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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
INPHARMA, INC.
BOSTON,  MA,  US.
Initial Importer;  
INPHARMA A.S.
DRAMMEN,  NO.
INRAD
KENTWOOD,  MI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INRAD
KENTWOOD,  MI ,  US.
INREACH CORPORATION
ANDERSON,  SC,  US.
Manufacturer;  
INREACH CORPORATION
ANDERSON,  SC ,  US.
INRO MEDICAL DESIGNS, INC.
DESOTO,  TX,  US.
Initial Importer;  
INRO MEDICAL DESIGNS, INC.
DESOTO,  TX ,  US.
INSEAT SOLUTIONS, LLC
SANTA FE SPRINGS,  CA,  US.
Initial Importer;  
INSEAT SOLUTIONS, LLC
SANTA FE SPRINGS,  CA ,  US.
IN-SIGHT
RUMFORD,  RI,  US.
Manufacturer;  
IN-SIGHT
RUMFORD,  RI ,  US.
INSIGHT INSTRUMENTS, INC.
SANFORD,  FL,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
INSIGHT INSTRUMENTS, INC.
SANFORD,  FL ,  US.
INSIGHT MEDICAL PRODUCTS, LLC
BOYNTON BEACH,  FL,  US.
Manufacturer;  
INSIGHT MEDICAL PRODUCTS, LLC
BOYNTON BEACH,  FL ,  US.
INSIGHT MEDICAL SYSTEMS LTD
TOLEDO,  OH,  US.
Manufacturer;  
INSIGHT MEDICAL SYSTEMS LTD
TOLEDO,  OH ,  US.
INSIGHT OPTICAL MFG. CO. OF FLORIDA, INC.
HIALEAH,  FL,  US.
Initial Importer;  
INSIGHT OPTICAL MFG. CO. OF FLORIDA, INC.
HIALEAH,  FL ,  US.
INSIGHT WORLD GROUP
NAPERVILLE,  IL,  US.
Initial Importer;  
INSIGHT WORLD GROUP
NAPERVILLE,  IL ,  US.
INSIGHT, INC.
GOLD HILL,  OR,  US.
Initial Importer;   Manufacturer;  
INSIGHT, INC.
GOLD HILL,  OR ,  US.
INSIGHTEC-TXSONICS, INC.
DALLAS,  TX,  US.
Initial Importer;  
INSIGHTEC-TXSONICS, LTD.
TIRAT CARMEL,  IS.
INSIGHTEC-TXSONICS, LTD.
TIRAT CARMEL,  IS.
Manufacturer;  
INSIGHTEC-TXSONICS, LTD.
TIRAT CARMEL,  IS.
INSIGHTRA MEDICAL, INC.
IRVINE,  CA,  US.
Initial Importer;   Specification Developer;  
INSIGHTRA MEDICAL, INC.
IRVINE,  CA ,  US.
INSITE ONE, INC.
WALLINGFORD,  CT,  US.
Manufacturer;  
INSITE ONE, INC.
WALLINGFORD,  CT ,  US.
INSITU SYSTEMS
CHRISTCHURCH,  NZ.
Foreign Exporter;   Manufacturer;  
INSITU SYSTEMS
CHRISTCHURCH,  NZ.
INSITU TECHNOLOGIES, INC.
INVER GROVE HEIGHTS,  MN,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
INSITU TECHNOLOGIES, INC.
INVER GROVE HEIGHTS,  MN ,  US.
INSOLE INNOVATIONS
AKRON,  OH,  US.
Initial Importer;  
INSOLE INNOVATIONS
AKRON,  OH ,  US.
INSOUND MEDICAL INC.
NEWARK,  CA,  US.
Manufacturer;  
INSOUND MEDICAL INC.
NEWARK,  CA ,  US.
INSPECS USA
CLEARWATER,  FL,  US.
Initial Importer;  
INSPECS USA
CLEARWATER,  FL ,  US.
INSPEKTOR DENTAL CARE BV
AMSTERDAM,  NL.
Manufacturer;  
INSPEKTOR DENTAL CARE BV
AMSTERDAM,  NL.
INSPIRATION MANUFACTURING & TRADING CO.
GUANGDONG PROVINCE,  TW.
Manufacturer;  
INSPIRATION MANUFACTURING & TRADING CO.
TAIPEI,  TW.
INSPIRSTAR, INC.
CHANDLER,  AZ,  US.
Specification Developer;  
INSPIRSTAR, INC.
CHANDLER,  AZ ,  US.
INSTANT SYSTEMS, INC.
NORFOLK,  VA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
INSTANT SYSTEMS, INC.
NORFOLK,  VA ,  US.
INSTANTRON
RIVERSIDE,  RI,  US.
Manufacturer;  
INSTANTRON
RIVERSIDE,  RI ,  US.
INSTEAD, INC.
LA JOLLA,  CA,  US.
Manufacturer;   Specification Developer;  
INSTEAD, INC.
LA JOLLA,  CA ,  US.
IN-STEP MOBILITY PRODUCTS CORPORATION
SKOKIE,  IL,  US.
Manufacturer;  
IN-STEP MOBILITY PRODUCTS CORPORATION
SKOKIE,  IL ,  US.
INSTITUT STRAUMANN AG
WALDENBURG,  SZ.
Manufacturer;  
INSTITUT STRAUMANN AG
BASEL,  SZ.
INSTITUT STRAUMANN SA
VILLERET,  SZ.
Manufacturer;  
INSTITUT STRAUMANN AG
BASEL,  SZ.
INSTITUT VIRION AG
RUSCHLIKON,  SZ.
Manufacturer;  
INSTITUT VIRION AG
RUSCHLIKON,  SZ.
INSTITUTE FOR APPLICATION OF ATOMIC ENERGY,CAAS
HAIDIAN DIST., BEIJING,  CH.
Contract Sterilizer;  
INSTITUTE FOR APPLICATION OF ATOMIC ENERGY,CAAS
HAIDIAN DIST., BEIJING,  CH.
INSTITUTE OF RADIATION TECHNIQUE-SOOCHOW UNIVERSIT
JIANGSU,  CH.
Contract Sterilizer;  
INSTITUTE OF RADIATION TECHNIQUE-SOOCHOW UNIVERSIT
JIANGSU,  CH.
INSTITUTE OF TECHNICAL SCIENCES OF THE ACADEMY
BELGRADE, YUGOSLAVIA,  SR.
Unregistered Foreign Lister;  
INSTITUTE OF TECHNICAL SCIENCES OF THE ACADEMY
BELGRADE, YUGOSLAVIA,  SR.
INSTITUTIONAL CONTRACT SALES, INC.
BEDFORD,  NH,  US.
Initial Importer;  
INSTITUTIONAL CONTRACT SALES, INC.
BEDFORD,  NH ,  US.
INSTITUTIONAL SALES CORP.
ST. PETERSBURG,  FL,  US.
Initial Importer;  
INSTITUTIONAL SALES CORP.
ST. PETERSBURG,  FL ,  US.
INSTRAMED SURGICAL ASSOC., INC.
ROANOKE,  TX,  US.
Initial Importer;  
INSTRAMED SURGICAL ASSOC., INC.
ROANOKE,  TX ,  US.
INSTRATEK, INC.
THE WOODLANDS,  TX,  US.
Manufacturer;  
INSTRATEK, INC.
THE WOODLANDS,  TX ,  US.
INSTROMEDIX
SAN DIEGO,  CA,  US.
Manufacturer;  
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
REHOVOT,  IS.
INSTRUMED (PVT) LTD.
SIALKOT,  PK.
Manufacturer;  
INSTRUMED (PVT) LTD.
SIALKOT,  PK.

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Last Modified: 29 April 2006
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