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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
DESK 21 CO., LTD.
KOFU-SHI, YAMANASHI PREFECTURE,  JA.
Manufacturer;  
DESK 21 CO., LTD.
KOFU-SHI, YAMANASHI PREFECTURE,  JA.
DESTAL INDUSTRIES, INC.
COLUMBUS,  IN,  US.
Manufacturer;  
DESTAL INDUSTRIES, INC.
COLUMBUS,  IN ,  US.
DETAX GMBH & CO. KG
ETTLINGEN,  GM.
Manufacturer;  
DETAX GMBH & CO. KG
ETTLINGEN,  GM.
DETERMINED PRODUCTIONS, INC.
LARKSPUR,  CA,  US.
Initial Importer;  
DETERMINED PRODUCTIONS, INC.
LARKSPUR,  CA ,  US.
DETROIT OXYGEN & MEDICAL EQUIPMENT CO.
WARREN,  MI,  US.

DETROIT OXYGEN & MEDICAL EQUIPMENT CO.
WARREN,  MI ,  US.
DEUTERONOMY MANAGEMENT SERVICES,INC.
NICEVILLE,  FL,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
DEUTERONOMY MANAGEMENT SERVICES,INC.
NICEVILLE,  FL ,  US.
DEUTSCHE NEMECTRON GMBH
KARLSRUHE,  GM.
Manufacturer;   Specification Developer;  
DEUTSCHE NEMECTRON GMBH
KARLSRUHE,  GM.
DEVAX, INC.
IRVINE,  CA,  US.
Manufacturer;  
DEVAX, INC.
IRVINE,  CA ,  US.
DEVELOP, MANUFACTURE & TEST
GERMANTOWN,  MD,  US.
Contract Manufacturer;  
DEVELOP, MANUFACTURE & TEST
GERMANTOWN,  MD ,  US.
DEVELOPMENTAL ENT. CORP.
NORRISTOWN,  PA,  US.
Repackager/Relabeller;  
DEVELOPMENTAL ENT. CORP.
NORRISTOWN,  PA ,  US.
DEVELOPMENTAL PATHWAY DBA PATHWAYS HOME CARE CENTE
AURORA,  CO,  US.
Initial Importer;  
DEVELOPMENTAL PATHWAY DBA PATHWAYS HOME CARE CENTE
AURORA,  CO ,  US.
DEVEMED GMBH
NEUHAUSEN OB ECK,  GM.
Repackager/Relabeller;  
DEVEMED GMBH
NEUHAUSEN OB ECK,  GM.
DEVICES & SERVICES CO.
DALLAS,  TX,  US.
Manufacturer;  
DEVICES & SERVICES CO.
DALLAS,  TX ,  US.
DEVIN SURGICAL SUCTION SYSTEM
LILBURN,  GA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
DEVIN SURGICAL SUCTION SYSTEM
LILBURN,  GA ,  US.
DEVINE MEDICAL PRODUCTS
MARYSVILLE,  CA,  US.
Manufacturer;  
DEVINE MEDICAL PRODUCTS
MARYSVILLE,  CA ,  US.
DEVISHRI INC.
FAIRFIELD,  NJ,  US.
Initial Importer;  
DEVISHRI INC.
FAIRFIELD,  NJ ,  US.
DEVON INTERNATIONAL TRADING
KING OF PRUSSIA,  PA,  US.
Initial Importer;  
DEVON INTERNATIONAL TRADING
KING OF PRUSSIA,  PA ,  US.
DEVON SAFETY PRODUCTS, INC.
SHANTOU,  CH.
Manufacturer;  
DEVON SAFETY PRODUCTS, INC.
KING OF PRUSSIA,  PA ,  US.
DE'VONS OPTICS, INC.
RANCHO CUCAMONGA,  CA,  US.
Initial Importer;  
DE'VONS OPTICS, INC.
RANCHO CUCAMONGA,  CA ,  US.
DEW TECHNOLOGIES, INC
FAIRBORN,  OH,  US.
Contract Manufacturer;  
DEW TECHNOLOGIES, INC
FAIRBORN,  OH ,  US.
DEWAL SURGICAL CO.
SIALKOT,  PK.
Manufacturer;  
DEWAL SURGICAL CO.
SIALKOT,  PK.
DEWALL ENT., INC.
OMAHA,  NE,  US.
Specification Developer;  
DEWALL ENT., INC.
OMAHA,  NE ,  US.
DEWIMED MEDIZININTECHNIK GMBH
TUTTLINGEN,  GM.
Manufacturer;  
DEWIMED MEDIZININTECHNIK GMBH
TUTTLINGEN,  GM.
DEXALL BIOMEDICAL LABS, INC.
GAITHERSBURG,  MD,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
DEXALL BIOMEDICAL LABS, INC.
GAITHERSBURG,  MD ,  US.
DEXCOM, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
DEXCOM, INC.
SAN DIEGO,  CA ,  US.
DEXIS LLC
DES PLAINES,  IL,  US.
Manufacturer;   Specification Developer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
DEXTA CORP.
NAPA,  CA,  US.
Manufacturer;  
DEXTA CORP.
NAPA,  CA ,  US.
DEXTERITY SURGICAL, INC.
HOUSTON,  TX,  US.
Specification Developer;  
DEXTERITY SURGICAL, INC.
HOUSTON,  TX ,  US.
DEXTEUS, INC.
LAKE FOREST,  CA,  US.
Specification Developer;  
DEXTEUS, INC.
LAKE FOREST,  CA ,  US.
DEY, L.P.
ALLEN,  TX,  US.
Initial Importer;  
DEY, L.P.
NAPA,  CA ,  US.
DEY, L.P.
NAPA,  CA,  US.
Specification Developer;  
DEY, L.P.
NAPA,  CA ,  US.
DFL-INDUSTRIA E COMERCIO LTDA
RIO DE JANEIRO -RJ,  BR.
Manufacturer;  
DFL-INDUSTRIA E COMERCIO LTDA
RIO DE JANEIRO -RJ,  BR.
DFM OPTICAS INTERNATIONAL SELECTA
COLUMBIA,  CO.
Manufacturer;  
DFM OPTICAS INTERNATIONAL SELECTA
COLOMBIA,  CO.
DFS HAWAII, A DIVISION OF DFS GROUP L.P.
HONOLULU,  HI,  US.
Initial Importer;  
DFS HAWAII, A DIVISION OF DFS GROUP L.P.
HONOLULU,  HI ,  US.
DFS NORTH AMERICA
TORRANCE,  CA,  US.
Initial Importer;  
DFS NORTH AMERICA
TORRANCE,  CA ,  US.
DGH TECHNOLOGY, INC.
EXTON,  PA,  US.
Initial Importer;   Manufacturer;  
DGH TECHNOLOGY, INC.
EXTON,  PA ,  US.
DHARMA MEDIPRO, PT
SERANG - BANTEN,  ID.
Manufacturer;  
DHARMA MEDIPRO, PT
SERANG - BANTEN,  ID.
DHARMA POLIMETAL, PT
TANGERANG, JAWA BARAT,  ID.
Manufacturer;  
DHARMA POLIMETAL, PT
TANGERANG, JAWA BARAT,  ID.
DHEF, INC.
TAIPEI,  TW.
Manufacturer;  
DHEF, INC.
TAIPEI,  TW.
DI ESSE S.R.L. DI R.A. DE SILVERESTRO E C.
DOMEGGE DI CADORE,  IT.
Manufacturer;  
DI ESSE S.R.L. DI R.A. DE SILVERESTRO E C.
DOMEGGE DI CADORE,  IT.

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Last Modified: 29 April 2006
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