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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
KAI FU OPTICAL FTY. LTD.
KWUNG TONG, KOWLOON,  HK.
Manufacturer;  
KAI FU OPTICAL FACTORY LIMITED
KWUN TONG, KOWLOON,  HK.
KAI INDUSTRIES CO., LTD.
SEKI CITY, GIFU PREF.,  JA.
Manufacturer;  
KAI INDUSTRIES CO., LTD.
SEKI CITY, GIFU PREF.,  JA.
KAI SHUN OPTICAL MANUFACTORY
DONGGUAN,  CH.
Manufacturer;  
NEW SHUN TAT OPTICAL MANUFACTURING CO., LTD.
TOKWAWAN, KOWLOON,  HK.
KAI TAI OPTICAL MFG. CO. LTD.
HONG KONG,  HK.
Remanufacturer;  
KAI TAI OPTICAL MFG. CO. LTD.
HONG KONG,  HK.
KAI XING OPTICAL LIMITED
GUANGDONG,  CH.
Manufacturer;  
KAI XING OPTICAL LIMITED
GUANGDONG,  CH.
KAISER HAND- UND FUBPFLEGEINSTRUMENTE
FLOH,  GM.
Manufacturer;  
KAISER HAND- UND FUBPFLEGEINSTRUMENTE
FLOH,  GM.
KAISITE DENTAL, INC.
SHANGHAI,  CH.
Manufacturer;  
KAISITE DENTAL, INC.
SHANGHAI,  CH.
KAIXO CORP.
MIAMI,  FL,  US.
Initial Importer;  
KAIXO CORP.
MIAMI,  FL ,  US.
KAKINUMA MEDICAL, INC.
BUNKYO, TOKYO,  JA.
Manufacturer;  
ONDEKO CORP.
TOSHIMA, TOKYO,  JA.
KALAKI DESIGN
VALLESELLA DI CADORE, BL,  IT.
Manufacturer;  
KALAKIS HARALABOS
VALLESELLA DI CADORE, BL,  IT.
KALAMAZOO DENTAL SUPPLY
KALAMAZOO,  MI,  US.
Initial Importer;  
KALAMAZOO DENTAL SUPPLY
KALAMAZOO,  MI ,  US.
KALCO METALS, INC.
FARRELL,  PA,  US.
Contract Manufacturer;   Manufacturer;  
KALCO METALS, INC.
FARRELL,  PA ,  US.
KALE RESEARCH AND TECHNOLOGY
SPARTANBURG,  SC,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KALE RESEARCH AND TECHNOLOGY
SPARTANBURG,  SC ,  US.
KALEEB, INC.
LEVITTOWN,  PA,  US.
Initial Importer;  
KALEEB, INC.
LEVITTOWN,  PA ,  US.
KALLAM TRADERS
SIALKOT,  PK.
Unregistered Foreign Lister;  
KALLAM TRADERS
SIALKOT,  PK.
KALMED DENTAL PRODUCTS, INC.
MARIETTA,  GA,  US.
Initial Importer;  
KALMED DENTAL PRODUCTS, INC.
MARIETTA,  GA ,  US.
KALMED SUPPLY, INC.
SANTA ANA,  CA,  US.
Specification Developer;  
KALMED SUPPLY, INC.
SANTA ANA,  CA ,  US.
KALMED, INC.
PAWPAW,  MI,  US.
Specification Developer;  
KALMED, INC.
PAWPAW,  MI ,  US.
KALTEC PTY. LTD.
EDWARDSTOWN, SA,  AS.
Manufacturer;  
KALTEC PTY. LTD.
EDWARDSTOWN, SA,  AS.
KALTENBACH & VOIGT GMBH & CO. KG
BIBERACH,  GM.
Manufacturer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
KALTENBERG CASTLE BREWERY GMBH
GELTENDORF-KALTENBERG,  GM.
Manufacturer;  
KALTENBERG CASTLE BREWERY GMBH
GELTENDORF-KALTENBERG,  GM.
KALYX BIOSCIENCES, INC.
NEPEAN ONTARIO,  CA.
Unregistered Foreign Lister;  
KALYX BIOSCIENCES, INC.
NEPEAN ONTARIO,  CA.
KAM CHEONG PLASTIC FACTORY LTD.
WANCHAI,  HK.
Manufacturer;  
KAM CHEONG PLASTIC FACTORY LTD.
WANCHAI,  HK.
KAM LEE METAL & PLASTIC FTY. LTD.
TUEN MUN, NT,  HK.
Manufacturer;  
KAM LEE METAL & PLASTIC FTY. LTD.
TUEN MUN, NT,  HK.
KAM LONG IND. CO., LTD.
ZHUHAI CITY,GUANGDONG PROVINCE,  CH.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
KAM LONG IND. CO., LTD.
ZHUHAI CITY,GUANGDONG PROVINCE,  CH.
KAM MA TRADING CO.
TSUEN WAN, N.T. HONG KONG,  HK.
Unregistered Foreign Lister;  
KAM MA TRADING CO.
TSUEN WAN, N.T. HONG KONG,  HK.
KAM PAK PLASTIC & METAL MFY.
TSUEN WAN, N.T.,  HK.
Unregistered Foreign Lister;  
KAM PAK PLASTIC & METAL MFY.
TSUEN WAN, N.T.,  HK.
KAM PAK PLASTIC & METAL MFY. LTD.
GUANGDONG,  CH.
Manufacturer;  
KAM PAK PLASTIC & METAL MFY. LTD.
GUANGDONG,  CH.
KAMALTEK SERVICES
ONTARIO,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
KAMALTEK SERVICES
ONTARIO,  CA ,  US.
KAMBER CORPORATION
SAN JOSE,  CA,  US.
Initial Importer;   Specification Developer;  
KAMBER CORPORATION
SAN JOSE,  CA ,  US.
KAMED MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
Repackager/Relabeller;  
KAMED MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
KAM-G IMPORTS
CHICAGO,  IL,  US.
Initial Importer;  
KAM-G IMPORTS
CHICAGO,  IL ,  US.
KAMIYA BIOMEDICAL CO.
SEATTLE,  WA,  US.
Initial Importer;   Contract Manufacturer;   Repackager/Relabeller;  
KAMIYA BIOMEDICAL CO.
SEATTLE,  WA ,  US.
KAMIYA TSUSAN KAISHA, LTD.
TOKYO,  JA.
Repackager/Relabeller;  
KAMIYA TSUSAN KAISHA, LTD.
TOKYO,  JA.
KAN TECH INDUSTRIES, INC.
OVERLAND PARK,  KS,  US.
Initial Importer;  
KAN TECH INDUSTRIES, INC.
OVERLAND PARK,  KS ,  US.
KANAM LATEX INDUSTRIES PVT. LTD.
NAGERCOIL, TAMIL NADU,  IN.
Manufacturer;  
KANAM LATEX INDUSTRIES PVT. LTD.
KOTTAYAM, KERALA,  IN.
KANAM LATEX INDUSTRIES PVT. LTD.
NAGERCOIL, TAMIL NADU,  IN.
Manufacturer;  
KANAM LATEX INDUSTRIES PVT. LTD.
KOTTAYAM, KERALA,  IN.
KAND MEDICAL, INC.
VISTA,  CA,  US.
Initial Importer;  
KAND MEDICAL, INC.
VISTA,  CA ,  US.
KANDA OPTICAL CO., LTD.
OSAKA,  JA.
Manufacturer;  
KANDA OPTICAL CO., LTD.
OSAKA,  JA.
KANE DISTRIBUTION DC5
SCRANTON,  PA,  US.
Repackager/Relabeller;  
KANE DISTRIBUTION, INC
TAYLOR,  PA ,  US.

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Last Modified: 29 April 2006
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