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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
DEMMER CORP.
LANSING,  MI,  US.
Contract Manufacturer;  
DEMMER CORP.
LANSING,  MI ,  US.
DEN CHANG HARDWARE INDUSTRY CO.,LTD.
TAIPEI,  TW.
Repackager/Relabeller;  
DEN CHANG HARDWARE INDUSTRY CO.,LTD.
TAIPEI,  TW.
DEN HELDER LOGISTICS INC.
BAYONNE,  NJ,  US.
Initial Importer;  
DEN HELDER LOGISTICS INC.
BAYONNE,  NJ ,  US.
DEN TAG S.R.L.
MANIAGO, PN.,  IT.
Manufacturer;  
DEN TAG S.R.L.
MANIAGO, PN.,  IT.
DENART AESTHETIC DESIGN, S.F.
SAN FRANCISCO,  CA,  US.
Initial Importer;   Reprocessor of single-use devices;   Manufacturer;  
DENART AESTHETIC DESIGN, S.F.
SAN FRANCISCO,  CA ,  US.
DENART YUUGENKAISHA
NISHI-KU, OSAKA,  JA.
Contract Manufacturer;  
DENART YUUGENKAISHA
NISHI-KU, OSAKA,  JA.
DENBUR, INC.
HINSDALE,  IL,  US.
Initial Importer;  
DENBUR, INC.
HINSDALE,  IL ,  US.
DENDREON CORP.
SEATTLE,  WA,  US.
Manufacturer;   Specification Developer;  
DENDREON CORP.
SEATTLE,  WA ,  US.
DENDRITE INTERACTIVE MARKETING LLC
TOTOWA,  NJ,  US.
Initial Importer;  
DENDRITE INTERACTIVE MARKETING LLC
TOTOWA,  NJ ,  US.
DENIMED ELECTRONICA S.H.
CORDOBA,  AR.
Manufacturer;  
DENIMED ELECTRONICA S.H.
CORDOBA,  AR.
DENISE INDUSTRIES LTD.
MIGDAL HAEMEK,  IS.
Unregistered Foreign Lister;  
DENISE INDUSTRIES LTD.
MIGDAL HAEMEK,  IS.
DENISON PHARMACEUTICALS, INC.
PAWTUCKET,  RI,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DENISON PHARMACEUTICALS, INC.
PAWTUCKET,  RI ,  US.
DENKA SEIKEN CO., LTD.
GOSEN-SHI, NIIGATA,  JA.
Manufacturer;  
DENKA SEIKEN CO., LTD.
CHUO-KU, TOKYO,  JA.
DENKA SEIKEN CO., LTD. KAGAMIDA FACTORY
GOSEN-SHI, NIIGATA,  JA.
Manufacturer;  
DENKA SEIKEN CO., LTD.
CHUO-KU, TOKYO,  JA.
DENKI KAGAKU KOGYO KABUSHIKI KAISHA
TOKYO,  JA.
Manufacturer;  
DENKI KAGAKU KOGYO KABUSHIKI KAISHA
TOKYO,  JA.
DEN-MAT CORP.
SANTA MARIA,  CA,  US.
Initial Importer;   Manufacturer;  
DEN-MAT CORP.
SANTA MARIA,  CA ,  US.
DENMED DIRECT SERVICES LIMITED
CANTERBURY, KENT,  UK.
Repackager/Relabeller;  
DENMED DIRECT SERVICES LIMITED
CANTERBURY, KENT,  UK.
DENMED TECHNOLOGIES, INC.
ORANGE,  CA,  US.
Manufacturer;   Remanufacturer;  
DENMED TECHNOLOGIES, INC.
ORANGE,  CA ,  US.
DENNIS FOLAND, INC.
ONTARIO,  CA,  US.
Initial Importer;  
DENNIS FOLAND, INC.
ONTARIO,  CA ,  US.
DENNIS R DOS SANTOS
SAO PAULO,  BR.
Contract Manufacturer;  
DENNIS R DOS SANTOS
SAO PAULO,  BR.
DENOVO
BALDWIN PARK,  CA,  US.
Initial Importer;   Manufacturer;  
DENTAL PHONES SALES, INC.
BALDWIN PARK,  CA ,  US.
DENPLUS, INC.
LONGUEUIL, QUEBEC,  CA.
Foreign Exporter;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DENPLUS, INC.
LONGUEUIL, QUEBEC,  CA.
DENT CORP. RESEARCH & DEVELOPMENT
WHITE PLAINS,  NY,  US.
Initial Importer;   Specification Developer;  
DENT CORP. RESEARCH & DEVELOPMENT
WHITE PLAINS,  NY ,  US.
DENT EXPORT
NEW CITY,  NY,  US.
Initial Importer;  
DENT EXPORT
NEW CITY,  NY ,  US.
DENT FRESH USA, INC.
AVENTURA,  FL,  US.
Initial Importer;   Specification Developer;  
DENT FRESH USA, INC.
AVENTURA,  FL ,  US.
DENT ZAR, INC.
LOS ANGELES,  CA,  US.
Manufacturer;   Repackager/Relabeller;  
DENT ZAR, INC.
LOS ANGELES,  CA ,  US.
DENTAC AB
NYNASHAMN,  SW.
Manufacturer;  
DENTAC AB
FALSTERBO,  SW.
DENTACO A.S.
BERGEN,  NO.
Manufacturer;  
DENTACO A.S.
BERGEN,  NO.
DENTACO GMBH
BAD HOMBURG,  GM.
Manufacturer;  
DENTACO GMBH
BAD HOMBURG,  GM.
DENTAFIX UK LTD.
CAMBERLEY SURREY,  UK.
Manufacturer;  
DENTAFIX LTD.
CAMBERLEY SURREY,  UK.
DENT-AIDS
NEW DELHI,  IN.
Contract Manufacturer;   Manufacturer;  
DENT-AIDS
NEW DELHI,  IN.
DENTAK
PARIS,  FR.
Manufacturer;  
DENTAK
PARIS,  FR.
DENTAL AKTIESELSKABET AF 1934
RODOVRE,  DA.
Manufacturer;  
DENTAL AKTIESELSKABET AF 1934
RODOVRE,  DA.
DENTAL ALTERNATIVE DEALERS, LTD.
SINKING SPRING,  PA,  US.
Initial Importer;  
DENTAL ALTERNATIVE DEALERS, LTD.
SINKING SPRING,  PA ,  US.
DENTAL ANCHOR SYSTEMS, INC.
ROCKAWAY,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
DENTAL ANCHOR SYSTEMS, INC.
ROCKAWAY,  NJ ,  US.
DENTAL APPLIANCE INNOVATORS, INC.
ERIE,  PA,  US.
Specification Developer;  
DENTAL APPLIANCE INNOVATORS, INC.
ERIE,  PA ,  US.
DENTAL ARTE, INC.
POWAY,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
DENTAL ARTE, INC.
POWAY,  CA ,  US.
DENTAL ARTS CERAMICS
METRO MANILA,  RP.
Manufacturer;  
DENTAL ARTS CERAMICS
METRO MANILA,  RP.
DENTAL ARTS LABORATORIES, INC.
AURORA,  IL,  US.
Initial Importer;  
DENTAL ARTS LABORATORIES, INC.
PEORIA,  IL ,  US.
DENTAL ARTS LABORATORIES, INC.
PEORIA,  IL,  US.
Initial Importer;  
DENTAL ARTS LABORATORIES, INC.
PEORIA,  IL ,  US.

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Last Modified: 29 April 2006
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