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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
DIOMED, INC.
ANDOVER,  MA,  US.
Initial Importer;  
DIOMED, INC.
ANDOVER,  MA ,  US.
DIOMED, LTD.
CAMBRIDGE,  UK.
Manufacturer;  
DIOMED, INC.
ANDOVER,  MA ,  US.
DIOMEDEA SRL
PESCARA,  IT.
Foreign Exporter;   Manufacturer;  
DIOMEDEA SRL
PESCARA,  IT.
DIOMEDICS, INC.
MELROSE,  FL,  US.
Manufacturer;  
DIOMEDICS, INC.
MELROSE,  FL ,  US.
DION HEALTH CARE (TAICANG) CO., LTD.
TAICANG, JIANGSU,  CH.
Contract Manufacturer;   Manufacturer;  
DION HEALTH CARE (TAICANG) CO., LTD.
TAICHUNG,  TW.
DIOPSYS INC.
PINE BROOK,  NJ,  US.
Specification Developer;  
DIOPSYS INC.
PINE BROOK,  NJ ,  US.
DIOPTICS MEDICAL PRODUCTS, INC.
SAN LUIS OBISPO,  CA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
DIOPTICS MEDICAL PRODUCTS, INC.
SAN LUIS OBISPO,  CA ,  US.
DIPFORM RUBBER SDN. BHD.
SELANGOR DARUL EHSAN,  MY.
Manufacturer;  
DIPFORM RUBBER SDN. BHD.
SELANGOR DARUL EHSAN,  MY.
DIPPED PRODUCTS (THAILAND) LTD
SONGKHLA,  TH.
Manufacturer;  
DIPPED PRODUCTS (THAILAND) LTD
SONGKHLA,  TH.
DIPPRO SDN. BHD.
SUNGAI PETANI, KEDAH,  MY.
Unregistered Foreign Lister;  
DIPPRO SDN. BHD.
SUNGAI PETANI, KEDAH,  MY.
DIPRODERMA S.A. DE C.V.
TIJUANA, BAJA CALIFORNIA,  MX.
Repackager/Relabeller;  
DIPRODERMA S.A. DE C.V.
TIJUANA, BAJA CALIFORNIA,  MX.
DIPTECH INDUSTRIES SDN. BHD.
BAKAR ARANG,SUNGAI PETANI KEDA,  MY.
Unregistered Foreign Lister;  
DIPTECH INDUSTRIES SDN. BHD.
BAKAR ARANG,SUNGAI PETANI KEDA,  MY.
DIRECT ADVANTAGE VALUES ENT., INC.
SOUTH SAN FRANCISCO,  CA,  US.
Initial Importer;  
D.A.V.E., INC.
SOUTH SAN FRANCISCO,  CA ,  US.
DIRECT CONNECTION LTD.
TAO-YUAN HSIEN,  TW.
Manufacturer;  
DIRECT CONNECTION LTD.
TAIPEI,  TW.
DIRECT DENTAL SUPPLIES INC.
BROOKLYN,  NY,  US.
Initial Importer;  
DIRECT DENTAL SUPPLIES INC.
BROOKLYN,  NY ,  US.
DIRECT DENTAL SUPPLY
SHELTON,  CT,  US.
Initial Importer;   Repackager/Relabeller;  
DIRECT DENTAL SUPPLY
SHELTON,  CT ,  US.
DIRECT DENTAL SUPPLY, INC.
DANVERS,  MA,  US.
Initial Importer;  
DIRECT DENTAL SUPPLY, INC.
DANVERS,  MA ,  US.
DIRECT INDUSTRIES, INC.
TANGENT,  OR,  US.
Specification Developer;  
DIRECT INDUSTRIES, INC.
TANGENT,  OR ,  US.
DIRECT MARKETING ENTERPRISES, LTD.
WESTBURY,  NY,  US.
Initial Importer;  
DIRECT MARKETING ENTERPRISES, LTD.
WESTBURY,  NY ,  US.
DIRECT MEDICAL SUPPLIES, LLC
MEMPHIS,  TN,  US.
Initial Importer;  
DIRECT MEDICAL SUPPLIES, LLC
MEMPHIS,  TN ,  US.
DIRECT MEDICAL SYSTEMS
SAN RAMON,  CA,  US.
Initial Importer;  
DIRECT MEDICAL SYSTEMS
SAN RAMON,  CA ,  US.
DIRECT RADIOGRAPHY CORP.
NEWARK,  DE,  US.
Manufacturer;  
HOLOGIC, INC.
BEDFORD,  MA ,  US.
DIRECT RESOURCE, INC.
COLUMBUS,  OH,  US.
Initial Importer;  
DIRECT RESOURCE, INC.
COLUMBUS,  OH ,  US.
DIRECT SOURCE INTL.
CINCINNATI,  OH,  US.
Initial Importer;  
DIRECT SOURCE INTL.
CINCINNATI,  OH ,  US.
DIRECT SUPPLY EQUIPMENT
MILWAUKEE,  WI,  US.
Initial Importer;  
DIRECT SUPPLY, INC.
MILWAUKEE,  WI ,  US.
DIRECT TRANSPORT PRODUCTS
MIAMI,  FL,  US.
Initial Importer;  
DIRECT TRANSPORT PRODUCTS
MIAMI,  FL ,  US.
DIRECTA AB
UPPLANDS VAESBY,  SW.
Manufacturer;  
DIRECTA AB
UPPLANDS VASBY,  SW.
DIRECTA DENTAL AB
UPPLANDS VASBY,  SW.
Manufacturer;  
DIRECTA AB
UPPLANDS VASBY,  SW.
DIRECTION TECHNOLOGY
SAN CHUNG, TAIPEI,  TW.
Unregistered Foreign Lister;  
DIRECTION TECHNOLOGY
SAN CHUNG, TAIPEI,  TW.
DIRECTION TECHNOLOGY CO. LTD.
SAN CHUNG TAIPEI,  TW.
Manufacturer;  
DIRECTION TECHNOLOGY CO. LTD.
SAN CHUNG TAIPEI,  TW.
DIRECTMED, INC.
GLEN COVE,  NY,  US.
Initial Importer;  
DIRECTMED, INC.
GLEN COVE,  NY ,  US.
DIREX SYSTEMS CORP.
CANTON,  MA,  US.
Manufacturer;  
DIREX SYSTEMS CORP.
CANTON,  MA ,  US.
DIROS TECHNOLOGY, INC.
MARKHAM, ONTARIO,  CA.
Manufacturer;  
DIROS TECHNOLOGY, INC.
MARKHAM, ONTARIO,  CA.
DIRTY DOG EYEWEAR, LTD.
PONSONBY, AUCKLAND,  NZ.
Unregistered Foreign Lister;  
DIRTY DOG EYEWEAR, LTD.
PONSONBY, AUCKLAND,  NZ.
DIRUI INDUSTRIAL CO., LTD.
CHANGCHUN,  CH.
Manufacturer;  
DIRUI INDUSTRIAL CO., LTD.
CHANG CHUN,  CH.
DISC ORTHOPAEDIC TECHNOLOGIES INC.
MONROE TOWNSHIP,  NJ,  US.
Initial Importer;  
DISC ORTHOPAEDIC TECHNOLOGIES, INC.
MONROE TOWNSHIP,  NJ ,  US.
DISC ORTHOPAEDIC TECHNOLOGIES, INC.
PLAINSBORO,  NJ,  US.
Manufacturer;  
DISC ORTHOPAEDIC TECHNOLOGIES, INC.
MONROE TOWNSHIP,  NJ ,  US.
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
HERZLIYA,  IS.
Manufacturer;  
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
HERZLIYA,  IS.
DISCOUNT DISPOSABLES
HAMILTON CITY,  CA,  US.
Initial Importer;  
DISCOUNT DISPOSABLES
HAMILTON CITY,  CA ,  US.
DISCOUNT DME
ANAHEIM,  CA,  US.
Manufacturer;  
DISCOUNT DME
ANAHEIM,  CA ,  US.

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Last Modified: 29 April 2006
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