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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
INTERNATIONAL TRADE ROUTES OF NEW YORK, INC.
NIVERVILLE,  NY,  US.
Initial Importer;  
INTERNATIONAL TRADE ROUTES OF NEW YORK, INC.
NIVERVILLE,  NY ,  US.
INTERNAZIONALE MEDICO SCIENTIFICA (IMS)
BOLOGNA,  IT.
Manufacturer;  
INTERNAZIONALE MEDICO SCIENTIFICA (IMS)
BOLOGNA,  IT.
INTERNET PLAZA INC.
MIAMI,  FL,  US.
Initial Importer;  
INTERNET PLAZA INC.
MIAMI,  FL ,  US.
INTEROJO INC.
PYONGTAEK-CITY, KYONGGI-DO,  KS.
Contract Manufacturer;  
INTEROJO INC.
PYONGTAEK-CITY, KYONGGI-DO,  KS.
INTER-PAL GMBH
ERLANGEN,  GM.
Manufacturer;  
INTER-PAL GMBH
ERLANGEN,  GM.
INTERPHASE IMPLANTS, INC.
LIVONIA,  MI,  US.
Specification Developer;   Repackager/Relabeller;  
INTERPHASE IMPLANTS, INC.
LIVONIA,  MI ,  US.
INTERPLAST S.A.
MEDELLIN, ANTIOQUIA,  CO.
Manufacturer;  
INTERPLAST S.A.
MEDELLIN, ANTIOQUIA,  CO.
INTERPLEX MEDICAL, LLC
MILFORD,  OH,  US.
Contract Manufacturer;   Specification Developer;  
INTERPLEX MEDICAL, LLC
MILFORD,  OH ,  US.
INTERPORE CROSS INTL.
IRVINE,  CA,  US.
Contract Manufacturer;   Manufacturer;  
INTERPORE CROSS INTL.
IRVINE,  CA ,  US.
INTERPREMIER GROUP, LLC
COOPER CITY,  FL,  US.
Initial Importer;  
INTERPREMIER GROUP, LLC
COOPER CITY,  FL ,  US.
INTERSCAN CORP.
CHATSWORTH,  CA,  US.
Manufacturer;  
INTERSCAN CORP.
CHATSWORTH,  CA ,  US.
INTERSCIENTIFIC CORPORATION
HOLLYWOOD,  FL,  US.
Initial Importer;  
INTERSCIENTIFIC CORPORATION
HOLLYWOOD,  FL ,  US.
INTERSECT SYSTEMS, INC.
LONGVIEW,  WA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
INTERSECT SYSTEMS, INC.
LONGVIEW,  WA ,  US.
INTERSOL SPA
MONVALLE, VARESE,  IT.
Manufacturer;  
INTERSOL SPA
MONVALLE, VARESE,  IT.
INTERSON CORP.
PLEASANTON,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
INTERSON CORP.
PLEASANTON,  CA ,  US.
INTERSPORT FASHIONS WEST, INC.
TUSTIN,  CA,  US.
Initial Importer;  
INTERSPORT FASHIONS WEST, INC.
TUSTIN,  CA ,  US.
INTERSTATE HEARING AID SERVICE
WILKES BARRE,  PA,  US.
Manufacturer;  
ACCUTONE, INC.
WILKES-BARRE,  PA ,  US.
INTERSTOL TRADING CO.
SEATTLE,  WA,  US.
Initial Importer;  
INTERSTOL TRADING CO.
SEATTLE,  WA ,  US.
INTERSURGICAL LIMITED-GUERNSEY
ST. PETER PORT, GUERNSEY,  UK.
Contract Manufacturer;  
INTERSURGICAL LTD.
WOKINGHAM, BERKSHIRE,  UK.
INTERSURGICAL LTD.
WOKINGHAM, BERKSHIRE,  UK.
Contract Manufacturer;  
INTERSURGICAL LTD.
WOKINGHAM, BERKSHIRE,  UK.
INTERSURGICAL UAB
PABRADE,  LH.
Contract Manufacturer;  
INTERSURGICAL UAB
PABRADE,  LH.
INTERSURGICAL, INC.
LIVERPOOL,  NY,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
INTERSURGICAL, INC.
LIVERPOOL,  NY ,  US.
INTERTON HOERGERAETE GMBH
BERGISCH GLADBACH,  GM.
Manufacturer;  
INTERTON HOERGERAETE GMBH
BERGISCH GLADBACH,  GM.
INTERTRADE 1
PROVO,  UT,  US.
Initial Importer;  
INTERTRADE 1
PROVO,  UT ,  US.
INTERTRADE CORP.
CHEVERLY,  MD,  US.
Initial Importer;  
INTERTRADE CORP.
CHEVERLY,  MD ,  US.
INTERVASCULAR, SAS
LACIOTAT,  FR.
Foreign Exporter;   Manufacturer;  
DATASCOPE, CORP.
MONTVALE,  NJ ,  US.
INTERVENTIONAL HEMOSTASIS PRODUCTS, INC.
BEAVERTON,  OR,  US.
Manufacturer;   Specification Developer;  
GSEM, INC.
TUALATIN,  OR ,  US.
INTERVENTIONAL MEDICAL DESIGN, INCORPORATED
SAN JOSE,  CA,  US.
Initial Importer;  
INTERVENTIONAL MEDICAL DESIGN, INCORPORATED
SAN JOSE,  CA ,  US.
INTERVENTIONAL PRODUCTS DIVISION
MAHWAH,  NJ,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
DATASCOPE CORP.
MONTVALE,  NJ ,  US.
INTERVISION S & S CORP.
ROSWELL,  GA,  US.
Initial Importer;  
INTERVISION S & S CORP.
ROSWELL,  GA ,  US.
INTI CHANDRA TRADING CO.
FRESNO,  CA,  US.
Initial Importer;  
EVERGREEN TRADING CO.
FRESNO,  CA ,  US.
INTIATIVE TECHNOLGY INC.
TAO YUAN,  TW.
Manufacturer;  
INTIATIVE TECHNOLGY INC.
TAO YUAN,  TW.
INT'L ALLY, INC.
WOODLAND HILLS,  CA,  US.
Initial Importer;   Manufacturer;  
INT'L ALLY, INC.
WOODLAND HILLS,  CA ,  US.
INT'L PLASTICS, INC.
GREENVILLE,  SC,  US.
Repackager/Relabeller;  
INT'L PLASTICS, INC.
GREENVILLE,  SC ,  US.
INTL. ACQUISITIONS, INC.
NEW HOPE,  PA,  US.
Initial Importer;  
INTL. ACQUISITIONS, INC.
NEW HOPE,  PA ,  US.
INTL. AQUATIC TRADES, INC.
SANTA CRUZ,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
INTL. AQUATIC TRADES, INC.
SANTA CRUZ,  CA ,  US.
INTL. CRUISE DUTY FREE, INC.
MIAMI,  FL,  US.
Initial Importer;  
INTL. CRUISE DUTY FREE, INC.
MIAMI,  FL ,  US.
INTL. DENTAL DESIGN SPECIALISTS, INC.
SAN DIEGO,  CA,  US.
Specification Developer;  
INTL. DENTAL DESIGN SPECIALISTS, INC.
IMPERIAL BEACH,  CA ,  US.
INTL. DENTAL PRODUCTS
OLCHING,  GM.
Manufacturer;  
INTL. DENTAL PRODUCTS
OLCHING,  GM.
INTL. DEVELOPMENT GROUP, INC.
NEW YORK,  NY,  US.
Initial Importer;  
INTL. DEVELOPMENT GROUP, INC.
NEW YORK,  NY ,  US.

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Last Modified: 29 April 2006
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