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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
IL CEPPO SRL
FIRENZE,  IT.
Manufacturer;  
IL CEPPO SRL
FIRENZE,  IT.
IL KWANG OPTICAL CORP.
TAEGU,  KS.
Manufacturer;  
IL KWANG OPTICAL CORP.
TAEGU,  KS.
IL SEUN OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
IL SEUN OPTICAL CO.
DAEGU,  KS.
IL SIN OPTICAL CO., LTD.
DAEGU,  KS.
Manufacturer;  
IL SIN OPTICAL CO., LTD.
DAEGU,  KS.
IL SUK OPTICAL CO., LTD.
DAEGU,  KS.
Manufacturer;  
IL SUK OPTICAL CO., LTD.
DAEGU,  KS.
ILC NEW YORK INC.
FOREST HILLS,  NY,  US.
Initial Importer;  
ILC NEW YORK INC.
FOREST HILLS,  NY ,  US.
ILG MEDIZINTECHNIK GMBH
DURCHHAUSEN,  GM.
Manufacturer;  
ILG MEDIZINTECHNIK GMBH
DURCHHAUSEN,  GM.
ILGIN BINICS CO., LTD.
ANYANG CITY, KYUNG KI-DO,  KS.
Manufacturer;  
ILGIN BINICS CO., LTD.
ANYANG CITY, KYUNG KI-DO,  KS.
ILL YANG MEDICAL & SO MANG CO. LTD.
KANG WON DO,  KS.
Manufacturer;  
ILL YANG MEDICAL & SO MANG CO. LTD.
KANG WON DO,  KS.
ILL YANG MEDICAL (DBA SO MANG) CO. LTD.
GANG WON DO,  KS.
Unregistered Foreign Lister;  
ILL YANG MEDICAL (DBA SO MANG) CO. LTD.
GANG WON DO,  KS.
ILLES CSOK ES TSA. BT.
BUDAPEST,  HU.
Manufacturer;  
ILLES CSOK ES TSA. BT.
BUDAPEST,  HU.
ILLINI
VERNON HILLS,  IL,  US.
Initial Importer;  
ILLINI
VERNON HILLS,  IL ,  US.
ILLINOIS INDUSTRIAL TOOL, INC.
BRIDGEVIEW,  IL,  US.
Initial Importer;  
ILLINOIS INDUSTRIAL TOOL, INC.
BRIDGEVIEW,  IL ,  US.
ILLUSION INDUSTRIES, LLC
WESTLAKE VILLAGE,  CA,  US.
Initial Importer;  
ILLUSION INDUSTRIES, LLC
WESTLAKE VILLAGE,  CA ,  US.
ILO INDUSTRIA LOMBARDA OTTICA SRL
LODI, LO,  IT.
Manufacturer;  
ILO INDUSTRIA LOMBARDA OTTICA SRL
LODI, LO,  IT.
ILSHIN PHARMCO.
YANGSAN,  KS.
Foreign Exporter;   Manufacturer;  
ILSHIN PHARMCO.
YANGSAN,  KS.
ILSIN A.T.M. CO., LTD.
BUSAN,  KS.
Manufacturer;  
ILSIN A.T.M. CO., LTD.
BUSAN,  KS.
IL-YANG MEDICAL CO., LTD.
DAEJEON, CHOONGNAM,  KS.
Manufacturer;  
IL-YANG MEDICAL CO., LTD.
DAEJEON, CHOONGNAM,  KS.
IMAGE ANALYSIS, INC.
COLUMBIA,  KY,  US.
Manufacturer;  
IMAGE ANALYSIS, INC.
COLUMBIA,  KY ,  US.
IMAGE BUILDERS
ST. CLOUD,  MN,  US.
Initial Importer;  
IMAGE BUILDERS
ST. CLOUD,  MN ,  US.
IMAGE DEVICES GMBH
IDSTEIN,  GM.
Manufacturer;  
CERNER CORP.
KANSAS CITY,  MO ,  US.
IMAGE DIAGNOSTICS, INC.
STERLING,  MA,  US.
Manufacturer;  
IMAGE DIAGNOSTICS, INC.
STERLING,  MA ,  US.
IMAGE ENHANCEMENT SYSTEMS
HAYWARD,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
IMAGE ENHANCEMENT SYSTEMS
HAYWARD,  CA ,  US.
IMAGE MEDICAL CORP.
ALLENTOWN,  PA,  US.
Manufacturer;   Specification Developer;  
IMAGE MEDICAL CORP.
ALLENTOWN,  PA ,  US.
IMAGE OPTICAL
NASHVILLE,  TN,  US.
Initial Importer;  
IMAGE OPTICAL
NASHVILLE,  TN ,  US.
IMAGE OPTICAL DESIGNS
LANCING, WEST SUSSEX,  UK.
Unregistered Foreign Lister;  
IMAGE OPTICAL DESIGNS
LANCING, WEST SUSSEX,  UK.
IMAGE OPTIKS LLC
EAST HAVEN,  CT,  US.
Initial Importer;  
IMAGE OPTIKS LLC
EAST HAVEN,  CT ,  US.
IMAGE PLASTICS, LTD.
KENTLAND,  IN,  US.
Repackager/Relabeller;  
IMAGE PLASTICS, LTD.
KENTLAND,  IN ,  US.
IMAGE PLUS DENTAL TECHNOLOGIES, LLC
DALLAS,  TX,  US.
Contract Manufacturer;  
IMAGE PLUS DENTAL TECHNOLOGIES, LLC
DALLAS,  TX ,  US.
IMAGE STREAM MEDICAL, LLC
LITTLETON,  MA,  US.
Specification Developer;  
IMAGE STREAM MEDICAL, LLC
LITTLETON,  MA ,  US.
IMAGE TECHNOLOGY LABORATORIES, INC.
KINGSTON,  NY,  US.
Manufacturer;  
IMAGE TECHNOLOGY LABORATORIES, INC.
KINGSTON,  NY ,  US.
IMAGE VISIONS, LLC.
ELMSFORD,  NY,  US.
Specification Developer;  
IMAGE VISIONS, LLC.
ELMSFORD,  NY ,  US.
IMAGE WEAR BY WALMAN
MINNEAPOLIS,  MN,  US.
Initial Importer;  
WALMAN OPTICAL
MINNEAPOLIS,  MN ,  US.
IMAGEDERM, INC.
LOS ANGELES,  CA,  US.
Manufacturer;  
IMAGEDERM, INC.
LOS ANGELES,  CA ,  US.
IMAGEFLOW INC.
SUNNYVALE,  CA,  US.
Manufacturer;  
IMAGEFLOW INC.
SUNNYVALE,  CA ,  US.
IMAGEPATH SYSTEMS, INC.
EDWARDSBURG,  MI,  US.
Manufacturer;  
IMAGEPATH SYSTEMS, INC.
EDWARDSBURG,  MI ,  US.
IMAGINE EYES
ORSAY,  FR.
Manufacturer;  
IMAGINE EYES
ORSAY,  FR.
IMAGING 3, INC.
BURBANK,  CA,  US.
Manufacturer;  
IMAGING 3, INC.
BURBANK,  CA ,  US.
IMAGING ACCESSORIES, INC.
SALT LAKE CITY,  UT,  US.
Manufacturer;  
IMAGING ACCESSORIES, INC.
SALT LAKE CITY,  UT ,  US.
IMAGING ARCHIVE INTERNATIONAL, LLC.
NORCROSS,  GA,  US.
Manufacturer;  
IMAGING ARCHIVE INTERNATIONAL, LLC.
NORCROSS,  GA ,  US.

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Last Modified: 29 April 2006
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