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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
DIANA DOLLS FASHIONS, INC.
STONEY CREEK, ONTARIO,  CA.
Unregistered Foreign Lister;  
DIANA DOLLS FASHIONS, INC.
STONEY CREEK, ONTARIO,  CA.
DIAPEDIA, LLC
STATE COLLEGE,  PA,  US.
Manufacturer;  
DIAPEDIA, LLC
STATE COLLEGE,  PA ,  US.
DIAPHARMA GROUP, INC.
WEST CHESTER,  OH,  US.
Initial Importer;   Specification Developer;  
DIAPHARMA GROUP, INC.
WEST CHESTER,  OH ,  US.
DIAPULSE CORP. OF AMERICA
GREAT NECK,  NY,  US.
Manufacturer;  
DIAPULSE CORP. OF AMERICA
GREAT NECK,  NY ,  US.
DIARECT AG
FREIBURG,  GM.
Manufacturer;  
DIARECT AG
FREIBURG,  GM.
DIASOL, INC.
NORTH HOLLYWOOD,  CA,  US.
Manufacturer;  
DIASOL, INC.
NORTH HOLLYWOOD,  CA ,  US.
DIASORIN AB
SUNDBYBERG,  SW.
Contract Manufacturer;   Manufacturer;  
DIASORIN S.P.A.
SALUGGIA (VC),  IT.
DIASORIN S.P.A.
SALUGGIA (VC),  IT.
Manufacturer;   Specification Developer;  
DIASORIN S.P.A.
SALUGGIA (VC),  IT.
DIASORIN, INC.
STILLWATER,  MN,  US.
Manufacturer;   Specification Developer;  
DIASORIN S.P.A.
SALUGGIA (VC),  IT.
DIASUD SARL
TEMARA,  MO.
Manufacturer;  
VARENKOR SA
DELEMONT,  SZ.
DIASWISS S.A.
NYON,  SZ.
Manufacturer;  
RENE F. ZUBER
MONTANA,  SZ.
DIASYS CORP.
WATERBURY,  CT,  US.
Manufacturer;   Specification Developer;  
DIASYS CORP.
WATERBURY,  CT ,  US.
DIASYS EUROPE, LTD.
WOKINGHAM, BERKSHIRE,  UK.
Manufacturer;  
DIASYS CORP.
WATERBURY,  CT ,  US.
DIASYS EUROPE, LTD.
WOKINGHAM, BORKS,  UK.
Manufacturer;  
DIASYS EUROPE, LTD.
WOKINGHAM, BERKS,  UK.
DIATECH DIAMOND USA, INC.
CHARLESTON,  SC,  US.
Initial Importer;  
DIATECH DIAMOND USA, INC.
CHARLESTON,  SC ,  US.
DIATOME U.S.
HATFIELD,  PA,  US.
Initial Importer;  
DIATOME U.S.
HATFIELD,  PA ,  US.
DIATRON, INC.
JUPITER,  FL,  US.

DIATRON, INC.
JUPITER,  FL ,  US.
DIAZYME LABORATORIES
SAN DIEGO,  CA,  US.
Manufacturer;  
GENERAL ATOMICS
SAN DIEGO,  CA ,  US.
DIBERLENTES, INC.
MIAMI,  FL,  US.
Initial Importer;  
DIBERLENTES, INC.
MIAMI,  FL ,  US.
DI-CHEM CONCENTRATE, INC.
LEWISBERRY,  PA,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
DI-CHEM, INC.
CHAMPLIN,  MN ,  US.
DI-CHEM, INC.
CHAMPLIN,  MN,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DI-CHEM, INC.
CHAMPLIN,  MN ,  US.
DIDAGE SALES CO, INC.
WARSAW,  IN,  US.
Initial Importer;  
DIDAGE SALES CO, INC.
WARSAW,  IN ,  US.
DIDRICK MEDICAL INC.
NAPLES,  FL,  US.
Specification Developer;  
DIDRICK MEDICAL INC.
NAPLES,  FL ,  US.
DIEDENHOFEN HEALTH CARE
ST. AUGUSTIN 3/BONN,  GM.
Manufacturer;  
DIEDENHOFEN HEALTH CARE
ST. AUGUSTIN 3/BONN,  GM.
DIEHM IWA HANDELSGESELLSCHAFT & CO. OHG
ROSSDORF,  GM.
Foreign Exporter;   Repackager/Relabeller;  
DIEHM IWA HANDELSGESELLSCHAFT & CO. OHG
ROSSDORF,  GM.
DIELECTRICS INDUSTRIES, INC.
CHICOPEE,  MA,  US.
Contract Manufacturer;  
DIELECTRICS INDUSTRIES, INC.
CHICOPEE,  MA ,  US.
DIESSE DIAGNOSTICA SENESE S.P.A
MONTERIGGIONI, SI,  IT.
Manufacturer;  
DIESSE DIAGNOSTICA SENESE S.P.A
MILANO,  IT.
DIESSE INC.
HIALEAH,  FL,  US.
Initial Importer;  
DIESSE INC.
HIALEAH,  FL ,  US.
DIETER STEINHILBER
OFTERDINGEN,  GM.
Manufacturer;  
DIETER STEINHILBER
OFTERDINGEN,  GM.
DIETERLE BMBH
WINDSBACH,  GM.
Unregistered Foreign Lister;  
DIETERLE BMBH
WINDSBACH,  GM.
DIFFRACTIVE OPTICS, LTD.
SHATIN, N.T. HONG KONG,  CH.
Manufacturer;  
DIFFRACTIVE OPTICS, LTD.
SHATIN, N.T. HONG KONG,  CH.
DIFFUPLAST SRL
OLGIATE OLONA,  IT.
Manufacturer;  
GIULIO VIGNATI, TECHNICAL DIRECTOR
OLGIATE OLONA,  IT.
DIFFUSAN SALES, INC.
VALLEY STREAM,  NY,  US.
Initial Importer;  
DOTT. ALDO AUGUSTO BONAPACE
MILANO,  IT.
DIGENE CORP.
GAITHERSBURG,  MD,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
DIGENE CORP.
GAITHERSBURG,  MD ,  US.
DIGIBIO TECHNOLOGY CORP.
TAIPEI HSIEN,  TW.
Manufacturer;  
DIGIBIO TECHNOLOGY CORP.
TAIPEI HSIEN,  TW.
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
BOYNTON BEACH,  FL,  US.
Manufacturer;  
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
BOYNTON BEACH,  FL ,  US.
DIGICO ELECTRONIC MANUFACTURING, INC.
LAVAL, QUEBEC,  CA.
Contract Manufacturer;  
DIGICO ELECTRONIC MANUFACTURING, INC.
LAVAL, QUEBEC,  CA.
DIGIDENT LTD.
NESHER,,  IS.
Manufacturer;  
DIGIDENT LTD.
NESHER,,  IS.
DIGIFLEX INDIA LTD.
NEW DELHI,  IN.
Unregistered Foreign Lister;  
DIGIFLEX INDIA LTD.
NEW DELHI,  IN.
DIGIMAX INNOVATIVE PRODUCTS LTD
HSIN TIEN CITY,  TW.
Manufacturer;  
DIGIMAX INNOVATIVE PRODUCTS LTD
HSIN TIEN CITY,  TW.

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Last Modified: 29 April 2006
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