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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
SPIGGLE & THEIS MEDIZINTECHNIK GMBH
OVERATH,  GM.
Manufacturer;  
SPIGGLE & THEIS MEDIZINTECHNIK GMBH
OVERATH,  GM.
SPILL-GUARD LLC
ARLINGTON,  VA,  US.
Specification Developer;  
SPILL-GUARD LLC
ARLINGTON,  VA ,  US.
SPINA DENTAL SUPPLIES
PITTSBURGH,  PA,  US.
Initial Importer;  
SPINA DENTAL SUPPLIES
PITTSBURGH,  PA ,  US.
SPINAL & ORTHOPEDIC DEVICES, INC.
VAN NUYS,  CA,  US.
Specification Developer;  
SPINAL & ORTHOPEDIC DEVICES, INC.
VAN NUYS,  CA ,  US.
SPINAL DESIGNS INTL.
MINNEAPOLIS,  MN,  US.
Specification Developer;  
SPINAL DESIGNS INTL.
MINNEAPOLIS,  MN ,  US.
SPINAL INNOVATIONS, INC.
BARTLETT,  TN,  US.
Specification Developer;  
SPINAL INNOVATIONS, INC.
BARTLETT,  TN ,  US.
SPINAL KINETICS, INC.
REDWOOD CITY,  CA,  US.
Manufacturer;  
SPINAL KINETICS, INC.
REDWOOD CITY,  CA ,  US.
SPINAL SOLUTIONS, INC.
CONYERS,  GA,  US.
Manufacturer;  
SPINAL SOLUTIONS, INC.
CONYERS,  GA ,  US.
SPINAL SOLUTIONS, LLC
MURRIETA,  CA,  US.
Initial Importer;  
SPINAL SOLUTIONS, LLC
MURRIETA,  CA ,  US.
SPINAL SPECIALTIES, INC.
SAN ANTONIO,  TX,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
SPINAL TECHNOLOGIES INC
W.YARMOUTH,  MA,  US.
Manufacturer;  
SPINAL TECHNOLOGIES INC
W.YARMOUTH,  MA ,  US.
SPINAL TRACTION PRODUCTS, LLC.
ST. CHARLES,  MO,  US.
Manufacturer;  
SPINAL TRACTION PRODUCTS, LLC.
ST. CHARLES,  MO ,  US.
SPINAL-GLIDE
SAN FRANCISCO,  CA,  US.
Initial Importer;  
SPINAL-GLIDE
SAN FRANCISCO,  CA ,  US.
SPINE WAVE, INC.
SHELTON,  CT,  US.
Specification Developer;  
SPINE WAVE, INC.
SHELTON,  CT ,  US.
SPINECRAFT, INC.
ELMHURST,  IL,  US.
Specification Developer;  
SPINECRAFT, INC.
ELMHURST,  IL ,  US.
SPINE-ISSIMUS LTD.
WENDENS AMBO,  UK.
Manufacturer;  
SPINE-ISSIMUS LTD.
WENDENS AMBO,  UK.
SPINEOLOGY, INC.
ST. PAUL,  MN,  US.
Specification Developer;  
SPINEOLOGY, INC.
ST. PAUL,  MN ,  US.
SPINERX TECHNOLOGY
HOUSTON,  TX,  US.
Manufacturer;  
SPINERX TECHNOLOGY
HOUSTON,  TX ,  US.
SPINEVISION, INC.
ATLANTA,  GA,  US.
Initial Importer;  
SPINEVISION, S.A.
PARIS,  FR.
SPINEVISION, S.A.
PARIS,  FR.
Manufacturer;   Specification Developer;  
SPINEVISION, S.A.
PARIS,  FR.
SPINEWORKS, LLC
HUNTINGTON BEACH,  CA,  US.
Specification Developer;  
SPINEWORKS, LLC
HUNTINGTON BEACH,  CA ,  US.
SPINEX MEDICAL CORP. OF AMERICA
NORTH TROY,  VT,  US.
Initial Importer;  
SPINEX MEDICAL TECHNOLOGIES, INC.
MONTREAL, QUEBEC,  CA.
SPINUS, LLC
HAMPTON,  NH,  US.
Manufacturer;  
SPINUS, LLC
HAMPTON,  NH ,  US.
SPIRACLE TECHNOLOGY
FOUNTAIN VALLEY,  CA,  US.
Manufacturer;  
SPIRACLE TECHNOLOGY
FOUNTAIN VALLEY,  CA ,  US.
SPIRE BIOMEDICAL, INC.
BEDFORD,  MA,  US.
Specification Developer;  
SPIRE BIOMEDICAL, INC.
BEDFORD,  MA ,  US.
SPIROMETRICS MEDICAL EQUIPMENT COMPANY, LLC
GRAY,  ME,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SPIROMETRICS MEDICAL EQUIPMENT COMPANY, LLC
GRAY,  ME ,  US.
SPITFIRE SUNGLASS DESIGN USA INC.
CHICAGO,  IL,  US.
Initial Importer;  
SPITFIRE SUNGLASS DESIGN USA INC.
CHICAGO,  IL ,  US.
SPIVEY INTL., INC.
SAN FRANCISCO,  CA,  US.
Initial Importer;  
SPIVEY INTL., INC.
SAN FRANCISCO,  CA ,  US.
SPLASH MEDICAL DEVICES, LLC
ATLANTA,  GA,  US.
Initial Importer;   Specification Developer;  
SPLASH MEDICAL DEVICES, LLC
ATLANTA,  GA ,  US.
SPLASH SHIELD, INC.
WOBURN,  MA,  US.
Manufacturer;   Specification Developer;  
SPLASH SHIELD, INC.
WOBURN,  MA ,  US.
SPLENDID TRADING INC.
MIAMI,  FL,  US.
Initial Importer;  
SPLENDID TRADING INC.
MIAMI,  FL ,  US.
SPLENODEX CANADA, INC.
STE-ANNE DES LACS, QUEBEC,  CA.
Specification Developer;  
L.R.T. SPLENODEX S.A.
ST. FARGEAU, PONTHIERRY,  FR.
SPM, INC.
GEORGETOWN,  TX,  US.
Contract Manufacturer;  
SPM, INC.
GEORGETOWN,  TX ,  US.
SPOMA INTL. CORP.
TAIPEI,  TW.
Manufacturer;  
SPOMA INTL. CORP.
TAIPEI,  TW.
SPORA MEDICAL
VAULX EN VELIN,  FR.
Manufacturer;  
MAX PATISSIER
LYON,  FR.
SPORICIDIN INTL.
ROCKVILLE,  MD,  US.
Specification Developer;  
SPORICIDIN INTL.
ROCKVILLE,  MD ,  US.
SPORLASTIC GMBH
NURTINGEN,  GM.
Manufacturer;  
SPORLASTIC GMBH
NURTINGEN,  GM.
SPOROPTIC POUILLOUX, SA
PARIS,  FR.
Unregistered Foreign Lister;  
SPOROPTIC POUILLOUX, SA
PARIS,  FR.
SPORT APPAREL, S.A. DE C.V.
GOMEZ PALACIO, DURANGO,  MX.
Contract Manufacturer;  
SPORT APPAREL, S.A. DE C.V.
GOMEZ PALACIO, DURANGO,  MX.
SPORT GLOVE MFG., INC.
EATON PARK,  FL,  US.
Initial Importer;  
SPORT GLOVE MFG., INC.
EATON PARK,  FL ,  US.

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Last Modified: 29 April 2006
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