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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
SPECIALTY TINT
ESCONDIDO,  CA,  US.
Manufacturer;  
SPECIALTY TINT
ESCONDIDO,  CA ,  US.
SPECLINC
DYERSBURG,  TN,  US.
Manufacturer;  
SPECLINC
DYERSBURG,  TN ,  US.
SPECMAT TECHNOLOGIES INC.
ROCKFORD,  TN,  US.
Manufacturer;  
SPECMAT LTD.
HEREFORDSHIRE,  UK.
SPECS 2C, LLC
NANYON,  EC.
Manufacturer;  
SPECS 2C, LLC
HOLLYWOOD,  FL ,  US.
SPECS 2C, LLC
HOLLYWOOD,  FL,  US.
Contract Manufacturer;  
SPECS 2C, LLC
HOLLYWOOD,  FL ,  US.
SPECS OF FAIRFIELD
FAIRFIELD,  CT,  US.
Initial Importer;  
SPECS OF FAIRFIELD
FAIRFIELD,  CT ,  US.
SPECTACLE EYEWORKS INC.
VANCOUVER, BC,  CA.
Specification Developer;  
SPECTACLE EYEWORKS INC.
VANCOUVER, BC,  CA.
SPECTACLE SHOP, INC.
CHARLOTTESVILLE,  VA,  US.
Initial Importer;  
SPECTACLE SHOP, INC.
CHARLOTTESVILLE,  VA ,  US.
SPECTACLE SHOPPE, INC.
NEW BRIGHTON,  MN,  US.
Initial Importer;  
SPECTACLE SHOPPE, INC.
NEW BRIGHTON,  MN ,  US.
SPECTACULAR PRODUCTS, INC.
SHIRLEY,  MA,  US.
Initial Importer;   Repackager/Relabeller;  
SPECTACULAR PRODUCTS, INC.
SHIRLEY,  MA ,  US.
SPECTERA, INC.
BALTIMORE,  MD,  US.
Initial Importer;   Specification Developer;  
SPECTERA, INC.
BALTIMORE,  MD ,  US.
SPECTRA GROUP, INC.
PALM DESERT,  CA,  US.
Initial Importer;  
SPECTRA GROUP, INC.
PALM DESERT,  CA ,  US.
SPECTRA INDUSTRIES CORP.
YEADON,  PA,  US.
Manufacturer;  
SPECTRA INDUSTRIES CORP.
YEADON,  PA ,  US.
SPECTRA ITALY SRL
BIASSONO, MILANO,  IT.
Unregistered Foreign Lister;  
SPECTRA ITALY SRL
BIASSONO, MILANO,  IT.
SPECTRA MEDICAL DEVICES
WOBURN,  MA,  US.
Initial Importer;  
SPECTRA MEDICAL DEVICES
WOBURN,  MA ,  US.
SPECTRA MERCHANDISING INTERNATIONAL, INC.
CHICAGO,  IL,  US.
Initial Importer;  
SPECTRA MERCHANDISING INTERNATIONAL, INC.
CHICAGO,  IL ,  US.
SPECTRAGENICS, INC.
PLEASANTON,  CA,  US.
U.S. Manufacturer of Export Only Devices;
SPECTRAGENICS, INC.
PLEASANTON,  CA ,  US.
SPECTRAL DIAGNOSTICS INC. USA
WHITESTONE,  VA,  US.
Initial Importer;  
SPECTRAL DIAGNOSTICS, INC.
TORONTO, ONTARIO,  CA.
SPECTRAL DIAGNOSTICS, INC.
TORONTO, ONTARIO,  CA.
Manufacturer;   Specification Developer;  
SPECTRAL DIAGNOSTICS, INC.
TORONTO, ONTARIO,  CA.
SPECTRAL FUSION TECHNOLOGIES LLC
ALPHARETTA,  GA,  US.
Initial Importer;  
SPECTRAL FUSION TECHNOLOGIES LTD.
COLESHILL, BIRMINGHAM,  UK.
SPECTRAL VISUALIZATION & DEVELOPMENT, INC.
FREDERICTON, NEW BRUNSWICK,  CA.
Manufacturer;  
SPECTRAL VISUALIZATION & DEVELOPMENT, INC.
FREDERICTON, NEW BRUNSWICK,  CA.
SPECTRAMED, INC.
LEWIS CENTER,  OH,  US.
Initial Importer;  
SPECTRAMED, INC.
MOUNT VERNON,  OH ,  US.
SPECTRANETICS CORP.
COLORADO SPRINGS,  CO,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Contract Sterilizer;  
SPECTRANETICS CORP.
COLORADO SPRINGS,  CO ,  US.
SPECTRASCIENCE, INC.
SAN DIEGO,  CA,  US.
Manufacturer;   Specification Developer;  
SPECTRASCIENCE, INC.
SAN DIEGO,  CA ,  US.
SPECTRA-TINT
ROCHESTER,  NY,  US.
Manufacturer;  
SPECTRA-TINT
ROCHESTER,  NY ,  US.
SPECTRON COSMETICS LIMITED
RUGBY WARWICKSHIRE,  UK.
Repackager/Relabeller;  
SPECTRON COSMETICS LIMITED
RUGBY WARWICKSHIRE,  UK.
SPECTRON LASER SYSTEMS LTD.
RUGBY, WARWICKSHIRE,  UK.
Manufacturer;  
SPECTRON LASER SYSTEMS LTD.
RUGBY, WARWICKSHIRE,  UK.
SPECTRONICS CORP.
WESTBURY,  NY,  US.
Manufacturer;  
SPECTRONICS CORP.
WESTBURY,  NY ,  US.
SPECTROS CORPORATION
PORTOLA VALLEY,  CA,  US.
Specification Developer;  
SPECTROS CORPORATION
PORTOLA VALLEY,  CA ,  US.
SPECTRUM AEROMED, INC.
WHEATON,  MN,  US.
Manufacturer;  
SPECTRUM AEROMED, INC.
WHEATON,  MN ,  US.
SPECTRUM BIOSYSTEMS
ST CHARLES,  IL,  US.
Initial Importer;  
SPECTRUM BIOSYSTEMS
ST. CHARLES,  IL ,  US.
SPECTRUM BRANDS, INC.
MADISON,  WI,  US.
Specification Developer;  
SPECTRUM BRANDS, INC.
MADISON,  WI ,  US.
SPECTRUM DENTAL INC.
CULVER CITY,  CA,  US.
Manufacturer;  
SPECTRUM DENTAL INC.
CULVER CITY,  CA ,  US.
SPECTRUM DESIGNS, INC.
CARPINETERIA,  CA,  US.
Manufacturer;  
SPECTRUM DESIGNS, INC.
CARPINETERIA,  CA ,  US.
SPECTRUM ENVIRONMENTAL TECHNOLOGIES, INC.
FOLSOM,  CA,  US.
Contract Sterilizer;  
SPECTRUM ENVIRONMENTAL TECHNOLOGIES, INC.
FOLSOM,  CA ,  US.
SPECTRUM HEARING SYSTEMS, INC.
CORNELIUS,  NC,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
SPECTRUM HEARING SYSTEMS, INC.
CORNELIUS,  NC ,  US.
SPECTRUM INTERNATIONAL
CINCINNATI,  OH,  US.
Initial Importer;  
SPECTRUM INTERNATIONAL
CINCINNATI,  OH ,  US.
SPECTRUM INTERNATIONAL DENTAL SERVICES
HOUSTON,  TX,  US.
Repackager/Relabeller;  
SPECTRUM INTERNATIONAL DENTAL SERVICES
HOUSTON,  TX ,  US.
SPECTRUM LABORATORIES, INC.
RANCHO DOMINGUEZ,  CA,  US.
Contract Manufacturer;   Manufacturer;  
SPECTRUM LABORATORIES, INC.
RANCHO DOMINGUEZ,  CA ,  US.
SPECTRUM LASER & TECHNOLOGIES, INC.
COLORADO SPRINGS,  CO,  US.
Contract Manufacturer;  
SPECTRUM LASER & TECHNOLOGIES, INC.
COLORADO SPRINGS,  CO ,  US.

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Last Modified: 29 April 2006
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