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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
INTL. IMMUNO DIAGNOSTICS
FOSTER CITY,  CA,  US.
Initial Importer;  
INTL. IMMUNO DIAGNOSTICS
FOSTER CITY,  CA ,  US.
INTL. MEDICAL DIAGNOSTICS
UNION CITY,  CA,  US.
Contract Manufacturer;  
INTL. MEDICAL DIAGNOSTICS
UNION CITY,  CA ,  US.
INTL. MEDICAL ELECTRONICS LTD.
KANSAS CITY,  KS,  US.
Manufacturer;  
INTL. MEDICAL ELECTRONICS LTD.
KANSAS CITY,  KS ,  US.
INTL. MEDICAL ELECTRONICS LTD.
KANSAS CITY,  KS,  US.
Manufacturer;  
INTL. MEDICAL ELECTRONICS LTD.
KANSAS CITY,  KS ,  US.
INTL. MEDICAL INDUSTRIES
POMPANO BEACH,  FL,  US.
Manufacturer;  
INTL. MEDICAL INDUSTRIES
POMPANO BEACH,  FL ,  US.
INTL. MEDICAL MARKETING, INC.
CHEPACHET,  RI,  US.

INTL. MEDICAL MARKETING, INC.
CHEPACHET,  RI ,  US.
INTL. MEDICAL, INC.
BURNSVILLE,  MN,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
INTL. MEDICAL, INC.
BURNSVILLE,  MN ,  US.
INTL. MEDICAL-DENTAL PRODUCTS USA, INC.
HUNTSVILLE,  UT,  US.
Initial Importer;  
INTL. MEDICAL-DENTAL PRODUCTS USA, INC.
HUNTSVILLE,  UT ,  US.
INTL. MEDICATION SYSTEMS, LTD.
SOUTH EL MONTE,  CA,  US.
Manufacturer;  
AMPHASTAR PHARMACEUTICAL, INC.
RANCHO CUCAMONGA,  CA ,  US.
INTL. MEDSURG CONNECTION, INC.
SCHAUMBURG,  IL,  US.
Initial Importer;   Specification Developer;  
INTL. MEDSURG CONNECTION, INC.
SCHAUMBURG,  IL ,  US.
INTL. NEEDLE, INC.
CLOVER,  SC,  US.
Initial Importer;  
INTL. NEEDLE, INC.
ROCK HILL,  SC ,  US.
INTL. OPTICAL MART, INC.
MIAMI,  FL,  US.
Initial Importer;  
INTL. OPTICAL MART, INC.
MIAMI,  FL ,  US.
INTL. ORTHOPAEDIC INSTRUMENT-DISTRIBUTOR
MIAMI,  FL,  US.
Initial Importer;  
INTL. ORTHOPAEDIC INSTRUMENT-DISTRIBUTOR
MIAMI,  FL ,  US.
INTL. RUBBER DIST., INC.
MEDINA,  OH,  US.
Initial Importer;  
INTL. RUBBER DIST., INC.
MEDINA,  OH ,  US.
INTL. SALES/MARKETING GROUP
NEW YORK,  NY,  US.
Initial Importer;  
INTL. SALES/MARKETING GROUP
NEW YORK,  NY ,  US.
INTL. SPECIALTIES, INC.
LAS VEGAS,  NV,  US.
Initial Importer;  
INTL. SPECIALTIES, INC.
LAS VEGAS,  NV ,  US.
INTOXIMETERS, INC.
ST. LOUIS,  MO,  US.
Specification Developer;  
INTOXIMETERS, INC.
ST. LOUIS,  MO ,  US.
INTRA LASE CORP.
IRVINE,  CA,  US.
Manufacturer;  
INTRA LASE CORP.
IRVINE,  CA ,  US.
INTRA PUMP INFUSION SYSTEMS
CHEEKTOWAGA,  NY,  US.
Initial Importer;  
INTERNATIONAL INFUSION, LLC.
GENEVA,  IL ,  US.
INTRA VANTAGE, INC.
PLYMOUTH,  MN,  US.
Manufacturer;   Specification Developer;  
INTRA VANTAGE, INC.
PLYMOUTH,  MN ,  US.
INTRACO AG
MORBIO INFERIORE,  SZ.
Manufacturer;   Repackager/Relabeller;  
INTRACO AG
MORBIO INFERIORE,  SZ.
INTRA-LOCK INTERNATIONAL
BOCA RATON,  FL,  US.
Contract Manufacturer;   Specification Developer;   Repackager/Relabeller;  
INTRA-LOCK INTERNATIONAL
BOCA RATON,  FL ,  US.
INTRALUMINAL THERAPEUTICS, INC.
CARLSBAD,  CA,  US.
Manufacturer;  
INTRALUMINAL THERAPEUTICS, INC.
CARLSBAD,  CA ,  US.
INTRAMEDICA CORP.
MIAMI,  FL,  US.
Initial Importer;  
INTRAMEDICA CORP.
MIAMI,  FL ,  US.
INTRAMEDICAL IMAGING LLC.
LOS ANGELES,  CA,  US.
Specification Developer;  
INTRAMEDICAL IMAGING LLC.
LOS ANGELES,  CA ,  US.
INTRAOCULAR OPTICAL INTERNATIONAL
SAN DIMAS,  CA,  US.
Specification Developer;  
INTRAOCULAR OPTICAL INTERNATIONAL
SAN DIMAS,  CA ,  US.
INTRAOP MEDICAL, INC.
SANTA CLARA,  CA,  US.
Manufacturer;   Specification Developer;  
INTRAOP MEDICAL, INC.
SANTA CLARA,  CA ,  US.
INTRASAFE MEDICAL, LLC
FRISCO,  TX,  US.
Specification Developer;  
INTRASAFE MEDICAL, LLC
FRISCO,  TX ,  US.
INTRATEK CORP.
LEESBURG,  FL,  US.

INTRATEK CORP.
LEESBURG,  FL ,  US.
INTRAVASCULAR INCORPORATED
WAUKEGAN,  IL,  US.
Manufacturer;   Specification Developer;  
INTRAVASCULAR INCORPORATED
WAUKEGAN,  IL ,  US.
INTREX MACHINING
LOUISVILLE,  CO,  US.
Contract Manufacturer;  
INTREX MACHINING
LOUISVILLE,  CO ,  US.
INTRICON CORPORATION
ARDEN HILLS,  MN,  US.
Contract Manufacturer;  
INTRICON CORPORATION
ARDEN HILLS,  MN ,  US.
INTRIGUE MARKETING, INC.
JANESVILLE,  WI,  US.
Initial Importer;  
INTRIGUE MARKETING, INC.
JANESVILLE,  WI ,  US.
INTROMARK, INC.
PITTSBURGH,  PA,  US.
Initial Importer;  
TECHOSYSTEMS SERVICE CORP.
PITTSBURGH,  PA ,  US.
INTRONIX TECHNOLOGIES CORP.
BOLTON,  CA.
Contract Manufacturer;   Manufacturer;  
INTRONIX TECHNOLOGIES CORP.
BOLTON,  CA.
INTUBATION PLUS, INC.
CORRY,  PA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
INTUBATION PLUS, INC.
CORRY,  PA ,  US.
INTUITIVE IMAGING INFORMATICS, LLC
BELL CANYON,  CA,  US.
Manufacturer;   Specification Developer;  
INTUITIVE IMAGING INFORMATICS, LLC
BELL CANYON,  CA ,  US.
INTUITIVE SURGICAL, INC.
SUNNYVALE,  CA,  US.
Manufacturer;   Specification Developer;  
INTUITIVE SURGICAL, INC.
SUNNYVALE,  CA ,  US.
INTVISION CO. LTD.
DONG, GUMJUNG-GU BUSAN,  KS.
Manufacturer;  
INTVISION CO. LTD.
DONG, GUMJUNG-GU BUSAN,  KS.
INVACARE AUSTRALIA PTY LTD
CHELTENHAM, VICTORIA,  AS.
Manufacturer;  
INVACARE AUSTRALIA
CHELTENHAM, VICTORIA,  AS.

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Last Modified: 29 April 2006
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