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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
ULTRA SUN USA INC.
INDIANAPOLIS,  IN,  US.
Initial Importer;  
ULTRA SUN USA INC.
INDIANAPOLIS,  IN ,  US.
ULTRA SURGICO
SIALKOT,  PK.
Manufacturer;  
ULTRA SURGICO
SIALKOT,  PK.
ULTRABRONZ AMERICA, INC.
RICHMOND,  VA,  US.
Initial Importer;  
ULTRABRONZ AMERICA, INC.
RICHMOND,  VA ,  US.
ULTRACELL MEDICAL TECHNOLOGIES OF CONNECTICUT, INC
NORTH STONINGTON,  CT,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
ULTRACELL MEDICAL TECHNOLOGIES OF CONNECTICUT, INC
NORTH STONINGTON,  CT ,  US.
ULTRA-COATING-AG
URDORF,  SZ.
Contract Manufacturer;  
RAPID-HOLDING AG
DIETIKON,  SZ.
ULTRADENT PRODUCTS, INC.
SOUTH JORDAN,  UT,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ULTRADENT PRODUCTS, INC.
SOUTH JORDAN,  UT ,  US.
ULTRA-DERM SYSTEMS
SAGINAW,  MI,  US.
Manufacturer;  
J & B PRODUCTS, LTD.
SAGINAW,  MI ,  US.
ULTRAFLEX INTERNATIONAL INC.
RONKONKOMA,  NY,  US.
Initial Importer;  
ULTRAFLEX INTERNATIONAL INC.
RONKONKOMA,  NY ,  US.
ULTRAFLEX SYSTEMS, INC.
POTTSTOWN,  PA,  US.
Manufacturer;   Specification Developer;  
ULTRAFLEX SYSTEMS, INC.
POTTSTOWN,  PA ,  US.
ULTRALIGHT LASER SYSTEMS, LLC
BIRMINGHAM,  AL,  US.
Specification Developer;  
ULTRALIGHT LASER SYSTEMS, LLC
BIRMINGHAM,  AL ,  US.
ULTRALITE ENT., INC.
LAWRENCEVILLE,  GA,  US.
Manufacturer;  
ULTRALITE ENT., INC.
LAWRENCEVILLE,  GA ,  US.
ULTRAMAX INDUSTRIES INC.
BLOOMINGDALE,  IL,  US.
Initial Importer;  
ULTRAMAX INDUSTRIES INC.
BLOOMINGDALE,  IL ,  US.
ULTRAMED
DIAMOND BAR,  CA,  US.
Initial Importer;  
ULTRAMED
DIAMOND BAR,  CA ,  US.
ULTRAMEDIC LTD.
LIVERPOOL,  UK.
Manufacturer;  
ULTRAMEDIC LTD.
LIVERPOOL,  UK.
ULTRAPLAST
PETACH TIKVA,  IS.
Unregistered Foreign Lister;  
ULTRAPLAST
PETACH TIKVA,  IS.
ULTRAPURE LABS, INC.
SITTINGBOURNE,  UK.
Manufacturer;  
ULTRAPURE LABS, INC.
SITTINGBOURNE,  UK.
ULTRASCOPE, INC.
CHARLOTTE,  NC,  US.
Manufacturer;  
ULTRASCOPE, INC.
CHARLOTTE,  NC ,  US.
ULTRASKIN CORP.
CHULA VISTA,  CA,  US.
Initial Importer;  
ULTRASKIN CORP.
CHULA VISTA,  CA ,  US.
ULTRASOL
TORRANCE,  CA,  US.
Initial Importer;  
ULTRASOL
TORRANCE,  CA ,  US.
ULTRASONIC TECHNOLOGIES LTD.
GYEONBUK,  KS.
Manufacturer;  
SIEMENS MEDICAL SOLUTIONS USA, INC.
MALVERN,  PA ,  US.
ULTRASONIC TECHNOLOGIES, LTD.
GANGWON-DO,  KS.
Manufacturer;  
SIEMENS MEDICAL SOLUTIONS USA, INC.
MALVERN,  PA ,  US.
ULTRASONIX MEDICAL CORPORATION
BURNABY, BRITISH COLUMBIA,  CA.
Manufacturer;  
ULTRASONIX MEDICAL CORPORATION
BURNABY, BRITISH COLUMBIA,  CA.
ULTRASOUND TECHNOLOGIES LTD.
CALDICOT, MONMOUTHSHIRE,  UK.
Manufacturer;   Specification Developer;  
ULTRASOUND TECHNOLOGIES LTD.
GWENT,  UK.
ULTRASPECT INC.
OCONOMOWOC,  WI,  US.
Initial Importer;  
ULTRASPECT LTD.
HAIFA,  IS.
ULTRASPECT LTD.
HAIFA,  IS.
Manufacturer;  
ULTRASPECT LTD.
HAIFA,  IS.
ULTRASSAGE, INC.
MONTREAL, QUEBEC,  CA.
Manufacturer;  
ULTRASSAGE, INC.
MONTREAL, QUEBEC,  CA.
ULTRATAN SUNTANNING CENTERS, INC.
LYNBROOK,  NY,  US.
Initial Importer;  
ULTRATAN SUNTANNING CENTERS, INC.
LYNBROOK,  NY ,  US.
ULTRAVOICE, LTD.
NEWTOWN SQUARE,  PA,  US.
Manufacturer;  
ULTRAVOICE, LTD.
NEWTOWN SQUARE,  PA ,  US.
ULTRAWAVE LTD.
CARDIFF, WALES,  UK.
Manufacturer;  
ULTRAWAVE LTD.
CARDIFF, WALES,  UK.
ULTRAWIN SDN BHD
CHEMOR, PERAK,  MY.
Manufacturer;  
ULTRAWIN SDN BHD
CHEMOR, PERAK,  MY.
ULTREX PODIATRIC LABORATORIES
HOBBEMA, AB,  CA.
Manufacturer;  
ULTREX PODIATRIC LABORATORIES
HOBBEMA, AB,  CA.
ULTROID TECHNOLOGIES, INCORPORATED
ST. PETERSBURG,  FL,  US.
Manufacturer;  
ULTROID TECHNOLOGIES, INCORPORATED
ST. PETERSBURG,  FL ,  US.
U-MARC, INC.
LIBERTYVILLE,  IL,  US.
Manufacturer;  
U-MARC, INC.
LIBERTYVILLE,  IL ,  US.
UMBRA MEDICAL CORP.
INVERNESS,  FL,  US.
Initial Importer;  
UMBRA MEDICAL CORP.
INVERNESS,  FL ,  US.
UMC INC.
MONTICELLO,  MN,  US.
Contract Manufacturer;  
UMC INC.
MONTICELLO,  MN ,  US.
UMECO UNION MEDICAL ENGINEERING
SEOUL,  KS.
Unregistered Foreign Lister;   Manufacturer;  
UMECO UNION MEDICAL ENGINEERING
SEOUL,  KS.
UMECO, INC.
SAN JUAN,  PR,  US.
Initial Importer;  
UMECO, INC.
SAN JUAN,  PR ,  US.
UMED CORPORATION
BARTLETT,  IL,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
UMED CORPORATION
BARTLETT,  IL ,  US.
UMEDA INC.
IMADATE-GUN, FUKUI-PREF,  JA.
Manufacturer;  
UMEDA INC.
IMADATE-GUN, FUKUI-PREF,  JA.
UMI INTL.
NORWOOD,  NJ,  US.
Initial Importer;   Specification Developer;  
UMI INTL.
NORWOOD,  NJ ,  US.

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Last Modified: 29 April 2006
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