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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
TELEGENIX, INC.
CHERRY HILL,  NJ,  US.
Contract Manufacturer;  
TELEGENIX, INC.
CHERRY HILL,  NJ ,  US.
TELEHEALTH BROADBAND, LLC
AUSTIN,  TX,  US.
Specification Developer;  
TELEHEALTH BROADBAND, LLC
AUSTIN,  TX ,  US.
TELELINK COMMUNICATIONS, INC.
AURORA,  CO,  US.
Initial Importer;  
TELELINK COMMUNICATIONS, INC.
AURORA,  CO ,  US.
TELE-MADE DISPOSABLES, INC.
HUFFMAN,  TX,  US.
Contract Manufacturer;   Manufacturer;  
TELE-MADE DISPOSABLES, INC.
HUFFMAN,  TX ,  US.
TELEMED SYSTEMS, INC.
HUDSON,  MA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
TELEMED SYSTEMS, INC.
HUDSON,  MA ,  US.
TELEMIS S.A.
LOUVAIN-LA-NEUVE,  BE.
Manufacturer;  
TELEMIS S.A.
LOUVAIN-LA-NEUVE,  BE.
TELEPHONICS CORP.
HUNTINGTON,  NY,  US.
Contract Manufacturer;  
TELEPHONICS CORP.
HUNTINGTON,  NY ,  US.
TELESENSORY CORP.
SUNNYVALE,  CA,  US.
Manufacturer;   Specification Developer;  
TELESENSORY CORP.
SUNNYVALE,  CA ,  US.
TELEVERE SYSTEMS
LOS GATOS,  CA,  US.
Manufacturer;  
TELEVERE SYSTEMS
LOS GATOS,  CA ,  US.
TELEVITAL, INC.
SAN JOSE,  CA,  US.
Manufacturer;  
TELEVITAL, INC.
SAN JOSE,  CA ,  US.
TELEX COMMUNICATIONS
LINCOLN,  NE,  US.
Manufacturer;  
TELEX COMMUNICATIONS, INC.
BURNSVILLE,  MN ,  US.
TELINJECT U.S.A., INC.
AGUA DULCE,  CA,  US.
Initial Importer;  
TELINJECT U.S.A., INC.
AGUA DULCE,  CA ,  US.
TELLA-TECH, INC.
PEMBROKE PARK,  FL,  US.
Specification Developer;  
TELLA-TECH, INC.
PEMBROKE PARK,  FL ,  US.
TELLUS MEDICAL PRODUCTS, INC.
PALM DESERT,  CA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
TELLUS MEDICAL PRODUCTS, INC.
PALM DESERT,  CA ,  US.
TELSAR LABORATORIES, INC.
WOOD RIVER,  IL,  US.
Initial Importer;   Manufacturer;  
TELSAR LABORATORIES, INC.
WOOD RIVER,  IL ,  US.
TELSTAR INNOVATIONS, INC.
OAKFORD,  PA,  US.
Initial Importer;  
TELSTAR INNOVATIONS, INC.
OAKFORD,  PA ,  US.
TEMEC INSTRUMENTS B.V.
KERKRADE,  NL.
Manufacturer;  
TEMEC INSTRUMENTS B.V.
KERKRADE,  NL.
TEMEDCO, LTD.
SAN ANTONIO,  TX,  US.
Manufacturer;  
TEMEDCO, LTD.
SAN ANTONIO,  TX ,  US.
TEMOOR AHMAD
SIALKOT,  PK.
Unregistered Foreign Lister;  
TEMOOR AHMAD
SIALKOT,  PK.
TEMPEST LABS., INC.
PHILADELPHIA,  PA,  US.
Initial Importer;  
TEMPEST LABS., INC.
PHILADELPHIA,  PA ,  US.
TEMPLAB
SCOTTSDALE,  AZ,  US.
Initial Importer;  
TEMPLAB
SCOTTSDALE,  AZ ,  US.
TEMPO WHOLESALE MEDICAL, LLC.
SCOTTSDALE,  AZ,  US.
Initial Importer;  
TEMPO WHOLESALE MEDICAL, LLC.
SCOTTSDALE,  AZ ,  US.
TEMP-TRONIX
SAN DIEGO,  CA,  US.
Manufacturer;  
TEMP-TRONIX
SAN DIEGO,  CA ,  US.
TEMPUR PRODUCTION USA, INC.
DUFFIELD,  VA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
TEMPUR-PEDIC, INC.
LEXINGTON,  KY ,  US.
TEMPUR-PEDIC MEDICAL,INC.
LEXINGTON,  KY,  US.
Specification Developer;  
TEMPUR-PEDIC, INC.
LEXINGTON,  KY ,  US.
TEMREX CORP.
FREEPORT,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
TEMREX CORP.
FREEPORT,  NY ,  US.
TEN COMFORT CORP.
YUNG-HO CITY, TAIPEI,  CH.
Manufacturer;  
TEN COMFORT CORP.
YUNG-HO CITY, TAIPEI,  CH.
TENACORE HOLDINGS, INC.
SANTA ANA,  CA,  US.
Contract Manufacturer;   Manufacturer;  
TENACORE HOLDINGS, INC.
SANTA ANA,  CA ,  US.
TENDA PLASTIC MFY. LTD.
KWUN TONG, KOWLOON,  HK.
Manufacturer;  
TENDA PLASTIC MFY. LTD.
KWUN TONG, KOWLOON,  HK.
TEND-A-FOOT, INC.
TULSA,  OK,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
TEND-A-FOOT, INC.
TULSA,  OK ,  US.
TENDASOFT, INC.
VAN WERT,  OH,  US.
Manufacturer;  
TENDASOFT, INC.
VAN WERT,  OH ,  US.
TENDER CARE PRODUCTS, INC.
GRANITE FALLS,  NC,  US.
Specification Developer;  
TENDER CARE PRODUCTS, INC.
GRANITE FALLS,  NC ,  US.
TENDLETON INTL. CO.
PASADENA,  CA,  US.
Initial Importer;  
TENDLETON INTL. CO.
PASADENA,  CA ,  US.
TENERCO
NEWPORT BEACH,  CA,  US.
Initial Importer;  
TENERCO
NEWPORT BEACH,  CA ,  US.
TENET MEDICAL ENGINEERING
CALGARY, AB,  CA.
Manufacturer;  
TENET MEDICAL ENGINEERING
CALGARY, AB,  CA.
TENG FEI TRADING INC.
FLUSHING,  NY,  US.
Initial Importer;  
TENG FEI TRADING INC.
FLUSHING,  NY ,  US.
TENG WANG CO., LTD.
CHANGHUA COUNTY,  TW.
Repackager/Relabeller;  
TENG WANG CO., LTD.
CHANGHUA COUNTY,  TW.
TENHAI SHINYEH CO., LTD.
TAIPEI,  TW.
Specification Developer;  
TENHAI SHINYEH CO., LTD.
TAIPEI,  TW.
TENIN OPTICAL MFG., LTD.
DONGGUAN, GUANGDONG,  CH.
Manufacturer;  
TENIN OPTICAL MFG., LTD.
DONGGUAN, GUANGDONG,  CH.
TENIN OPTICAL MFG., LTD.
NEW TERRITORIES,  HK.
Manufacturer;  
TENIN OPTICAL MFG., LTD.
NEW TERRITORIES,  HK.

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Last Modified: 29 April 2006
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