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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
KONSON NORTH AMERICA
BRAMPTON, ONTARIO,  CA.
Unregistered Foreign Lister;  
KONSON NORTH AMERICA
BRAMPTON, ONTARIO,  CA.
KONSYL PHARMACEUTICALS, INC.
EASTON,  MD,  US.
Manufacturer;  
KONSYL PHARMACEUTICALS, INC.
EASTON,  MD ,  US.
KONTAKT US INTERNATIONAL
GREAT NECK,  NY,  US.
Initial Importer;  
KONTAKT US INTERNATIONAL
GREAT NECK,  NY ,  US.
KONTRON INSTRUMENTS AG
BASEL, SCHWEIZ,  GM.
Unregistered Foreign Lister;  
KONTRON INSTRUMENTS AG
BASEL, SCHWEIZ,  GM.
KONTRON MEDICAL SYSTEMS SAS
PLAISIR,  FR.
Manufacturer;  
FUKUDA DENSHI CO., LTD.
TOKYO,  JA.
KONTRON MEDICAL, LLC.
WANAQUE,  NJ,  US.
Initial Importer;  
KONTRON MEDICAL, LLC.
WANAQUE,  NJ ,  US.
KONTUR KONTACT LENS CO., INC.
HERCULES,  CA,  US.
Manufacturer;  
KONTUR KONTACT LENS CO., INC.
HERCULES,  CA ,  US.
KOO AMERICAS, INC.
ALPHARETTA,  GA,  US.
Initial Importer;  
KOO AMERICAS, INC.
ALPHARETTA,  GA ,  US.
KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD.
SHANGHAI,  CH.
Manufacturer;  
KOO MFG, INC.
TAIPEI COUNTY,  TW.
KOO MFG, INC.
TAIWAN COUNTY,  TW.
Manufacturer;  
KOO MFG, INC.
TAIPEI COUNTY,  TW.
KOOJOO TRADING COMPANY
GIMPO-CITY, KYUNGGI-DO,  KS.
Manufacturer;  
KOOJOO TRADING COMPANY
GIMPO CITY, KYUNGGI-DO,  KS.
KOOKS CO., LTD.
TOKYO,  JA.
Foreign Exporter;  
KOOKS CO., LTD.
TOKYO,  JA.
KOOL WORLD, INC.
NEW YORK,  NY,  US.
Initial Importer;  
KOOL WORLD, INC.
NEW YORK,  NY ,  US.
KOOLER RUBBER & PLASTICS INDUSTRIAL CO., LTD.
PEI TOU TOWN, HSIEN,  TW.
Manufacturer;  
P.M.LEE
PEI TOU TOWN, HSIEN,  TW.
KOOLIT CLOTHING CO.
BROOKVALE, NSW,  AS.
Manufacturer;  
KOOLIT CLOTHING CO.
BROOKVALE, NSW,  AS.
KOOLLOOK INTERNATIONAL, LTD.
SHANGHAI,  CH.
Manufacturer;  
KOOLLOOK INTERNATIONAL, LTD.
SHANGHAI,  CH.
KOON SENG SDN.BHD
MUAR JOHOR,  MY.
Manufacturer;  
KOON SENG SDN.BHD
MUAR, JOHOR,  MY.
KORCHEK TECHNOLOGIES, LLC
SHELTON,  CT,  US.
Manufacturer;  
KORCHEK TECHNOLOGIES, LLC
SHELTON,  CT ,  US.
KOREA BIO TECHNOLOGY ENT.
SEONGNAM-CITY, GYEONGGI-DO,  KS.
Manufacturer;  
KOREA BIO TECHNOLOGY ENT.
SEONGNAM-CITY, GYEONGGI-DO,  KS.
KOREA J-TECH CO., LTD
JEONJU, CHONBUK,  KS.
Manufacturer;  
KOREA J-TECH CO., LTD
JEONJU, CHONBUK,  KS.
KOREA MEDICAL CORP.
DAE DUCK, DAE JEOUN,  KS.
Contract Manufacturer;   Contract Sterilizer;  
KOREA MEDICAL CORP.
DAE DUCK, DAE JEOUN,  KS.
KOREA MEDICAL CORP.
KYUNGKI-DO,  KS.
Unregistered Foreign Lister;  
KOREA MEDICAL CORP.
KYUNGKI-DO,  KS.
KOREA MEDICOM
SEOUL,  KS.
Manufacturer;  
KOREA MEDICOM
SEOUL,  KS.
KOREA MEDILIND CO. LTD
KIMHAE-SI KYUNGNAM,  KS.
Manufacturer;  
KOREA MEDILIND CO. LTD
KIMHAE-SI KYUNGNAM,  KS.
KOREA MIRACLE HEALTH WATER
YEONGDEUNGPO-GU, SEOUL,  KS.
Manufacturer;  
KOREA MIRACLE HEALTH WATER
YEONGDEUNGPO-GU, SEOUL,  KS.
KOREA MOKCHO CO., LTD.
DAEJEON, CHUNGCHEONGNAM-DO,  KS.
Manufacturer;   Specification Developer;  
KOREA MOKCHO CO., LTD.
DAEJEON, CHUNGCHEONGNAM-DO,  KS.
KOREA NEW START CO., LTD.
TEAGU, KYUNG SANG BUK DO,  KS.
Manufacturer;  
KOREA NEW START CO., LTD.
TEAGU, KYUNG SANG BUK DO,  KS.
KOREA OPTICAL CO. LTD.
TAEGU,  KS.
Manufacturer;  
KOREA OPTICAL CO. LTD.
TAEGU,  KS.
KOREA OPTICAL CO., LTD.
TAEJON,  KS.
Manufacturer;  
KOREA OPTICAL CO., LTD.
TAEJON,  KS.
KOREA POLYLENS CO., LTD.
WONJU SI, KANGWON-DO,  KS.
Manufacturer;  
KOREA POLYLENS CO., LTD.
WONJU SI, KANGWON-DO,  KS.
KOREA SAITO MEDICAL IND. CO., LTD.
KIMPO-CITY, KYUNGGI-DO,  KS.
Manufacturer;  
KOREA SAITO MEDICAL IND. CO., LTD.
KIMPO-CITY, KYUNGGI-DO,  KS.
KOREA TECHMA CO.
KYUNG KI DO,  KS.
Manufacturer;  
KOREA TECHMA CO.
KYUNG KI DO,  KS.
KOREAN ACUPUNCTURE CLINIC
BROOKSVILLE,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
KOREAN ACUPUNCTURE CLINIC
BROOKSVILLE,  FL ,  US.
KOROS USA, INC.
MOORPARK,  CA,  US.
Manufacturer;  
KOROS USA, INC.
MOORPARK,  CA ,  US.
KORR MEDICAL TECHNOLOGIES, INC.
SALT LAKE CITY,  UT,  US.
Manufacturer;  
KORR MEDICAL TECHNOLOGIES, INC.
SALT LAKE CITY,  UT ,  US.
KOSAN CORP.
TOKYO 116,  JA.
Specification Developer;  
KOSAN CORP.
TOKYO 116,  JA.
KOSCHER & WURTZ GMBH
SPAICHINGEN,  GM.
Manufacturer;  
KOSCHER & WURTZ GMBH
SPAICHINGEN,  GM.
KOSEL INDUSTRIES SDN BHD
SEBERANG PERAI PULAU PINANG,  MY.
Manufacturer;  
KOSEL INDUSTRIES SDN BHD
SEBERANG PERAI PULAU PINANG,  MY.
KOSHIN CO., LTD.
GUNMA PREF.,  JA.
Manufacturer;  
SHIN-ICHI MIYAZAWA
GUNMA PREF.,  JA.
KOSHIYA CO., LTD.
KANAZAWA, ISHIKAWA,  JA.
Unregistered Foreign Lister;  
KOSHIYA CO., LTD.
KANAZAWA, ISHIKAWA,  JA.

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Last Modified: 29 April 2006
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