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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
KOSIM CHIROPRACTIC AND THERAPEUTIC SUPPLIES INC.
SCARBOROUGH, ONTARIO,  CA.
Manufacturer;  
KOSIM CHIROPRACTIC AND THERAPEUTIC SUPPLIES INC.
SCARBOROUGH, ONTARIO,  CA.
KOSMA-KARE CANADA, INC.
LONGUEUIL, QUEBEC,  CA.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KOSMA-KARE CANADA, INC.
LONGUEUIL, QUEBEC,  CA.
KOSMET, INC.
SANTA ANA,  CA,  US.
Initial Importer;  
KOSMET, INC.
SANTA ANA,  CA ,  US.
KOSMIC MEDICAL, INC.
ONTARIO,  CA,  US.
Remanufacturer;  
KOSMIC MEDICAL, INC.
ONTARIO,  CA ,  US.
KOSS DISTRIBUTING CO.
FULLERTON,  CA,  US.
Initial Importer;  
KOSS DISTRIBUTING CO.
FULLERTON,  CA ,  US.
KOSSAN GLOVES, INC. DBA SINTEX
HOUSTON,  TX,  US.
Initial Importer;  
SINTEX
HOUSTON,  TX ,  US.
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
KELANG, SELANGOR,  MY.
Manufacturer;  
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
KELANG, SELANGOR,  MY.
KOSSAN LATEX INDUSTRIES(M)SDN BHD
KLANG, SELANGOR,  MY.
Manufacturer;  
KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
KELANG, SELANGOR,  MY.
KOSWAY INDUSTRIES CO., LTD.
TUEN MUN, N.T.,  HK.
Manufacturer;  
KOSWAY INDUSTRIES CO., LTD.
TUEN MUN, N.T.,  HK.
KOTEC
DAEGU,  KS.
Manufacturer;  
KOTEC
DAEGU,  KS.
KOTEX ELECTRONICS COMPANY
KOWLOON, HONG KONG,  CH.
Contract Manufacturer;   Manufacturer;  
KOTEX ELECTRONICS COMPANY
KOWLOON, HONG KONG,  CH.
KOTTLER RESEARCH CORP.
VENTURA,  CA,  US.
Contract Manufacturer;  
KOTTLER RESEARCH CORP.
VENTURA,  CA ,  US.
KOTYS & CO.
POWELL,  OH,  US.
Initial Importer;  
KOTYS & CO.
POWELL,  OH ,  US.
KOUNG SHAN SHIRE LATEX GLOVES FACTORY
KOUNG SHAN SHIRE KIA,  CH.
Manufacturer;  
IRON WILL CO. LTD.
WANCHAI,  HK.
KOURE CORP.
FULLERTON,  CA,  US.
Initial Importer;  
KOURE CORP.
FULLERTON,  CA ,  US.
KOUSCO, INC.
TAIPEI,  TW.
Unregistered Foreign Lister;  
KOUSCO, INC.
TAIPEI,  TW.
KOUTARK CO., LTD.
TAIPEI, TAIWAN,  CH.
Unregistered Foreign Lister;  
KOUTARK CO., LTD.
TAIPEI, TAIWAN,  CH.
KOVA EQUIPMENT, LTD.
LADYSMITH BC,  CA.
Manufacturer;  
KOVA EQUIPMENT, LTD.
LADYSMITH BC,  CA.
KOVACS INVESTMENTS 620 (PTY) LTD, A SUBSIDIARY OF
SOMERSET WEST,  SF.
Contract Manufacturer;  
KOVACS INVESTMENTS 620 (PTY) LTD, A SUBSIDIARY OF
SOMERSET WEST,  SF.
KOVALIS, INC.
DENVER,  CO,  US.
Repackager/Relabeller;  
KOVALIS, INC.
DENVER,  CO ,  US.
KOVEN TECHNOLOGY, INC.
ST. LOUIS,  MO,  US.
Initial Importer;  
KOVEN TECHNOLOGY, INC.
ST. LOUIS,  MO ,  US.
KOVISION MFG., LTD.
KOWLOON,  CH.
Contract Manufacturer;   Manufacturer;  
KOVISION MFG., LTD.
KOWLOON,  CH.
KOWA CO. LTD.
CHUO-KU, TOKYO,  JA.
Manufacturer;  
KOWA CO. LTD.
NAGOYA, AICHI,  JA.
KOWA OPTIMED, INC.
TORRANCE,  CA,  US.
Initial Importer;  
KOWA OPTIMED, INC.
TORRANCE,  CA ,  US.
KOWLOON ETON TRADING CO.
KOWLOON,  HK.
Manufacturer;  
KOWLOON ETON TRADING CO.
KOWLOON,  HK.
KOYO DISPOSABLE GOODS CO., LTD.
KANAGAWA,  JA.
Unregistered Foreign Lister;  
KOYO DISPOSABLE GOODS CO., LTD.
KANAGAWA,  JA.
KP LENS EXPRESS
BRAMPTON, ONTARIO,  CA.
Contract Manufacturer;   Remanufacturer;  
KP LENS EXPRESS
BRAMPTON, ONTARIO,  CA.
KPNY (USA) LTD.
JACKSON HEIGHTS,  NY,  US.
Initial Importer;  
KPNY (USA) LTD.
JACKSON HEIGHTS,  NY ,  US.
K-PRO KOREA
GANGNAM-GU, SEOUL,  KS.
Manufacturer;  
K-PRO KOREA
GANGNAM-GU, SEOUL,  KS.
KPS & ASSOC., INC.
SALT LAKE CITY,  UT,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KPS & ASSOC., INC.
SALT LAKE CITY,  UT ,  US.
KRAMER SCIENTIFIC LABORATORY PRODUCTS CORP.
NORWOOD,  NJ,  US.
Initial Importer;   Manufacturer;  
KRAMER SCIENTIFIC LABORATORY CORPORATION
NORWOOD,  NJ ,  US.
KRAUSE SURGICAL INSTRUMENT CORP.
ST. LOUIS,  MO,  US.
Contract Manufacturer;   Manufacturer;  
KRAUSE SURGICAL INSTRUMENT CORP.
ST. LOUIS,  MO ,  US.
KREE TECHNOLOGIES USA, INC.
PLATTSBURGH,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KREE TECHNOLOGIES, INC.
ST. HUBERT, QUEBEC,  CA.
KREE TECHNOLOGIES, INC.
ST. HUBERT, QUEBEC,  CA.
Manufacturer;  
KREE TECHNOLOGIES, INC.
ST. HUBERT, QUEBEC,  CA.
KREISERS, INC.
SIOUX FALLS,  SD,  US.
Initial Importer;  
KREISERS, INC.
SIOUX FALLS,  SD ,  US.
KRISCHERCO WORLD-WIDE CO.
TAIPEI,  TW.
Unregistered Foreign Lister;  
KRISCHERCO WORLD-WIDE CO.
TAIPEI,  TW.
KRISHNA IMPORTS, INC.
LEXINGTON,  KY,  US.
Initial Importer;   Manufacturer;  
KRISHNA IMPORTS, INC.
LEXINGTON,  KY ,  US.
KRISTALIN
ALTAI TERRITORY,  RS.
Unregistered Foreign Lister;  
KRISTALIN
ALTAI TERRITORY,  RS.
KRISTI-CARE, INC.
LIMINGTON,  ME,  US.
Manufacturer;  
KRISTI-CARE, INC.
LIMINGTON,  ME ,  US.
KRITZER MARKETING
NEW YORK,  NY,  US.
Initial Importer;  
KRITZER MARKETING
NEW YORK,  NY ,  US.

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Last Modified: 29 April 2006
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