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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
HYUNDAI MEDICAL CO., LTD.
SIHUNG-SI, GYUNGGI-DO,  KS.
Manufacturer;  
HYUNDAI MEDICAL CO., LTD.
SIHUNG-SI, GYUNGGI-DO,  KS.
HYUNDAI MOTOR AMERICA
FOUNTAIN VALLEY,  CA,  US.
Initial Importer;  
HYUNDAI CORP.
SEOUL,  KS.
HYUNDAI PHARM. IND. CO., LTD.
BUCHEON-CITY,  KS.
Unregistered Foreign Lister;  
HYUNDAI PHARM. IND. CO., LTD.
BUCHEON-CITY,  KS.
HYUNJIN OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
HYUNJIN OPTICAL CO.
DAEGU,  KS.
HYUP SUNG MEDICAL CO., LTD.
KYUNGGI-DO,  KS.
Manufacturer;  
HYUP SUNG MEDICAL CO., LTD.
KYUNGGI-DO,  KS.
HY-VEE, INC.
WEST DES MOINES,  IA,  US.
Initial Importer;  
HY-VEE, INC.
WEST DES MOINES,  IA ,  US.
I & G OPTICS CO.
DAEJEON, CHUNGNAM,  KS.
Manufacturer;  
I & G OPTICS CO.
DAEJEON, CHUNGNAM,  KS.
I 2 I MODA,INC.
SCOTTSDALE,  AZ,  US.
Initial Importer;  
I 2 I MODA,INC.
SCOTTSDALE,  AZ ,  US.
I B WILLIAMS AG
MAUREN,  SZ.
Unregistered Foreign Lister;  
I B WILLIAMS AG
MAUREN,  SZ.
I C OPTICS, LTD.
WEST CALDWELL,  NJ,  US.
Initial Importer;  
I C OPTICS, LTD.
WEST CALDWELL,  NJ ,  US.
I CARE INTERNATIONAL, INC.
GLENDALE,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
I CARE INTERNATIONAL, INC.
GLENDALE,  CA ,  US.
I CHE CO., LTD.
TAINAN,  TW.
Manufacturer;  
I CHE CO., LTD.
TAINAN,  TW.
I CONNECTION
LARCHMONT,  NY,  US.
Initial Importer;  
I CONNECTION
LARCHMONT,  NY ,  US.
I LINE OPTICAL
LOS ANGELES,  CA,  US.
Initial Importer;  
I LINE OPTICAL
LOS ANGELES,  CA ,  US.
I M, INC.
WHARTON,  NJ,  US.
Initial Importer;  
I M, INC.
WHARTON,  NJ ,  US.
I OPTICS, INC.
OCEANSIDE,  NY,  US.
Initial Importer;  
I OPTICS, INC.
OCEANSIDE,  NY ,  US.
I PLAY
ASHEVILLE,  NC,  US.
Initial Importer;  
FAMILY CLUBHOUSE, INC.
ASHEVILLE,  NC ,  US.
I STEINMETZ & CO INC.
BROOKLYN,  NY,  US.
Initial Importer;  
I STEINMETZ & CO INC.
BROOKLYN,  NY ,  US.
I TECH OPTICS LTD.
WANCHAL,  HK.
Unregistered Foreign Lister;  
I TECH OPTICS LTD.
WANCHAL,  HK.
I W INC.
SAN DIEGO,  CA,  US.
Initial Importer;  
I W INC.
SAN DIEGO,  CA ,  US.
I.A. INDUSTRIES
HAJI PURA, SIALKOT,  PK.
Manufacturer;  
I.A. INDUSTRIES
HAJI PURA, SIALKOT,  PK.
I.B.C. ENGINEERING, LTD.
KIRYAT MATALON, PETAH-TIKVA,  IS.
Unregistered Foreign Lister;  
I.B.C. ENGINEERING, LTD.
KIRYAT MATALON, PETAH-TIKVA,  IS.
I.B.C. INDUSTRIA BUSTESE CALZE S.P.A.
BUSTO ARSIZIO, VARESE,  IT.
Unregistered Foreign Lister;  
I.B.C. INDUSTRIA BUSTESE CALZE S.P.A.
BUSTO ARSIZIO, VARESE,  IT.
I.B.S. (ICE BAG SUPPORT)
PADUCAH,  KY,  US.
Manufacturer;  
I.B.S. (ICE BAG SUPPORT)
PADUCAH,  KY ,  US.
I.C. IMPORTS, INC.
NARBERTH,  PA,  US.
Initial Importer;  
I.C. IMPORTS, INC.
NARBERTH,  PA ,  US.
I.C. MEDICAL, INC.
PHOENIX,  AZ,  US.
Manufacturer;  
I.C. MEDICAL, INC.
PHOENIX,  AZ ,  US.
I.C.B. BRUSH CO., INC.
OSPREY,  FL,  US.
Initial Importer;  
I.C.B. BRUSH CO., INC.
OSPREY,  FL ,  US.
I.C.V. INDUSTRIES
NORTHRIDGE,  CA,  US.
Contract Manufacturer;   Manufacturer;  
I.C.V. INDUSTRIES
NORTHRIDGE,  CA ,  US.
I.D. GROUPE H.D.
FR.
Unregistered Foreign Lister;  
I.D. GROUPE H.D.
FR.
I.E.D., INC.
MUSKEGON,  MI,  US.
Contract Manufacturer;   Manufacturer;  
I.E.D., INC.
MUSKEGON,  MI ,  US.
I.E.M. GMBH
STOLBERG,  GM.
Manufacturer;  
I.E.M. GMBH
STOLBERG,  GM.
I.F. OPTICAL, INC.
CHICAGO,  IL,  US.
Manufacturer;  
I.F. OPTICAL, INC.
CHICAGO,  IL ,  US.
I.M.D. INTERNATIONAL MEDICAL DEVICES S.P.A.
SCANZOROSCIATE (BG),  IT.
Manufacturer;  
I.M.D. INTERNATIONAL MEDICAL DEVICES S.P.A.
SCANZOROSCIATE (BG),  IT.
I.M.P. PLASTIK PRODUCTION GMBH
MANSCHAU,  GM.
Unregistered Foreign Lister;  
I.M.P. PLASTIK PRODUCTION GMBH
MANSCHAU,  GM.
I.M.S
PORTLAND,  OR,  US.
Initial Importer;  
I.M.S
PORTLAND,  OR ,  US.
I.M.T. ACCESSORIES, INC.
NEW YORK,  NY,  US.
Initial Importer;  
I.M.T. ACCESSORIES, INC.
NEW YORK,  NY ,  US.
I.M.V. INTERNATIONAL CORP.
MAPLE GROVE,  MN,  US.
Initial Importer;  
IMV TECHNOLOGIES
L'AIGLE,  FR.
I.N., INC.
LOS ALAMITOS,  CA,  US.
Contract Manufacturer;   Manufacturer;  
I.N., INC.
LOS ALAMITOS,  CA ,  US.
I.O.C. EREDI (INDUSTRIA OTTICA COMELICESE)
S. NICOLO COMELICO,  IT.
Manufacturer;  
I.O.C. EREDI (INDUSTRIA OTTICA COMELICESE)
S. NICOLO COMELICO,  IT.
I.O.V.E.S. SRL
COMELICO BL,  IT.
Unregistered Foreign Lister;  
I.O.V.E.S. SRL
COMELICO BL,  IT.

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Last Modified: 29 April 2006
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