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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
KODAK OPTICAL IND. CO.,LTD.
TAIPEI,  TW.
Unregistered Foreign Lister;  
KODAK OPTICAL IND. CO.,LTD.
TAIPEI,  TW.
KODAK-TROPHY
MARNE LA VALLEE CEDEX 2,  FR.
Manufacturer;  
EASTMAN KODAK COMPANY
ROCHESTER,  NY ,  US.
KODEX, INC.
PEMBROKE PINES,  FL,  US.
Initial Importer;  
KODEX, INC.
PEMBROKE PINES,  FL ,  US.
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
TIANJIN,  CH.
Manufacturer;  
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
TIANJIN,  CH.
KOFU FACTORY OF TERUMO CORP.
NAKAKOMA-GUN, YAMANASHI,  JA.
Manufacturer;  
TERUMO CORP.
SHIBUYA-KU, TOKYO,  JA.
KOH-I-NOOR
TRADATE,  IT.
Unregistered Foreign Lister;  
KOH-I-NOOR
TRADATE,  IT.
KOHLER CO.
KOHLER,  WI,  US.
Manufacturer;  
KOHLER CO.
KOHLER,  WI ,  US.
KOHLER MEDIZINTECHNIK GMBH & CO. KG
NEUHAUSEN,  GM.
Contract Manufacturer;   Manufacturer;  
KOHLER MEDIZINTECHNIK GMBH & CO. KG
NEUHAUSEN,  GM.
KOHLL'S PHARMACY & HOMECARE, INC.
OMAHA,  NE,  US.

KOHLL'S PHARMACY & HOMECARE, INC.
OMAHA,  NE ,  US.
KOINONIA TECHNOLOGY & TRADING, INC.
NEW MARKET,  MD,  US.
Specification Developer;  
KOINONIA TECHNOLOGY & TRADING, INC.
NEW MARKET,  MD ,  US.
KOJIN OPTICAL TRADING CO.
DAEGU,  KS.
Manufacturer;  
KOJIN OPTICAL TRADING CO.
DAEGU,  KS.
KOKEN CO., LTD.
TOSHIMA-KU, TOKYO,  JA.
Contract Manufacturer;   Manufacturer;  
KOKEN CO., LTD.
TOSHIMA-KU, TOKYO,  JA.
KOKO LAND, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
KOKO LAND, INC.
LOS ANGELES,  CA ,  US.
KO-LASER
GREENWOOD,  IN,  US.
Initial Importer;  
KO-LASER
GREENWOOD,  IN ,  US.
KOLBERG OCULAR PRODUCTS, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
KOLBERG OCULAR PRODUCTS, INC.
SAN DIEGO,  CA ,  US.
KOLE IMPORTS, INC.
CARSON,  CA,  US.
Initial Importer;  
KOLE IMPORTS, INC.
CARSON,  CA ,  US.
KOLLMAR MED, INC.
BOZEMAN,  MT,  US.
Repackager/Relabeller;  
KOLLMAR MED, INC.
BOZEMAN,  MT ,  US.
KOLPLAST COMERCIAL E INDUSTRIAL LTDA
SAO PAULO,  BR.
Manufacturer;  
KOLPLAST COMERCIAL E INDUSTRIAL LTDA
SAO PAULO,  BR.
KOLVIN INDUSTRIES LTD.
KOWLOON,  HK.
Manufacturer;  
KOLVIN INDUSTRIES LTD.
KOWLOON,  HK.
KOLVIN INDUSTRIES LTD.
KOWLOON,  HK.
Unregistered Foreign Lister;  
KOLVIN INDUSTRIES LTD.
KOWLOON,  HK.
KOMACO RUBBER GLOVES INDUSTRIES SDN. BHD.
30250 IPOH,  MY.
Manufacturer;  
KOMACO RUBBER GLOVES INDUSTRIES SDN. BHD.
30250 IPOH,  MY.
KOMED
BUDAPEST,  HU.
Unregistered Foreign Lister;  
KOMED
BUDAPEST,  HU.
KOMED CO., LTD
SUNGNAM-CITY, KYUNGKI-DO,  KS.
Manufacturer;  
KOMED CO., LTD
SUNGNAM-CITY, KYUNGKI-DO,  KS.
KOMORI KOGYO CO., LTD.
KOTU, YAMANASHI,  JA.
Unregistered Foreign Lister;  
KOMORI KOGYO CO., LTD.
KOTU, YAMANASHI,  JA.
KOMURA CORPORATION
YAO-CITY OSAKA,  JA.
Manufacturer;  
KOMURA CORPORATION
YAO-CITY OSAKA,  JA.
KONAN MEDICAL, INC.
HYOGO,  JA.
Manufacturer;  
KONAN MEDICAL, INC.
HYOGO,  JA.
KONG FAI NON-WOVEN ARTICLES (SHANGHAI) CO., LTD.
SHANGHAI,  CH.
Manufacturer;  
KONG FAI NON-WOVEN ARTICLES (SHANGHAI) CO., LTD.
SHANGHAI,  CH.
KONG LUNG MANUFACTORY LTD.
KOWLOON, HONG KONG,  CH.
Unregistered Foreign Lister;  
KONG LUNG MANUFACTORY LTD.
KOWLOON, HONG KONG,  CH.
KONICA MEDICAL IMAGING, INC.
LAKE FORREST,  CA,  US.
Initial Importer;  
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
WAYNE,  NJ ,  US.
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
TOKYO,  JA.
Manufacturer;   Specification Developer;  
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
TOKYO,  JA.
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
TOKYO,  JA.
Manufacturer;   Specification Developer;  
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
TOKYO,  JA.
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
YAMANASHI,  JA.
Manufacturer;  
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
TOKYO,  JA.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
MAHWAH,  NJ,  US.
Initial Importer;  
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
WAYNE,  NJ ,  US.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
NORCROSS,  GA,  US.
Initial Importer;  
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
WAYNE,  NJ ,  US.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
WAYNE,  NJ,  US.
Initial Importer;  
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
WAYNE,  NJ ,  US.
KONICA MINOLTA PHOTO IMAGING U.S.A., INC.
MAHWAH,  NJ,  US.
Initial Importer;  
KONICA MINOLTA PHOTO IMAGING U.S.A., INC.
MAHWAH,  NJ ,  US.
KONICA MINOLTA SENSING, INC.
TOYOKAWA, AICHI,  JA.
Manufacturer;  
KONICA MINOLTA SENSING, INC.
SAKAI, OSAKA,  JA.
KONICA MINOLTA TECHNOPRODUCT CO., LTD.
SAYAMA-SHI; SAITAMA-KEN,  JA.
Manufacturer;  
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
TOKYO,  JA.
KONIGSBERG INSTRUMENTS, INC.
PASADENA,  CA,  US.
Manufacturer;  
KONIGSBERG INSTRUMENTS, INC.
PASADENA,  CA ,  US.
KONIK & CO., INC.
SKOKIE,  IL,  US.
Initial Importer;  
KONIK & CO., INC.
SKOKIE,  IL ,  US.

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Last Modified: 29 April 2006
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