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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
KROLMAN CORP.
BOSTON,  MA,  US.
Initial Importer;   Repackager/Relabeller;  
KROLMAN CORP.
CHARLESTOWN,  MA ,  US.
KROMOPAN U.S.A., INC.
DES PLAINES,  IL,  US.
Initial Importer;  
KROMOPAN U.S.A., INC.
DES PLAINES,  IL ,  US.
KRONNER PROTOTYPES, INC.
ROSEBURG,  OR,  US.
Manufacturer;  
KRONNER PROTOTYPES, INC.
ROSEBURG,  OR ,  US.
KRONRING HB
VASTERAS,  SW.
Manufacturer;  
WERNER & KERSTIN HESSE
VASTERAS,  SW.
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
BOISE,  ID,  US.
Initial Importer;   Repackager/Relabeller;  
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
BOISE,  ID ,  US.
KRUPS NORTH AMERICA
CLOSTER,  NJ,  US.
Manufacturer;  
MOULINEX FAR EAST LTD.
KWAI CHUNG,  HK.
KRUSE TOOL & DIE, INC.
WARMINSTER,  PA,  US.
Contract Manufacturer;  
KRUSE TOOL & DIE, INC.
WARMINSTER,  PA ,  US.
KRYPTO INTERNATIONAL EXPORT, INC.
N.BAY VILLAGE,  FL,  US.
Initial Importer;  
KRYPTO INTERNATIONAL EXPORT, INC.
N.BAY VILLAGE,  FL ,  US.
KRYSTAL TRADING GROUP, INC.
PEMBROKE PINES,  FL,  US.
Initial Importer;  
KRYSTAL TRADING GROUP, INC.
PEMBROKE PINES,  FL ,  US.
KS MEDIZIN + LASER-TECHNIK
KOLBINGEN,  GM.
Manufacturer;  
KS CNC U. LASERTECHNIK E.K.
KOLBINGEN,  GM.
K'S MERCHANDISE MART, INC.
DECATUR,  IL,  US.
Initial Importer;  
K'S MERCHANDISE MART, INC.
DECATUR,  IL ,  US.
KSA INTERNATIONAL LTD
SINJHUANG CITY, TAIPEI HSIEN,  TW.
Foreign Exporter;  
KSA INTERNATIONAL LTD
SINJHUANG CITY, TAIPEI HSIEN,  TW.
K-SERA, INC.
VALENCIA,  CA,  US.
Manufacturer;  
K-SERA, INC.
VALENCIA,  CA ,  US.
KSH - PRODUCTOR OX
ESPOO,  FI.
Contract Manufacturer;  
KSH - PRODUCTOR OX
ESPOO,  FI.
KSK MEDICAL, LLC
IRVINE,  CA,  US.
Initial Importer;  
KSK MEDICAL, LLC
IRVINE,  CA ,  US.
K-STAT, L.L.C.
LAS VEGAS,  NV,  US.
Remanufacturer;  
K-STAT, L.L.C.
LAS VEGAS,  NV ,  US.
K-SYSTEMS, KIVEX BIOTEC LTD.
BIRKEROD,  DA.
Manufacturer;  
KIVEX HOLDING, KIVEX BIOTEC LTD.
BIRKEROD,  DA.
KT MEDICAL, INC.
KNOXVILLE,  TN,  US.
Initial Importer;   Manufacturer;  
KT MEDICAL, INC.
KNOXVILLE,  TN ,  US.
K-TEL INTERNATIONAL, LTD.
PLYMOUTH,  MN,  US.
Initial Importer;  
K-TEL INTERNATIONAL, LTD.
PLYMOUTH,  MN ,  US.
KTMAX INC.
SEOUL,  KS.
Manufacturer;  
KTMAX INC.
SEOUL,  KS.
KTNC CO., LTD
SEONGNAM-SI, KYUNGGI-DO,  KS.
Manufacturer;  
KTNC CO., LTD
SEONGNAM-SI, KYUNGGI-DO,  KS.
KUAN SHENG TRADING CO.,LTD.
HONG KONG,  CH.
Foreign Exporter;   Manufacturer;  
ETNA WORLDWIDE CORP.
NEW YORK,  NY ,  US.
KUAN YIN ENTERPRISES
HOLLYWOOD,  CA,  US.
Initial Importer;  
KUAN YIN ENTERPRISES LLC
HOLLYWOOD,  CA ,  US.
KUAN YUE INDUSTRIAL CO., LTD.
FENG-YUAN CITY, TAICHUNG HSIEN,  TW.
Unregistered Foreign Lister;  
KUAN YUE INDUSTRIAL CO., LTD.
FENG-YUAN CITY, TAICHUNG HSIEN,  TW.
KUANG HUI SPECTACLES FACTORY
TAINAN 700,  TW.
Manufacturer;  
RAYLUX TRANSNATIONAL IND.LTD.
KAOHSIUNG 800,  TW.
KUANG LUNG, INC.
HACIENDA HEIGHTS,  CA,  US.
Initial Importer;  
KUANG LUNG, INC.
HACIENDA HEIGHTS,  CA ,  US.
KUANG YAUH OPTICAL CO., LTD.
TAINAN,  TW.
Manufacturer;  
KUANG YAUH OPTICAL CO., LTD.
TAINAN,  TW.
KUANG YU METAL WORKING CO., LTD.
CHANG HUA HSIEN,  TW.
Unregistered Foreign Lister;  
KUANG YU METAL WORKING CO., LTD.
CHANG HUA HSIEN,  TW.
KUANN DAH INDUSTRY CO., LTD.
TAICHUNG HSIEN,  TW.
Manufacturer;  
KUANN DAH INDUSTRY CO., LTD.
TAICHUNG HSIEN,  TW.
KUBO CORPORATION PTY LTD
MELBOURNE,  AS.
Specification Developer;  
KUBO CORPORATION PTY LTD
MELBOURNE,  AS.
KUDOS ENT. INTL.
HONG KONG,  CH.
Manufacturer;  
KUDOS ENT. INTL.
HONG KONG,  CH.
KUE LUNG INDUSTRIAL LIMITED
GUANG DONG,  CH.
Manufacturer;  
JU LONG ENTERPRISE LIMITED CO.
GUANG DONG,  CH.
KUEI ENTERPRISES
LOS ANGELES,  CA,  US.
Initial Importer;  
KUEI ENTERPRISES
LOS ANGELES,  CA ,  US.
KUHN MEDIZINTECHNIK
DURBHEIM,  GM.
Manufacturer;  
MARKUS KUHN
DURBHEIM,  GM.
KUK JE CORP.
SASANG-KU, BUSAN,  KS.
Manufacturer;  
KUK JE CORP.
SASANG-KU, BUSAN,  KS.
KULLWELL MEDICAL, INC.
PORT MOODY, BRITISH COLUMBIA,  CA.
Manufacturer;  
KULLWELL MEDICAL, INC.
PORT MOODY, BRITISH COLUMBIA,  CA.
KUM HO OPTICAL
DAE GU,  KS.
Unregistered Foreign Lister;  
KUM HO OPTICAL
DAE GU,  KS.
KUM KWANG PLASTIC IND. CO.
A-SAN CITY, CHUNG NAM,  KS.
Unregistered Foreign Lister;  
KUM KWANG PLASTIC IND. CO.
A-SAN CITY, CHUNG NAM,  KS.
KUMHEUNG MEDICAL & MACHINE ELECTRONICS CO., LTD.
KYUNGKI-DO,  KS.
Unregistered Foreign Lister;  
KUMHEUNG MEDICAL & MACHINE ELECTRONICS CO., LTD.
KYUNGKI-DO,  KS.
KUMKANG SAN CORP.
DAEGU,  KS.
Contract Manufacturer;  
KUMKANG SAN CORP.
DAEGU,  KS.

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Last Modified: 29 April 2006
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