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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
IPCH MANAGEMENT, INC.
SUGAR LAND,  TX,  US.
Specification Developer;  
IPCH MANAGEMENT, INC.
SUGAR LAND,  TX ,  US.
IPGDX
HARRISVILLE,  MI,  US.
Specification Developer;  
THE NUTRITION SOLUTIONS, CORPORATION
HARRISVILLE,  MI ,  US.
IPT TECHNOLOGIES, INC.
OLD SAYBROOK,  CT,  US.
Initial Importer;  
IPT TECHNOLOGIES, INC.
OLD SAYBROOK,  CT ,  US.
IQ ACCESSOREIS, INC.
EDEN PRAIRIE,  MN,  US.
Initial Importer;  
IQ ACCESSOREIS, INC.
EDEN PRAIRIE,  MN ,  US.
IQ CORPORATION B.V.
GRONINGEN,  NL.
Manufacturer;  
IQ CORPORATION B.V.
GRONINGEN,  NL.
IQ TEQ
CAPE TOWN,  SF.
Manufacturer;  
IQ TEQ
CAPE TOWN,  SF.
IQAIR NORTH AMERICA, INC.
SANTA FE SPRINGS,  CA,  US.
Initial Importer;  
ICLEEN E.V.U.
SCHAAN,  LS.
IQUIRE, LLC
BREWSTER,  NY,  US.
Manufacturer;  
IQUIRE, LLC
BREWSTER,  NY ,  US.
IRA LERNER STUDIO, LLC
NEW YORK,  NY,  US.
Initial Importer;  
IRA LERNER STUDIO, LLC
NEW YORK,  NY ,  US.
IRADIMED CORPORATION
WINTER PARK,  FL,  US.
Manufacturer;   Specification Developer;  
IRADIMED CORPORATION
WINTER PARK,  FL ,  US.
IREA CORPORATION
NAMYANGJU CITY, KYOUNGGI-DO,  KS.
Manufacturer;  
IREA CORPORATION
NAMYANGJU CITY, KYOUNGGI-DO,  KS.
IREMA IRELAND
CO. LIMERICK,  EI.
Manufacturer;  
IREMA IRELAND
CO. LIMERICK,  EI.
IRENDA CORP.
LOS ANGELES,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IRENDA CORP.
LOS ANGELES,  CA ,  US.
IRENE CORP.
TAINAN,  TW.
Manufacturer;  
IRENE CORP.
TAINAN,  TW.
I-REP, INC.
LAKE ELSINORE,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
I-REP, INC.
LAKE ELSINORE,  CA ,  US.
IRIDE SRL
S. VITO DI VALDOBBIADENE (TV),  IT.
Manufacturer;  
IRIDE SRL
S. VITO DI VALDOBBIADENE (TV),  IT.
IRIDEX CORP.
MOUNTAIN VIEW,  CA,  US.
Initial Importer;   Manufacturer;  
IRIDEX CORP.
MOUNTAIN VIEW,  CA ,  US.
IRIS DEUTSCHLAND GMBH
MARBURG, HESSEN,  GM.
Manufacturer;  
IRIS DIAGNOSTICS
CHATSWORTH,  CA ,  US.
IRIS GRAPHICS, INC.
BEDFORD,  MA,  US.
Contract Manufacturer;  
SCITEX CORPORATION LTD.
HERZLIA,  IS.
IRIS INTERNATIONAL, INC.
CHATSWORTH,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IRIS DIAGNOSTICS
CHATSWORTH,  CA ,  US.
IRIS SAMPLE PROCESSING
WESTWOOD,  MA,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
IRIS DIAGNOSTICS
CHATSWORTH,  CA ,  US.
IRISH EYES, LTD.
HACKETTSTOWN,  NJ,  US.
Initial Importer;  
IRISH EYES, LTD.
HACKETTSTOWN,  NJ ,  US.
IRIS-INNOVATION RECHERCHE EN INGENIERIE DE SYSTEME
MONTCEAU,  FR.
Unregistered Foreign Lister;  
IRIS-INNOVATION RECHERCHE EN INGENIERIE DE SYSTEME
MONTCEAU,  FR.
IRITECH, INC.
VIENNA,  VA,  US.
Manufacturer;  
IRITECH, INC.
VIENNA,  VA ,  US.
IROM IMAGING, INC.
ENGLEWOOD,  CO,  US.
Manufacturer;  
IROM IMAGING, INC.
ENGLEWOOD,  CO ,  US.
IRON HORSE PRODUCTIONS, INC.
PORT HURON,  MI,  US.
Manufacturer;  
IRON HORSE PRODUCTIONS, INC.
PORT HURON,  MI ,  US.
IRONWOOD INDUSTRIES, INC.
LIBERTYVILLE,  IL,  US.
Contract Manufacturer;  
IRONWOOD INDUSTRIES, INC.
LIBERTYVILLE,  IL ,  US.
IRONWOOD PLASTICS, INC.
IRONWOOD,  MI,  US.
Manufacturer;  
IRONWOOD PLASTICS, INC.
IRONWOOD,  MI ,  US.
IRUFA INDUSTRIAL GROUP CO., LTD.
TAINAN CITY,  TW.
Manufacturer;  
IRUFA INDUSTRIAL GROUP CO., LTD.
TAINAN CITY,  TW.
IRVINE BIOMEDICAL, INC.
IRVINE,  CA,  US.
Manufacturer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
IRVINE ELECTRONICS, INC.
IRVINE,  CA,  US.
Contract Manufacturer;  
IRVINE ELECTRONICS, INC.
IRVINE,  CA ,  US.
IRVINE SCIENTIFIC SALES CO., INC.
SANTA ANA,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IRVINE SCIENTIFIC SALES CO., INC.
SANTA ANA,  CA ,  US.
IRVING GROSSMAN
SYOSSET,  NY,  US.
Initial Importer;   Manufacturer;  
IRVING GROSSMAN
SYOSSET,  NY ,  US.
IRVING KANNETT & ASSOC., INC.
MORTON GROVE,  IL,  US.
Initial Importer;  
IRVING KANNETT & ASSOC., INC.
MORTON GROVE,  IL ,  US.
IS2 MEDICAL SYSTEMS, INC.
OTTAWA, ONTARIO,  CA.
Manufacturer;  
IS2 MEDICAL SYSTEMS, INC.
OTTAWA, ONTARIO,  CA.
ISAAC INDUSTRIAL CO., LTD.
ASAN-SI, CHOONGNAM,  KS.
Manufacturer;  
ISAAC INDUSTRIAL CO., LTD.
ASAN-SI, CHOONGNAM,  KS.
ISAN DIST.
ELIZABETH,  NJ,  US.
Initial Importer;  
ISAN DIST.
ELIZABETH,  NJ ,  US.
ISCAR BLADES LTD.
NAHARIYA,  IS.
Contract Manufacturer;   Manufacturer;  
ISCAR BLADES LTD.
NAHARIYA,  IS.
ISCHEMIA TECHNOLOGIES, INC.
ARVADA,  CO,  US.
Manufacturer;  
ISCHEMIA TECHNOLOGIES, INC.
ARVADA,  CO ,  US.
ISCIENCE SURGICAL
MENLO PARK,  CA,  US.
Manufacturer;  
ISCIENCE SURGICAL
MENLO PARK,  CA ,  US.

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Last Modified: 29 April 2006
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