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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
TERUMO MEDICAL CORP.
ELKTON,  MD,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;   U.S. Manufacturer of Export Only Devices;
TERUMO MEDICAL CORP.
SOMERSET,  NJ ,  US.
TERUMO MEDICAL CORP.
MEMPHIS,  TN,  US.
Initial Importer;  
TERUMO MEDICAL CORP.
SOMERSET,  NJ ,  US.
TERUMO MEDICAL CORP.
PHOENIX,  AZ,  US.
Initial Importer;  
TERUMO MEDICAL CORP.
SOMERSET,  NJ ,  US.
TERUMO MEDICAL PRODUCTS HANGZHOU CO., LTD.
HANGZHOU,  CH.
Manufacturer;  
TERUMO CORP.
SHIBUYA-KU, TOKYO,  JA.
TESCO ASSOCIATES, INC.
TYNGSBOROUGH,  MA,  US.
Contract Manufacturer;  
TESCO ASSOCIATES, INC.
TYNGSBOROUGH,  MA ,  US.
TESSERA INC.
SEATTLE,  WA,  US.
Specification Developer;  
TESSERA INC.
SEATTLE,  WA ,  US.
TESSITURA TEXSIVA SNC
POZZUOLO DEL FRIULI (UD),  IT.
Unregistered Foreign Lister;  
TESSITURA TEXSIVA SNC
POZZUOLO DEL FRIULI (UD),  IT.
TESSY PLASTICS CORP.
ELBRIDGE,  NY,  US.
Contract Manufacturer;  
TESSY PLASTICS CORP.
ELBRIDGE,  NY ,  US.
TEST MEDICAL SYMPTOMS @ HOME, INC.
MARIA STEIN,  OH,  US.
Initial Importer;  
TEST MEDICAL SYMPTOMS @ HOME, INC.
MARIA STEIN,  OH ,  US.
TEST RITE INTL. CO., LTD.
TAIPEI, TAIWAN R.O.C.,  TW.
Unregistered Foreign Lister;  
TEST RITE INTL. CO., LTD.
TAIPEI, TAIWAN R.O.C.,  TW.
TESTPRINT, INC.
CHERRY HILL,  NJ,  US.
Initial Importer;  
TESTPRINT, INC.
CHERRY HILL,  NJ ,  US.
TETON MACHINE COMPANY, INC.
PAYETTE,  ID,  US.
Contract Manufacturer;  
TETON MACHINE COMPANY, INC.
PAYETTE,  ID ,  US.
TETRA MEDICAL SUPPLY CORP.
NILES,  IL,  US.
Repackager/Relabeller;  
TETRA MEDICAL SUPPLY CORP.
NILES,  IL ,  US.
TETRACORE, INC
ROCKVILLE,  MD,  US.
Manufacturer;  
TETRACORE, INC
ROCKVILLE,  MD ,  US.
TETRAD CORPORATION
ENGLEWOOD,  CO,  US.
Manufacturer;  
W. L. GORE & ASSOCIATES, INC.
NEWARK,  DE ,  US.
TETROX MFG. CO.
DETROIT,  MI,  US.
Manufacturer;  
TETROX CORP.
DETROIT,  MI ,  US.
TEVA NEUROSCIENCE, INC.
SELLERSVILLE,  PA,  US.
Initial Importer;  
TEVA PHARMACEUTICAL INDUSTRIES, LTD.
PETAH-TIQVA,  IS.
TEVA PHARMACEUTICAL INDUSTRIES, LTD.
PETAH TIKVA,  IS.
Manufacturer;  
TEVA GROUP
HACKENSACK,  NJ ,  US.
TEXAS ASO CORP.
EL PASO,  TX,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ASO CORP.
SARASOTA,  FL ,  US.
TEXAS BIOGENE, INC.
RICHARDSON,  TX,  US.
Specification Developer;  
TEXAS BIOGENE, INC.
RICHARDSON,  TX ,  US.
TEXAS D.M.E., INC.
CLEBURNE,  TX,  US.
Initial Importer;  
TEXAS D.M.E., INC.
CLEBURNE,  TX ,  US.
TEXAS ELECTROLYSIS SUPPLY
HOUSTON,  TX,  US.
Initial Importer;  
TEXAS ELECTROLYSIS SUPPLY
HOUSTON,  TX ,  US.
TEXAS IMMUNOLOGY, INC.
TYLER,  TX,  US.
Specification Developer;  
TEXAS IMMUNOLOGY, INC.
TYLER,  TX ,  US.
TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY
REFUGIO,  TX,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY
REFUGIO,  TX ,  US.
TEXAS MEDICAL INDUSTRIES, INC.
ROYSE CITY,  TX,  US.
Manufacturer;  
TEXAS MEDICAL INDUSTRIES, INC.
ROYSE CITY,  TX ,  US.
TEXAS ORTHOPAEDIC PRODUCTS & SERVICES, L.L.C.
ROCKWALL,  TX,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
TEXAS ORTHOPAEDIC PRODUCTS & SERVICES, L.L.C.
ROCKWALL,  TX ,  US.
TEX-CARE MEDICAL
BURLINGTON,  NC,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
FLYNT AMTEX, INC.
BURLINGTON,  NC ,  US.
TEXCEL, LLC
EAST LONGMEADOW,  MA,  US.
Contract Manufacturer;  
TEXCEL, LLC
EAST LONGMEADOW,  MA ,  US.
TEXIN CO.
MONGKOK, KOWLOON,  HK.
Unregistered Foreign Lister;  
TEXIN CO.
MONGKOK, KOWLOON,  HK.
TEXLA INDUSTRIES SDN. BHD.
KEPONG, KUALA LUMPUR,  MY.
Manufacturer;  
TEXLA INDUSTRIES SDN. BHD.
KEPONG, KUALA LUMPUR,  MY.
TEXLINEN (PVT.) LTD.
BIYAGAMA,  CE.
Unregistered Foreign Lister;  
TEXLINEN (PVT.) LTD.
BIYAGAMA,  CE.
TEXMED, INC.
WESTON,  FL,  US.
Initial Importer;  
TEXMED, INC.
WESTON,  FL ,  US.
TEXPIA, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
TEXPIA, INC.
LOS ANGELES,  CA ,  US.
TEXPON LTDA.
BOGOTA,  CO.
Manufacturer;  
TEXPON LTDA.
BOGOTA,  CO.
TEXSTAR TECHNOLOGY INC.
LUBBOCK,  TX,  US.
Manufacturer;  
TEXSTAR TECHNOLOGY INC.
LUBBOCK,  TX ,  US.
TEXSTRIP MANUFACTURING SDN. BHD.
SELANGOR DARUL EHSAN,  MY.
Contract Manufacturer;  
TEXSTRIP MANUFACTURING SDN. BHD.
SELANGOR DARUL EHSAN,  MY.
TEXTIL ELASTICO S.A.
ALPICAT (LLEIDA),  SP.
Unregistered Foreign Lister;  
TEXTIL ELASTICO S.A.
ALPICAT (LLEIDA),  SP.
TEXTILE NETWORK CONCEPTS, INC.
GREENSBORO,  NC,  US.
Initial Importer;  
TEXTILE NETWORK CONCEPTS, INC.
GREENSBORO,  NC ,  US.
TEXTILES LOS ROSALES S.A.C.
LIMA,  PE.
Manufacturer;  
TEXTILES LOS ROSALES S.A.C.
LIMA,  PE.
TEXTUS INDUSTRIES, INC.
PEORIA,  IL,  US.
Initial Importer;   Specification Developer;  
TEXTUS INDUSTRIES, INC.
PEORIA,  IL ,  US.

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Last Modified: 29 April 2006
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