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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
KARE KITS INC.
VANCOUVER, BC,  CA.
Repackager/Relabeller;  
KARE KITS INC.
VANCOUVER, BC,  CA.
KARE MEDICAL, INC.
KINSTON,  NC,  US.
Initial Importer;  
KARE MEDICAL, INC.
KINSTON,  NC ,  US.
KARE ORTHOPEDICS
GREENOCK,  UK.
Unregistered Foreign Lister;  
KARE ORTHOPEDICS
GREENOCK,  UK.
KARECO INTL., INC.
GREEN BROOK,  NJ,  US.
Initial Importer;  
KARECO INTL., INC.
GREEN BROOK,  NJ ,  US.
KAREL MANIFATTURA TESSILE
PRATTO,  IT.
Unregistered Foreign Lister;  
KAREL SRL MANIFATTURA TESSILE
PRATTO,  IT.
KAREL SRL MANIFATTURA TESSILE
MARCO LOTTO, PRATO,  IT.
Manufacturer;  
KAREL SRL MANIFATTURA TESSILE
PRATTO,  IT.
KAREN CARSON CREATIONS
DAYTON,  OH,  US.
Initial Importer;  
KAREN CARSON CREATIONS
DAYTON,  OH ,  US.
KARETECH, LLC.
SAN FRANCISCO,  CA,  US.
Specification Developer;  
KARETECH, LLC.
SAN FRANCISCO,  CA ,  US.
KAREWAY PRODUCT, INC.
GARDENA,  CA,  US.
Initial Importer;  
KAREWAY PRODUCT, INC.
GARDENA,  CA ,  US.
KAREX INDUSTRIES SDN BHD
PONTIAN, JOHOR,  MY.
Manufacturer;  
KAREX INDUSTRIES SDN BHD
PONTIAN, JOHOR,  MY.
KARIM'S TEXTILE AND APPAREL MEXICO
CAMPECHE CAMP. CP,  MX.
Manufacturer;   Specification Developer;  
LUCEDALE SPORTSWEAR
LUCEDALE,  MS ,  US.
KARL AUGUST HUBER
TUTTLINGEN,  GM.
Manufacturer;  
KARL AUGUST HUBER
TUTTLINGEN,  GM.
KARL BERG GMBH
ENGEN,  GM.
Manufacturer;  
KARL BERG GMBH
ENGEN,  GM.
KARL BRUGGER
DURBHEIM,  GM.
Manufacturer;  
KARL BRUGGER
DURBHEIM,  GM.
KARL HAMMACHER GMBH
SOLINGEN,  GM.
Contract Manufacturer;   Manufacturer;  
KARL HAMMACHER GMBH
SOLINGEN,  GM.
KARL ILG INSTRUMENT CO.
ST. CHARLES,  IL,  US.
Manufacturer;  
KARL ILG INSTRUMENT CO.
ST. CHARLES,  IL ,  US.
KARL KAPS GMBH & CO. KG
ASSLAR,  GM.
Manufacturer;  
KARL KAPS GMBH & CO. KG
ASSLAR,  GM.
KARL KLAPPENECKER
TUTTLINGEN 16,  GM.
Manufacturer;  
KARL KLAPPENECKER
TUTTLINGEN 16,  GM.
KARL KOHLER
TUTTLINGEN, BADEN-WURTTEMBERG,  GM.
Manufacturer;  
KARL KOHLER
TUTTLINGEN, BADEN-WURTTEMBERG,  GM.
KARL LEIBINGER GMBH U. CO. KG
MUHLHEIM,  GM.
Manufacturer;  
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
MUHLHEIM,  GM.
KARL OTTO BRAUN KG
PFALZ,  GM.
Manufacturer;  
KARL OTTO BRAUN KG
PFALZ,  GM.
KARL REICHLE & CO.
TUTTLINGEN,  GM.
Manufacturer;  
KARL REICHLE & CO.
TUTTLINGEN,  GM.
KARL SCHUMACHER DENTAL INSTRUMENTS CO., INC.
SOUTHAMPTON,  PA,  US.
Initial Importer;  
KARL SCHUMACHER DENTAL INSTRUMENTS CO., INC.
SOUTHAMPTON,  PA ,  US.
KARL STEPPACHER
TUTTLINGEN,  GM.
Manufacturer;  
KARL STEPPACHER
TUTTLINGEN,  GM.
KARL STORZ ENDOSCOPIA LATINO AMERICA, INC.
MIAMI,  FL,  US.
Initial Importer;  
KARL STORZ VERITRIEBS-GMBH
TUTTLINGEN, BW,  GM.
KARL STORZ ENDOSCOPY-AMERICA, INC.
CHARLTON,  MA,  US.
Initial Importer;   Repackager/Relabeller;  
KARL STORZ VERITRIEBS-GMBH
TUTTLINGEN, BW,  GM.
KARL STORZ ENDOVISION, INC.
CHARLTON,  MA,  US.
Manufacturer;  
STORZ ENDOSKOP GMBH
SCHAFFHAUSEN,  SZ.
KARL STORZ GMBH & CO. KG
TUTTLINGEN,  GM.
Manufacturer;   Specification Developer;  
KARL STORZ VERITRIEBS-GMBH
TUTTLINGEN, BW,  GM.
KARL STORZ IMAGING, INC.
GOLETA,  CA,  US.
Contract Manufacturer;   Manufacturer;  
KARL STORZ IMAGING, INC.
GOLETA,  CA ,  US.
KARL STORZ LITHOTRIPSY-AMERICA, INC.
KENNESAW,  GA,  US.
Initial Importer;  
KARL STORZ ENDOSCOPY-AMERICA, INC.
CULVER CITY,  CA ,  US.
KARL STORZ SPORTS MEDICINE, INC.
LITTLETON,  MA,  US.
Initial Importer;  
KARL STORZ SPORTS MEDICINE, INC.
LITTLETON,  MA ,  US.
KARLIN DENTAL DISTRIBUTORS INC.
BRANTFORD, ONTARIO,  CA.
Foreign Exporter;  
KARLIN DENTAL DISTRIBUTORS INC.
BRANTFORD, ONTARIO,  CA.
KARLIN TECHNOLOGY, INC.
ARVIN,  CA,  US.
Specification Developer;  
KARLIN TECHNOLOGY, INC.
ARVIN,  CA ,  US.
KARMA MEDICAL PRODUCTS CO., LTD.
CHIA-YI HSIEN,  TW.
Contract Manufacturer;   Manufacturer;  
KARMA MEDICAL PRODUCTS CO., LTD.
CHIA-YI HSIEN,  TW.
KARMAN HEALTHCARE, INC.
CITY OF INDUSTRY,  CA,  US.
Initial Importer;  
KARMAN HEALTHCARE, INC.
CITY OF INDUSTRY,  CA ,  US.
KARWOSKI DENTAL
PLEASANT HILL,  CA,  US.
Manufacturer;  
KARWOSKI DENTAL
PLEASANT HILL,  CA ,  US.
KASEI OPTONIX, LTD.
ODAWARA, KANAGAWA,  JA.
Contract Manufacturer;   Manufacturer;  
MITSUBISHI CHEMICAL CORP.
MINATO-KU, TOKYO,  JA.
KASH SALES (U.S.A.), INC.
POMPTON PLAINS,  NJ,  US.
Initial Importer;  
KASH SALES (U.S.A.), INC.
POMPTON PLAINS,  NJ ,  US.
KASHMIR SURGICAL CO.
SIALKOT,  PK.
Manufacturer;  
KASHMIR SURGICAL CO.
SIALKOT,  PK.
KASHMIR SURGICAL WORKS
AMBALA CITY, HARYANA,  IN.
Manufacturer;  
KASHMIR SURGICAL WORKS
AMBALA CITY, HARYANA,  IN.

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Last Modified: 29 April 2006
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