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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
I.P.I.E., LTD.
MIDDLETOWN,  NY,  US.
Initial Importer;  
IPIE LTD., ANYS CORP.
MIDDLETOWN,  NY ,  US.
I.P.S. INTERNATIONAL PRODUCTS & SERVICES
SAN DONATO MIL.SE,  IT.
Manufacturer;  
I.P.S. INTERNATIONAL PRODUCTS & SERVICES
SAN DONATO MIL.SE,  IT.
I.S. IMPORT EXPORT CORP.
MIAMI,  FL,  US.
Initial Importer;  
I.S. IMPORT EXPORT CORP.
MIAMI,  FL ,  US.
I.S. TECHNOLOGY
POTOMAC,  MD,  US.
Initial Importer;  
I.S. TECHNOLOGY
POTOMAC,  MD ,  US.
I.T.I., INC.
MISSOULA,  MT,  US.
Contract Manufacturer;  
I.T.I., INC.
MISSOULA,  MT ,  US.
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
LASSNITZHOEHE,  AU.
Manufacturer;  
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
LASSNITZHOEHE,  AU.
I.V. HOUSE
HAZELWOOD,  MO,  US.
Specification Developer;  
I.V. HOUSE, INC.
HAZELWOOD,  MO ,  US.
I.V. LEAGUE MEDICAL
OXNARD,  CA,  US.
Manufacturer;  
I.V. LEAGUE MEDICAL
OXNARD,  CA ,  US.
I.Z.I. CORP.
BALTIMORE,  MD,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
I.Z.I. CORP.
BALTIMORE,  MD ,  US.
I4T
VITTORIO VENETO,  IT.
Foreign Exporter;  
I4T
VITTORIO VENETO,  IT.
IAC INTL.
MINNEAPOLIS,  MN,  US.
Initial Importer;  
IAC INTL.
MINNEAPOLIS,  MN ,  US.
IALIN OPTICAL MFG (CHINA) CO., LTD.
GUANG-DONG PROVINCE,  CH.
Manufacturer;  
YALIN TRADING CO., LTD.
TAIPEI,  TW.
IALIN OPTICAL MFG., (H.K.) CO. LTD.
YAUMATI, KLN.,  HK.
Manufacturer;  
IALIN OPTICAL MFG., (H.K.) CO. LTD.
YAUMATI, KLN.,  HK.
IBA S&I LTD.
PLUAK DAENG, RAYONG,  TH.
Contract Sterilizer;  
IBA SA
LOUVAIN-LA-NEUVE,  BE.
IBA/GRIFFITH
WILLOWBROOK,  IL,  US.
Contract Sterilizer;  
IBA-GRIFFITH MICRO SCIENCE, INC.
CHICAGO,  IL ,  US.
I-BEAM WALKING MACHINE
FARMINGTON HILLS,  MI,  US.
Manufacturer;  
I-BEAM WALKING MACHINE
FARMINGTON HILLS,  MI ,  US.
IBEX DIRECT, INC.
HUNTINGTON,  NY,  US.
Initial Importer;  
IBEX DIRECT, INC.
HUNTINGTON,  NY ,  US.
IBI SYNERGY, INC.
FREMONT,  CA,  US.
Initial Importer;  
IBI SYNERGY, INC.
FREMONT,  CA ,  US.
IBICI CALZA, INDUSTRIA BUSTESE CALZA S.P.A.
LARGO TICINO, 3,  IT.
Unregistered Foreign Lister;  
IBICI CALZA, INDUSTRIA BUSTESE CALZA S.P.A.
LARGO TICINO, 3,  IT.
IBIS TEK LLC
BUTLER,  PA,  US.
Manufacturer;  
IBIS TEK LLC
BUTLER,  PA ,  US.
IBL GMBH
HAMBURG,  GM.
Manufacturer;  
IBL GMBH
HAMBURG,  GM.
IBL MEDIKAL URUNLER SANAYI VE TICARET LTD. STI
YENIMAHALLE/ANKARA,  TU.
Manufacturer;  
IBL MEDIKAL URUNLER SANAYI VE TICARET LTD. STI
YENIMAHALLE/ANKARA,  TU.
IBM INTEGRATED TOOL TECHNOLOGY CENTER
ROCHESTER,  MN,  US.
Contract Manufacturer;  
IBM INTEGRATED TOOL TECHNOLOGY CENTER
NORTH ROCHESTER,  MN ,  US.
IBN SINA MEDICAL FACTORY IN BAHRAIN
MANAMA,  BA.
Unregistered Foreign Lister;  
IBN SINA MEDICAL FACTORY IN BAHRAIN
MANAMA,  BA.
I-BOUTIQUE
BURBANK,  CA,  US.
Initial Importer;  
MARCA NOMA GROUP, INC.
BURBANK,  CA ,  US.
IBOX CORPORATION
CHIAYI,  TW.
Foreign Exporter;   Manufacturer;  
IBOX CORPORATION
CHIAYI,  TW.
IBP INSTRUMENTS GMBH
HANNOVER,  GM.
Manufacturer;  
IBP INSTRUMENTS GMBH
HANNOVER,  GM.
IBP MEDICAL, INC.
PHOENIX,  AZ,  US.
Initial Importer;  
IBP MEDICAL, INC.
PHOENIX,  AZ ,  US.
IC OPTICS S.P.A.
GAZZADA=SCHIANNO, VARESE,  IT.
Manufacturer;  
IC OPTICS S.P.A.
GAZZADA=SCHIANNO, VARESE,  IT.
IC! BERLIN AMERICA, LLC
PHILADELPHIA,  PA,  US.
Initial Importer;  
IC!-BERLIN BRILLEN GMBH
BERLIN,  GM.
IC!-BERLIN BRILLEN GMBH
BERLIN,  GM.
Manufacturer;  
IC!-BERLIN BRILLEN GMBH
BERLIN,  GM.
ICAD INC.
NASHUA,  NH,  US.
Manufacturer;  
ICAD INC.
NASHUA,  NH ,  US.
ICAD, INC.
BEAVERCREEK,  OH,  US.
Specification Developer;  
ICAD INC.
NASHUA,  NH ,  US.
ICAN MEDICAL, INC.
TORONTO, ONTARIO,  CA.
Foreign Exporter;  
ICAN MEDICAL, INC.
TORONTO, ONTARIO,  CA.
ICARDIA HEALTHCARE CORPORATION
LAKE FOREST,  IL,  US.
Initial Importer;   Repackager/Relabeller;  
ICARDIA HEALTHCARE CORPORATION
LAKE FOREST,  IL ,  US.
ICARE (HONG KONG) CO. LTD.
KOWLOON,  HK.
Contract Manufacturer;  
ICARE (HONG KONG) CO. LTD.
KOWLOON,  HK.
ICARE MEDICAL CO., LTD.
CENTER, TIANJIN,  CH.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
ICARE MEDICAL CO., LTD.
CENTER, TIANJIN,  CH.
ICCA, A DIVISION OF INTERNET SERVICES CORPORATION
FORT MILL,  SC,  US.
Contract Manufacturer;   Repackager/Relabeller;  
ICCA, A DIVISION OF INTERNET SERVICES CORPORATION
FORT MILL,  SC ,  US.
ICEL INDUSTRIA E COMERCIO ELECTRONICA LTDA
SAO PAULO,  BR.
Unregistered Foreign Lister;  
ICEL INDUSTRIA E COMERCIO ELECTRONICA LTDA
SAO PAULO,  BR.
ICHAUWAY MILLS, INC.
DALLAS,  TX,  US.
Specification Developer;  
ICHAUWAY MILLS, INC.
DALLAS,  TX ,  US.

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Last Modified: 29 April 2006
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