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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
IMAGING ASSOCIATES, INC.
MIAMI,  FL,  US.
Initial Importer;  
IMAGING ASSOCIATES, INC.
MIAMI,  FL ,  US.
IMAGING DIAGNOSTIC SYSTEMS, INC.
PLANTATION,  FL,  US.
Manufacturer;  
IMAGING DIAGNOSTIC SYSTEMS, INC.
PLANTATION,  FL ,  US.
IMAGING DYNAMICS COMPANY LTD.
CALGARY, ALBERTA,  CA.
Manufacturer;  
IMAGING DYNAMICS COMPANY LTD.
CALGARY, ALBERTA,  CA.
IMAGING SCIENCES INTL., INC.
HATFIELD,  PA,  US.
Manufacturer;  
IMAGING SCIENCES INTL., INC.
HATFIELD,  PA ,  US.
IMAGING SCIENCES, LLC
WILLOUGHBY,  OH,  US.
Manufacturer;  
IMAGING SCIENCES, LLC
WILLOUGHBY,  OH ,  US.
IMAGING SYSTEMS & SERVICE INC.
MENTOR,  OH,  US.
Initial Importer;   Contract Manufacturer;  
IMAGING SYSTEMS & SERVICE INC.
MENTOR,  OH ,  US.
IMAGING SYSTEMS INTERNATIONAL, INC.
ANN ARBOR,  MI,  US.
Initial Importer;  
IMAGING SYSTEMS INTERNATIONAL, INC.
ANN ARBOR,  MI ,  US.
IMAGINIQUE EYEWEAR, INC.
MIAMI BEACH,  FL,  US.
Initial Importer;  
IMAGINIQUE EYEWEAR, INC.
MIAMI BEACH,  FL ,  US.
IMAGO GMBH
OBERHACHING,  GM.
Unregistered Foreign Lister;  
IMAGO GMBH
OBERHACHING,  GM.
IMAGO RADIOLOGY S.R.L.
ABBIATEGRASSO (MI),  IT.
Unregistered Foreign Lister;  
IMAGO RADIOLOGY S.R.L.
ABBIATEGRASSO (MI),  IT.
IMAGO THE GERMAN EYEWARE CONNECTION GMBH
VALLEY,  GM.
Foreign Exporter;   Manufacturer;  
IMAGO THE GERMAN EYEWARE CONNECTION GMBH
VALLEY,  GM.
IMAGYN MEDICAL TECHNOLOGIES, INC.
IRVINE,  CA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
IMAGYN MEDICAL TECHNOLOGIES, INC.
IRVINE,  CA ,  US.
IMAK PRODUCTS CORP.
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;  
IMAK PRODUCTS CORP.
SAN DIEGO,  CA ,  US.
IMALUX CORPORATION
CLEVELAND,  OH,  US.
Manufacturer;   Specification Developer;  
IMALUX CORPORATION
CLEVELAND,  OH ,  US.
IMASCOPE INC.
GATINEAU,QUEBEC,  CA.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
IMASCOPE INC.
GATINEAU,QUEBEC,  CA.
I-MAX INTL. CO., LTD.
KAOHSIUNG,  TW.
Manufacturer;  
I-MAX INTL. CO., LTD.
KAOHSIUNG,  TW.
IMC-HEARTWAY, L.L.C.
FORT MYERS,  FL,  US.
Initial Importer;  
IMC-HEARTWAY, L.L.C.
FORT MYERS,  FL ,  US.
IMCO TECHNOLOGIES
PEWAUKEE,  WI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IMCO TECHNOLOGIES
PEWAUKEE,  WI ,  US.
IMCO, INC.
MOORESTOWN,  NJ,  US.
Contract Manufacturer;  
IMCO, INC.
MOORESTOWN,  NJ ,  US.
IMCO, INC.
NORTH RIVERSIDE,  IL,  US.
Initial Importer;  
IMCO, INC.
NORTH RIVERSIDE,  IL ,  US.
IMDS, INC.
CLEARWATER,  FL,  US.
Initial Importer;  
IMDS, INC.
CLEARWATER,  FL ,  US.
IMDSOFT
TEL-AVIV,  IS.
Manufacturer;  
IMDSOFT
TEL-AVIV,  IS.
IME HEALTH SUPPLIES, INC.
IRVING,  TX,  US.
Initial Importer;  
IME HEALTH SUPPLIES, INC.
IRVING,  TX ,  US.
IMEB, INC.
SAN MARCOS,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IMEB, INC.
SAN MARCOS,  CA ,  US.
IMEC
CHICO,  CA,  US.
Initial Importer;  
IMEC ENT.
CHICO,  CA ,  US.
IMED TECHNOLOGY, INC.
DALLAS,  TX,  US.
Contract Manufacturer;  
IMED TECHNOLOGY, INC.
DALLAS,  TX ,  US.
IMED, LTD.
BUDAPEST,  HU.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
IMED, LTD.
BUDAPEST,  HU.
IMEDGE, LLC.
EXCELSIOR,  MN,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
IMEDGE, LLC.
EXCELSIOR,  MN ,  US.
IMEQUIPOS IMETAN S.A.
BOGOTA, CUNDINAMARCA,  CO.
Manufacturer;  
IMEQUIPOS IMETAN S.A.
BOGOTA, CUNDINAMARCA,  CO.
IMEQUIPOS IMETAN S.A.
CUCUTA, NORTE DE SANTANDER,  CO.
Manufacturer;  
IMEQUIPOS IMETAN S.A.
BOGOTA, CUNDINAMARCA,  CO.
IMETRIKUS, INC.
CARLSBAD,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
IMETRIKUS, INC.
CARLSBAD,  CA ,  US.
IMEX
SCOTTS VALLEY,  CA,  US.
Initial Importer;  
IMEX
SCOTTS VALLEY,  CA ,  US.
IMEXCO GENERAL LTD.
HERTZLIA, PITUAH,  IS.
Manufacturer;   Specification Developer;  
ISRAEL AIRCRAFT INDUSTRIES LTD.
YAHUD,  IS.
I-MING SANITARY MATERIALS CO., LTD.
HSIHU, CHANG HUA,  TW.
Manufacturer;  
I-MING SANITARY MATERIALS CO., LTD.
HSIHU, CHANG HUA,  TW.
IMIX ADR FINLAND OY
TAMPERE,  FI.
Manufacturer;  
IMIX ADR FINLAND OY
TAMPERE,  FI.
IMK DISTRIBUTOR, INC.
NEW YORK,  NY,  US.
Initial Importer;  
IMK DISTRIBUTOR, INC.
NEW YORK,  NY ,  US.
IMM GROUP, INC.
MINNEAPOLIS,  MN,  US.
Initial Importer;  
IMM GROUP, INC.
MINNEAPOLIS,  MN ,  US.
IMMAGINE EYEWEAR SRL
TAI DI PIEVE DI CADORE (BL),  IT.
Manufacturer;  
IMMAGINE EYEWEAR SRL
TAI DI PIEVE DI CADORE (BL),  IT.
IMMALA, LLC
BAYONNE,  NJ,  US.
Initial Importer;  
IMMALA, LLC
BAYONNE,  NJ ,  US.
IMMCO DIAGNOSTICS, INC.
BUFFALO,  NY,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
IMMCO DIAGNOSTICS, INC.
BUFFALO,  NY ,  US.

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Last Modified: 29 April 2006
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