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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
UNITED TOWEL EXPORTERS
KARACHI,  PK.
Manufacturer;  
UNITED TOWEL EXPORTERS
KARACHI,  PK.
UNITED VISION OF NEW YORK CORPORATION
HEMPSTEAD,  NY,  US.
Initial Importer;  
UNITED VISION OF NEW YORK CORPORATION
HEMPSTEAD,  NY ,  US.
UNITED YORAM DISTRIBUTORS, INC.
BROOKLYN,  NY,  US.
Initial Importer;   Specification Developer;  
UNITED YORAM DISTRIBUTORS, INC.
BROOKLYN,  NY ,  US.
UNITED-GUARDIAN, INC.
HAUPPAUGE,  NY,  US.
Contract Manufacturer;   Manufacturer;  
UNITED-GUARDIAN, INC.
HAUPPAUGE,  NY ,  US.
UNITIME IMPORTS, INC.
SPOKANE,  WA,  US.
Initial Importer;  
UNITIME IMPORTS, INC.
SPOKANE,  WA ,  US.
UNITRADE CO.
SAN GABRIEL,  CA,  US.
Initial Importer;  
ARTHUR W. CHEN
SAN GABRIEL,  CA ,  US.
UNITRON HEARING
PYLMOUTH,  MN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;  
UNITRON HEARING
PLYMOUTH,  MN ,  US.
UNITRON HEARING (SUZHOU) CO., LTD.
JIANGSU,  CH.
Foreign Exporter;   Manufacturer;   Specification Developer;  
UNITRON HEARING (SUZHOU) CO., LTD.
JIANGSU,  CH.
UNITRON HEARING LTD.
KITCHENER, ONTARIO,  CA.
Foreign Exporter;   Manufacturer;   Specification Developer;  
UNITRON HEARING LTD.
KITCHENER, ONTARIO,  CA.
UNITY TOOL, INC.
DAYTON,  MN,  US.
Contract Manufacturer;  
UNITY TOOL, INC.
DAYTON,  MN ,  US.
UNIVAC DENTAL CO.
WARMINSTER,  PA,  US.
Initial Importer;  
UNIVAC DENTAL CO.
WARMINSTER,  PA ,  US.
UNIVAC PRECISION PLASTICS (SHANGHAI) CO., LTD.
SHANGHAI,  CH.
Manufacturer;  
UNIVAC PRECISION ENGINEERING PTE.LTD.
SINGAPORE,  SN.
UNIVEC, INC.
BALTIMORE,  MD,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
UNIVEC, INC.
BALTIMORE,  MD ,  US.
UNIVERSAL APPLIANCES LTD.
KWUN TONG,  HK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
UNIVERSAL APPLIANCES LTD.
KWUN TONG,  HK.
UNIVERSAL BRANDS CORP.
TENAFLY,  NJ,  US.
Initial Importer;  
UNIVERSAL BRANDS CORP.
TENAFLY,  NJ ,  US.
UNIVERSAL BRANDS LLC.
SOUTHFIELD,  MI,  US.
Initial Importer;  
UNIVERSAL BRANDS LLC.
SOUTHFIELD,  MI ,  US.
UNIVERSAL CARE CORP.
HATO TEJAS,  PR,  US.
Initial Importer;  
UNIVERSAL CARE CORP.
HATO TEJAS,  PR ,  US.
UNIVERSAL COMPANIES INC.
ABINGDON,  VA,  US.
Initial Importer;   Specification Developer;  
UNIVERSAL COMPANIES INC.
ABINGDON,  VA ,  US.
UNIVERSAL COMPLEX HAWAII, INC.
HONOLULU,  HI,  US.
Repackager/Relabeller;  
UNIVERSAL COMPLEX HAWAII, INC.
HONOLULU,  HI ,  US.
UNIVERSAL CONCEPTS LTD. (UK)
GREATER MANCHESTER,  UK.
Specification Developer;   Repackager/Relabeller;  
THE CHARACTER GROUP PLC
SURREY,  UK.
UNIVERSAL DME, LLC
ALBANY,  GA,  US.
Initial Importer;  
UNIVERSAL DME, LLC
ALBANY,  GA ,  US.
UNIVERSAL ELECTRONICS, INC.
HELENVILLE,  WI,  US.
Contract Manufacturer;  
UNIVERSAL ELECTRONICS, INC.
WHITEWATER,  WI ,  US.
UNIVERSAL ELECTRONICS, INC.
WHITEWATER,  WI,  US.
Contract Manufacturer;  
UNIVERSAL ELECTRONICS, INC.
WHITEWATER,  WI ,  US.
UNIVERSAL ENTERPRISE CO.
SAN JOSE,  CA,  US.
Initial Importer;  
JOE WU
SAN JOSE,  CA ,  US.
UNIVERSAL EXPORT & IMPORT, INC.
DARIEN,  IL,  US.
Initial Importer;  
UNIVERSAL EXPORT & IMPORT, INC.
DARIEN,  IL ,  US.
UNIVERSAL FOOTCARE PRODUCTS, INC.
NORTHBROOK,  IL,  US.
Initial Importer;  
UNIVERSAL HOLDINGS, INC.
NORTHBROOK,  IL ,  US.
UNIVERSAL GLOVES CORP.
SHIN YING, TAINAN HSIEN,  TW.
Manufacturer;  
UNIVERSAL GLOVES CORP.
SHIN YING, TAINAN HSIEN,  TW.
UNIVERSAL GLOVES PRIVATE LTD.
KOCHI, KERALA,  IN.
Manufacturer;  
UNIVERSAL GLOVES PRIVATE LTD.
KOCHI, KERALA,  IN.
UNIVERSAL HOME HEALTH & INDUSTRIAL SUPPLIES, INC.
TAMPA,  FL,  US.
Initial Importer;  
UNIVERSAL HOME HEALTH & INDUSTRIAL SUPPLIES, INC.
TAMPA,  FL ,  US.
UNIVERSAL IMPLANT SYSTEMS, INC.
WASHINGTON,  DC,  US.
Specification Developer;   Repackager/Relabeller;  
UNIVERSAL IMPLANT SYSTEMS, INC.
WASHINGTON,  DC ,  US.
UNIVERSAL JOINT INTERNATIONAL CO., LTD.
TAIPEI,  TW.
Manufacturer;   Specification Developer;  
MEDTECS (TAIWAN) CORP.
TAIPEI,  TW.
UNIVERSAL LATEX ENT.
PARSIPPANY,  NJ,  US.
Initial Importer;  
UNIVERSAL LATEX ENT.
PARSIPPANY,  NJ ,  US.
UNIVERSAL LATEX PRODUCTS CO., LTD.
BANGPLEE, SAMUTPRAKARN,  TH.
Manufacturer;  
UNIVERSAL LATEX PRODUCTS CO., LTD.
BANGPLEE, SAMUTPRAKARN,  TH.
UNIVERSAL LINEN
KARACHI,  PK.
Unregistered Foreign Lister;  
UNIVERSAL LINEN
KARACHI,  PK.
UNIVERSAL MARINE MEDICAL SUPPLY CO.
BROOKLYN,  NY,  US.
Initial Importer;  
UNIVERSAL MARINE MEDICAL SUPPLY CO.
BROOKLYN,  NY ,  US.
UNIVERSAL MEDICAL DISTRIBUTORS, INC.
CORAL GABLES,  FL,  US.
Initial Importer;  
UNIVERSAL MEDICAL DISTRIBUTORS, INC.
CORAL GABLES,  FL ,  US.
UNIVERSAL MEDICAL PRODUCTS
CULVER CITY,  CA,  US.
Repackager/Relabeller;  
UNIVERSAL MEDICAL PRODUCTS
CULVER CITY,  CA ,  US.
UNIVERSAL MEDICAL PRODUCTS, INC.
HAZEL CREST,  IL,  US.
Initial Importer;  
UNIVERSAL MEDICAL PRODUCTS, INC.
ORLAND PARK,  IL ,  US.
UNIVERSAL MEDICAL PRODUCTS, INC.
VINELAND,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
UNIVERSAL MEDICAL PRODUCTS, INC.
VINELAND,  NJ ,  US.
UNIVERSAL MEDICAL SERVICES, INC.
BEAVER FALLS,  PA,  US.
Initial Importer;  
UNIVERSAL MEDICAL SERVICES, INC.
BEAVER FALLS,  PA ,  US.

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Last Modified: 29 April 2006
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