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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
KLUGE DESIGN, INC.
ROGERS,  MN,  US.
Contract Manufacturer;  
KLUGE DESIGN, INC.
ROGERS,  MN ,  US.
KLYSTRA
KAILUA-KONA,  HI,  US.
Initial Importer;  
KLYSTRA
KAILUA-KONA,  HI ,  US.
KM INSTRUMENTS
TUCSON,  AZ,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
KM INSTRUMENTS
TUCSON,  AZ ,  US.
KM SUPPLIES
LOS ANGELES,  CA,  US.
Initial Importer;  
KM SUPPLIES
LOS ANGELES,  CA ,  US.
KMA REMARKETING CORP.
DUBOIS,  PA,  US.
Initial Importer;  
KMA REMARKETING CORP.
DUBOIS,  PA ,  US.
KMA REMARKETING CORP.
DUBOIS,  PA,  US.
Remanufacturer;   Repackager/Relabeller;  
KMA REMARKETING CORP.
DUBOIS,  PA ,  US.
KMART CORP.
HOFFMAN ESTATES,  IL,  US.
Initial Importer;  
KMART CORP.
HOFFMAN ESTATES,  IL ,  US.
KMC SYSTEMS, INC.
MERRIMACK,  NH,  US.
Initial Importer;   Contract Manufacturer;  
KOLLSMAN, INC.
MERRIMACK,  NH ,  US.
K-MED, INC.
DANBURY,  CT,  US.
Specification Developer;   Repackager/Relabeller;  
K-MED, INC.
DANBURY,  CT ,  US.
KMEDIC EUROPE GMBH, PILLING WECK, TELEFLEX MEDICAL
TUTTLINGEN,  GM.
Foreign Exporter;   Manufacturer;  
TELEFLEX MEDICAL
BANNOCKBURN,  IL ,  US.
KMEDIC, TELEFLEX MEDICAL
NORTHVALE,  NJ,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
TELEFLEX MEDICAL
BANNOCKBURN,  IL ,  US.
KMI CO., LTD.
SEOUL,  KS.
Manufacturer;  
KMI CO., LTD.
SEOUL,  KS.
KMI KOLSTER METHODS, INC.
CORONA,  CA,  US.
Contract Manufacturer;   Manufacturer;  
KMI KOLSTER METHODS, INC.
CORONA,  CA ,  US.
KMI SURGICAL LTD.
DOWNINGTOWN,  PA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KMI SURGICAL LTD.
DOWNINGTOWN,  PA ,  US.
KMQ FASHION, INC.
LAREDO,  TX,  US.
Initial Importer;  
KMQ FASHION, INC.
LAREDO,  TX ,  US.
KNAB MEDICAL ASSOCIATES, INC.
COLUMBUS,  OH,  US.
Initial Importer;  
KNAB MEDICAL ASSOCIATES, INC.
COLUMBUS,  OH ,  US.
KNEEBOURNE THERAPEUTIC, LLC
NOBLESVILLE,  IN,  US.
Initial Importer;   Manufacturer;  
KNEEBOURNE THERAPEUTIC, LLC
NOBLESVILLE,  IN ,  US.
KNIGHT ELECTRONICS
DALLAS,  TX,  US.
Initial Importer;  
KNIGHT ELECTRONICS
DALLAS,  TX ,  US.
KNIGHTON LTD.
BUCKHURST HILL, ESSEX,  UK.
Unregistered Foreign Lister;  
KNIGHTON LTD.
BUCKHURST HILL, ESSEX,  UK.
KNIGHTS INTERNATIONAL
LAKE ST. LOUIS,  MO,  US.
Initial Importer;  
KNIGHTS INTERNATIONAL
LAKE ST. LOUIS,  MO ,  US.
KNIT-RITE, INC.
KANSAS CITY,  KS,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KNIT-RITE, INC.
KANSAS CITY,  KS ,  US.
KNITTEL GLASER
BRAUNSCHWEIG,  GM.
Unregistered Foreign Lister;  
KNITTEL GLASER
BRAUNSCHWEIG,  GM.
KNIVES & THINGS
BALTIMORE,  MD,  US.
Initial Importer;  
KNIVES & THINGS
BALTIMORE,  MD ,  US.
KNOXVILLE MEDICAL, INC.
MIAMI,  FL,  US.
Initial Importer;  
KNOXVILLE MEDICAL, INC.
MIAMI,  FL ,  US.
KO CHIEN ELECTRIC CO., LTD.
TAIPEI COUNTY,  TW.
Manufacturer;  
KO CHIEN ELECTRIC CO., LTD.
TAIPEI COUNTY,  TW.
KO JIH ENT. CO., LTD.
KAOHELUNG HSIEN,  TW.
Unregistered Foreign Lister;  
KO JIH ENT. CO., LTD.
KAOHELUNG HSIEN,  TW.
KO SING OPTICAL FACTORY
LONGGANG, SHENZHEN,  CH.
Contract Manufacturer;  
KO SING OPTICAL FACTORY
LONGGANG, SHENZHEN,  CH.
KOADAK OPTICAL INDUSTRIAL CO., LTD.
TAIPEI,  TW.
Manufacturer;  
KOADAK OPTICAL INDUSTRIAL CO., LTD.
TAIPEI,  TW.
KOAM ENTERPRISE, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
KOAM ENTERPRISE, INC.
LOS ANGELES,  CA ,  US.
KO-AM TRADE PROMOTION, INC.
WEST COVINA,  CA,  US.
Initial Importer;  
KO-AM TRADE PROMOTION, INC.
WEST COVINA,  CA ,  US.
KOBAYASHI HEALTHCARE, LLC
WAYNE,  PA,  US.
Initial Importer;  
KOBAYASHI HEALTHCARE, LLC
WAYNE,  PA ,  US.
KOBAYASHI PHARMACEUTICAL CO., LTD.
YODOGAWA-KU, OSAKA,  JA.
Manufacturer;  
KOBAYASHI PHARMACEUTICAL CO., LTD.
YODOGAWA-KU, OSAKA,  JA.
KOBAYASHI SHOJI K.K.
UCHIKANDA, CHIYODA-KU TOKYO,  JA.
Contract Manufacturer;   Repackager/Relabeller;  
KOBAYASHI SHOJI K.K.
UCHIKANDA, CHIYODA-KU TOKYO,  JA.
KOBY SURGICAL
HOUSTON,  TX,  US.
Specification Developer;  
KOBY INDUSTRIES, L.P.
HOUSTON,  TX ,  US.
KOCO TRADING
LOS ANGELES,  CA,  US.
Initial Importer;  
KOCO TRADING
LOS ANGELES,  CA ,  US.
KODA OPTICAL PRODUCTS, LTD.
DONGGUAN GUANGDONG,  CH.
Manufacturer;  
KODA OPTICAL PRODUCTS, LTD.
DONGGUAN GUANGDONG,  CH.
KODAK (CHINA) COMPANY LIMITED
XIAMEN, FUJIAN,  CH.
Manufacturer;  
EASTMAN KODAK COMPANY
ROCHESTER,  NY ,  US.
KODAK DE MEXICO, S.A. DE C.V.
GUADALAJARA, JALISCO,  MX.
Manufacturer;  
EASTMAN KODAK COMPANY
ROCHESTER,  NY ,  US.
KODAK ELECTRONIC PRODUCTS (SHANGHAI) CO., LTD.
SHANGHAI, PUDONG,  CH.
Manufacturer;  
EASTMAN KODAK COMPANY
ROCHESTER,  NY ,  US.
KODAK INDUSTRIE
CEDEX,  FR.
Manufacturer;  
EASTMAN KODAK COMPANY
ROCHESTER,  NY ,  US.

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Last Modified: 29 April 2006
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