
Manufacturer;  
BIOLOGICAL CONTROLS, INC.
EATONTOWN,  NJ ,  US.
BIOLOGOS, INC.
MONTGOMERY,  IL,  US.
Contract Manufacturer;   Manufacturer;   Contract Sterilizer;  
BIOLOGOS, INC.
MONTGOMERY,  IL ,  US.
BIO-LOK INTL., INC.
DEERFIELD BEACH,  FL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
BIO-LOK INTL., INC.
DEERFIELD BEACH,  FL ,  US.
BIOLOREN SAS
SARONNO,VARESE,  IT.
Manufacturer;  
BIOLOREN SAS
SARONNO,VARESE,  IT.
BIOLUCENT, INC.
ALISO VIEJO,  CA,  US.
Specification Developer;  
BIOLUCENT, INC.
ALISO VIEJO,  CA ,  US.
BIOMAGNETIC THERAPY SYSTEMS, INC.
MUNICH,  GM.
Manufacturer;  
BIOMAGNETIC THERAPY SYSTEMS, INC.
MUNICH,  GM.
BIOMAGNETIC THERAPY SYSTEMS, INC.
BOCA RATON,  FL,  US.
Initial Importer;  
BIOMAGNETIC THERAPY SYSTEMS, INC.
MUNICH,  GM.
BIOMARK, INC.
PUEBLO,  CO,  US.
Initial Importer;   Manufacturer;  
BIOMARK, INC.
PUEBLO,  CO ,  US.
BIOMAT SCIENCES, INC.
BETHESDA,  MD,  US.
Manufacturer;  
BIOMAT SCIENCES, INC.
BETHESDA,  MD ,  US.
BIOMATERIALS KOREA INC.
SEOUL,  KS.
Manufacturer;  
BIOMATERIALS KOREA INC.
SEOUL,  KS.
BIOMATLANTE
VIGNEUX DE BRETAGNE,  FR.
Manufacturer;  
BIOMATLANTE
VIGNEUX DE BRETAGNE,  FR.
BIOMATRIX (M) SDN. BHD.
SRI PENGKALAN, IPOH, PERAK,  MY.
Contract Manufacturer;   Manufacturer;  
BIOMATRIX (M) SDN. BHD.
IPOH, PERAK,  MY.
BIOMEC, INC.
CLEVELAND,  OH,  US.
Contract Manufacturer;   Manufacturer;  
BIOMEC, INC.
CLEVELAND,  OH ,  US.
BIOMED BROKERS SRL
CIUDAD DE BUENOS AIRES,  AR.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOMED BROKERS SRL
CIUDAD DE BUENOS AIRES,  AR.
BIOMED DEVICES CORP.
FRONT ROYAL,  VA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOMED DEVICES CORP.
FRONT ROYAL,  VA ,  US.
BIO-MED DEVICES, INC.
GUILFORD,  CT,  US.
Manufacturer;  
BIO-MED DEVICES, INC.
GUILFORD,  CT ,  US.
BIO-MED DEVICES, INC.
MADISON,  CT,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIO-MED DEVICES, INC.
GUILFORD,  CT ,  US.
BIOMED DIAGNOSTICS, INC.
WHITE CITY,  OR,  US.
Manufacturer;  
BIOMED DIAGNOSTICS, INC.
WHITE CITY,  OR ,  US.
BIOMED INTL., LLC.
IRVINE,  CA,  US.
Manufacturer;  
BIOMED INTL., LLC.
IRVINE,  CA ,  US.
BIOMED PLASTICS CO.
TAICANG, JIANGSU,  CH.
Manufacturer;  
BIOMED PLASTICS CO.
TAICANG, JIANGSU,  CH.
BIO-MED PLASTICS, INC.
MERRICK,  NY,  US.
Contract Manufacturer;  
BIO-MED PLASTICS, INC.
MERRICK,  NY ,  US.
BIOMED PRODUCTS LLC.
RANCHO CORDOVA,  CA,  US.
Manufacturer;  
BIOMED PRODUCTS LLC.
RANCHO CORDOVA,  CA ,  US.
BIOMED RESOURCE, INC.
HAWTHORNE,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOMED RESOURCE, INC.
HAWTHORNE,  CA ,  US.
BIOMED SYSTEMS, INC.
COPIAGUE,  NY,  US.
Contract Manufacturer;  
JACK KAUFMAN
COPIAGUE,  NY ,  US.
BIO-MED U.S.A., INC.
PATERSON,  NJ,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
BIO-MED U.S.A., INC.
PATERSON,  NJ ,  US.
BIOMEDEX, INC.
SPOKANE,  WA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
BIOMEDEX, INC.
SPOKANE,  WA ,  US.
BIO-MEDIA UNLIMITED, LTD.
WOODBRIDGE, ONTARIO,  CA.
Manufacturer;  
BIO-MEDIA UNLIMITED, LTD.
WOODBRIDGE, ONTARIO,  CA.
BIOMEDICA DIAGNOSTICS INC.
WINSOR, NOVA SCOTIA,  CA.
Manufacturer;  
SURBIACO HOLDING LTD.
WINDSOR, NOVA SCOTIA,  CA.
BIOMEDICAL COMPOSITES, LTD.
VENTURA,  CA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
BIOMEDICAL COMPOSITES, LTD.
VENTURA,  CA ,  US.
BIO-MEDICAL DEVICES, INC.
IRVINE,  CA,  US.
Contract Manufacturer;  
BIO-MEDICAL DEVICES
IRVINE,  CA ,  US.
BIOMEDICAL DIAGNOSTICS (BMD) SA
MARNE LA VALLEE CEDEX 2,  FR.
Manufacturer;  
BIOMEDICAL DIAGNOSTICS (BMD) SA
MARNE LA VALLEE CEDEX 2,  FR.
BIOMEDICAL ELECTRONICS
ARTIGUES-PRES-BORDEAUX,GIRONDE,  FR.
Manufacturer;  
PASCAL LUONG
ARTIGUES-PRES-BORDEAUX,GIRONDE,  FR.
BIOMEDICAL ENT., INC.
SAN ANTONIO,  TX,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BIOMEDICAL ENT., INC.
SAN ANTONIO,  TX ,  US.
BIOMEDICAL EXPORTS, INC.
ASHLAND,  OR,  US.
Initial Importer;  
BIOMEDICAL EXPORTS, INC.
ASHLAND,  OR ,  US.

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Last Modified: 29 April 2006
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