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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
DI SANTO TECHNOLOGY, INC.
STAMFORD,  CT,  US.
Contract Manufacturer;  
DI SANTO TECHNOLOGY, INC.
STAMFORD,  CT ,  US.
DIA ENTERPRISE LTD.
OSAKA,  JA.
Repackager/Relabeller;  
DIA ENTERPRISE LTD.
OSAKA,  JA.
DIABETES SENTRY PRODUCTS
BELLINGHAM,  WA,  US.
Specification Developer;  
DIABETES SENTRY PRODUCTS
BELLINGHAM,  WA ,  US.
DIABETES TECHNOLOGIES, INC.
THOMASVILLE,  GA,  US.
Manufacturer;   Repackager/Relabeller;  
DIABETES TECHNOLOGIES, INC.
THOMASVILLE,  GA ,  US.
DIACARE CORP.
ANAHEIM,  CA,  US.
Initial Importer;  
DIACARE CORP.
ANAHEIM,  CA ,  US.
DIACK
BEULAH,  MI,  US.
Manufacturer;  
AURIC ENT., INC.
BEULAH,  MI ,  US.
DIACOR, INC.
SALT LAKE CITY,  UT,  US.
Manufacturer;   Specification Developer;  
DIACOR, INC.
SALT LAKE CITY,  UT ,  US.
DIADEM CORP.
IBARAGI,  JA.
Manufacturer;  
DIADEM CORP.
IBARAGI,  JA.
DIADENT GROUP INTERNATIONAL
CHONGJU CITY,,  KS.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DIADENT GROUP INTL., INC.
CHONGJU CITY,  KS.
DIADENT GROUP INTL., INC.
BURNABY, B.C.,  CA.
Foreign Exporter;   Repackager/Relabeller;  
DIADENT GROUP INTL., INC.
BURNABY, B.C.,  CA.
DIADEXUS, INC.
SOUTH SAN FRANCISCO,  CA,  US.
Manufacturer;  
DIADEXUS, INC.
SOUTH SAN FRANCISCO,  CA ,  US.
DIAGEN CORP.
BRACKENRIDGE,  PA,  US.
Manufacturer;  
DIAGEN CORP.
BRACKENRIDGE,  PA ,  US.
DIAGNOCURE, INC.
QUEBEC,  CA.
Manufacturer;  
DIAGNOCURE, INC.
QUEBEC,  CA.
DIAGNOSTIC ACCESS LLC
BOONTON TWP,  NJ,  US.
Initial Importer;  
DIAGNOSTIC ACCESS LLC
BOONTON TWP,  NJ ,  US.
DIAGNOSTIC AUTOMATION, INC.
CALABASAS,  CA,  US.
Initial Importer;   Manufacturer;  
DIAGNOSTIC AUTOMATION
CALABASAS,  CA ,  US.
DIAGNOSTIC CHEMICALS LTD.
CHARLOTTETOWN, P.E.I.,  CA.
Manufacturer;  
DIAGNOSTIC CHEMICALS LTD.
CHARLOTTETOWN, P.E.I.,  CA.
DIAGNOSTIC CHEMICALS, LTD. (USA)
OXFORD,  CT,  US.
Initial Importer;  
DIAGNOSTIC CHEMICALS, LTD. (USA)
OXFORD,  CT ,  US.
DIAGNOSTIC DEVICES INC.
MIAMI,  FL,  US.
Initial Importer;  
DIAGNOSTIC DEVICES INC.
MIAMI,  FL ,  US.
DIAGNOSTIC GRIFOLS, S.A.
BARCELONA,  SP.
Manufacturer;  
DIAGNOSTIC GRIFOLS, S.A.
BARCELONA,  SP.
DIAGNOSTIC GROUP LLC
EDEN PRAIRIE,  MN,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
WILLIAM DEMANT HOLDINGS, A/S
SMORUM,  DA.
DIAGNOSTIC HYBRIDS, INC.
ATHENS,  OH,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DIAGNOSTIC HYBRIDS, INC.
ATHENS,  OH ,  US.
DIAGNOSTIC IMAGING
DELRAN,  NJ,  US.
Initial Importer;  
DIAGNOSTIC IMAGING
DELRAN,  NJ ,  US.
DIAGNOSTIC IMAGING SPECIALISTS CORP.
ST. MALO, MANITOBA,  CA.
Manufacturer;  
DIAGNOSTIC IMAGING SPECIALISTS CORP.
WINNIPEG, MANITOBA,  CA.
DIAGNOSTIC IMAGING, INC.
EVERETT,  WA,  US.
Initial Importer;  
DIAGNOSTIC IMAGING, INC.
EVERETT,  WA ,  US.
DIAGNOSTIC INSTRUMENT GROUP
TAMPA,  FL,  US.
Initial Importer;  
DIAGNOSTIC INSTRUMENT GROUP
TAMPA,  FL ,  US.
DIAGNOSTIC INSTRUMENTS, INC.
LORAIN,  OH,  US.
Manufacturer;  
DIAGNOSTIC INSTRUMENTS, INC.
LORAIN,  OH ,  US.
DIAGNOSTIC MEDICAL EQUIPMENT, INC.
MOORE,  OK,  US.
Initial Importer;  
DIAGNOSTIC MEDICAL EQUIPMENT, INC.
MOORE,  OK ,  US.
DIAGNOSTIC MEDICAL SYSTEMS
MONTPELLIER, HERAULT,  FR.
Manufacturer;  
DIAGNOSTIC MEDICAL SYSTEMS
MONTPELLIER, HERAULT,  FR.
DIAGNOSTIC MONITORING SOFTWARE
STATELINE,  NV,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
DIAGNOSTIC MONITORING SOFTWARE
STATELINE,  NV ,  US.
DIAGNOSTIC PRODS. FOR IMAGING, INC.
RIO PIEDRAS,  PR,  US.
Initial Importer;  
DIAGNOSTIC PRODS. FOR IMAGING, INC.
RIO PIEDRAS,  PR ,  US.
DIAGNOSTIC PRODUCTS CORP.
LOS ANGELES,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
DIAGNOSTIC PRODUCTS CORP.
LOS ANGELES,  CA ,  US.
DIAGNOSTIC PRODUCTS CORPORATION
LOS ANGELES,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
DIAGNOSTIC PRODUCTS CORP.
LOS ANGELES,  CA ,  US.
DIAGNOSTIC SOLUTIONS, INC.
IRVINE,  CA,  US.
Specification Developer;  
DIAGNOSTIC SOLUTIONS, INC.
IRVINE,  CA ,  US.
DIAGNOSTIC SONAR LTD.
LIVINGSTON,  UK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DIAGNOSTIC SONAR LTD.
LIVINGSTON,  UK.
DIAGNOSTIC SPECIALTIES
METUCHEN,  NJ,  US.
Manufacturer;  
DIAGNOSTIC SPECIALTIES
METUCHEN,  NJ ,  US.
DIAGNOSTIC SUPPORT USA INC.
MIAMI BEACH,  FL,  US.
Initial Importer;   Manufacturer;  
DIAGNOSTIC SUPPORT USA INC.
MIAMI BEACH,  FL ,  US.
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
WEBSTER,  TX,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
WEBSTER,  TX ,  US.
DIAGNOSTIC TECHNOLOGY SYSTEMS, INC.
MIAMI LAKES,  FL,  US.
Initial Importer;  
DIAGNOSTIC TECHNOLOGY SYSTEMS, INC.
MIAMI LAKES,  FL ,  US.
DIAGNOSTIC TECHNOLOGY, INC.
HAUPPAUGE,  NY,  US.
Manufacturer;  
DIAGNOSTIC TECHNOLOGY, INC.
HAUPPAUGE,  NY ,  US.
DIAGNOSTIC TEST GROUP, LLC
BOCA RATON,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
DIAGNOSTIC TEST GROUP, LLC
BOCA RATON,  FL ,  US.

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Last Modified: 29 April 2006
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