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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
KX MEDICAL LLC
MIAMI,  FL,  US.
Initial Importer;  
KX MEDICAL LLC
MIAMI,  FL ,  US.
KY INTL., INC.
MIAMI,  FL,  US.
Initial Importer;  
KY INTL., INC.
MIAMI,  FL ,  US.
KYE SYSTEMS CORPORATION
SAN CHUNG, TAIPEI HSIEN,  TW.
Contract Manufacturer;  
KYE SYSTEMS CORPORATION
SAN CHUNG, TAIPEI HSIEN,  TW.
KYK, INC.
SEOUL,  KS.
Manufacturer;  
KYK, INC.
SEOUL,  KS.
KYLE PHARMACEUTICALS LTD., N.A.
LOS ANGELES,  CA,  US.
Specification Developer;  
KYLE PHARMACEUTICALS LTD., N.A.
LOS ANGELES,  CA ,  US.
KYLIE ENTERPRISE CO. LTD.
YUNG-HO, TAIPEI HSIEN,  TW.
Manufacturer;  
KYLIE ENTERPRISE CO. LTD.
YUNG-HO, TAIPEI HSIEN,  TW.
KYOCARE HEALTH CO.
HENDERSON,  NV,  US.
Manufacturer;  
KYOCARE HEALTH CO.
HENDERSON,  NV ,  US.
KYOCARE SCIENTIFIC, INC.
TORONTO, ONTARIO,  CA.
Manufacturer;  
KYOCARE SCIENTIFIC, INC.
HENDERSON,  NV ,  US.
KYOCERA CORP.
GAMO-GUN, SHIGA-KEN,  JA.
Manufacturer;  
KYOCERA CORP.
KYOTO,  JA.
KYOCERA OPTICS, INC.
SOMERSET,  NJ,  US.
Initial Importer;  
KYOCERA OPTICS, INC.
SOMERSET,  NJ ,  US.
KYONG-BUK TRADING CORP.
DAEGU,  KS.
Manufacturer;   Remanufacturer;  
KYONG-BUK TRADING CORP.
DAEGU,  KS.
KYORITU PLASTICS CO., LTD.
IWAKUNI-SHI, YAMAGUCHI-KEN,  JA.
Manufacturer;  
KYORITU PLASTICS CO., LTD.
IWAKUNI-SHI, YAMAGUCHI-KEN,  JA.
KYOUNG IL HIGHTECH CO., LTD.
BUSAN CITY, KYOUNG-NAM,  KS.
Manufacturer;  
KYOUNG IL HIGHTECH CO., LTD.
BUSAN CITY, KYOUNG-NAM,  KS.
KYOWA HAKKO U.S.A., INC.
NEW YORK,  NY,  US.
Initial Importer;  
KYOWA AMERICA, INC.
NEW YORK,  NY ,  US.
KYOWA MEDEX CO., LTD.
SUNTO-GUN, SHIZUOKA-KEN,  JA.
Contract Manufacturer;   Manufacturer;  
KYOWA MEDEX CO., LTD.
TOKYO,  JA.
KYOWA OPTICAL CO., LTD.
SABAE-CITY,  JA.
Manufacturer;  
GONSHI KAMON
SABAE-CITY,  JA.
KYOWA OPTICAL CO., LTD.
OSAKA-547,  JA.
Manufacturer;  
KYOWA OPTICAL CO., LTD.
OSAKA-547,  JA.
KYOWA TEXTILE CO., LTD.
NYUGUN, FUKUIKEN,  JA.
Manufacturer;  
KYOWA TEXTILE CO., LTD.
NYUGUN, FUKUIKEN,  JA.
KYOWA TEXTILE USA, INC.
TORRANCE,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
KYOWA TEXTILE USA, INC.
TORRANCE,  CA ,  US.
KYOWA, LTD.
IZUMISANO-CITY, OSAKA,  JA.
Contract Manufacturer;  
KYOWA, LTD.
OSAKA-CITY, OSAKA,  JA.
KYOWON L & C CO., LTD.
SEOUL,  KS.
Manufacturer;  
KYOWON L & C CO., LTD.
SEOUL,  KS.
KYPHON, INC.
SUNNYVALE,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
KYPHON, INC.
SUNNYVALE,  CA ,  US.
KYRO MFG. CO.
FT. WORTH,  TX,  US.
Manufacturer;  
KYRO MFG. CO.
FT. WORTH,  TX ,  US.
KYRON CLINICAL IMAGING, INC.
WAUWATOSA,  WI,  US.
Manufacturer;   Specification Developer;  
KYRON CLINICAL IMAGING, INC.
WAUWATOSA,  WI ,  US.
KYTHAY TRADING CO.
BALDWIN PARK,  CA,  US.
Initial Importer;  
KYTHAY TRADING CO.
BALDWIN PARK,  CA ,  US.
KYUNG CHANG OPTICAL CO., LTD.
DAEGU,  KS.
Manufacturer;  
KYUNG CHANG OPTICAL CO., LTD.
DAEGU,  KS.
KYUNG DONG OPTICAL CO.
BUK-KU, DAEGU,  KS.
Unregistered Foreign Lister;  
KYUNG DONG OPTICAL CO.
BUK-KU, DAEGU,  KS.
KYUNG GI MEDICAL INDUSTRIAL CO., LTD.
KIMPO-SI, KYUNGGI-DO,  KS.
Manufacturer;  
KYUNG GI MEDICAL INDUSTRIAL CO., LTD.
KIMPO-SI, KYUNGGI-DO,  KS.
KYUNG IL OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
KYUNG IL OPTICAL CO.
DAEGU,  KS.
KYUNG MIN TRADING CORP.
VERNON,  CA,  US.
Initial Importer;  
KYUNG MIN TRADING CORP.
VERNON,  CA ,  US.
KYUNGWON FERRITE IND. CO., LTD
SHIHEUNG-SHI, KYUNGKI-DO,  KS.
Manufacturer;  
KYUNGWON FERRITE IND. CO., LTD
SHIHEUNG-SHI, KYUNGKI-DO,  KS.
KYUSHU HITACHI MAXELL,LTD.
FUKUOKA-PREF.,  JA.
Unregistered Foreign Lister;  
KYUSHU HITACHI MAXELL,LTD.
FUKUOKA-PREF.,  JA.
L & L ENT.
CHAMPLIN,  MN,  US.
Manufacturer;  
L & L ENT.
CHAMPLIN,  MN ,  US.
L & L OPTICAL, INC.
MONTEREY PARK,  CA,  US.
Initial Importer;  
L & L OPTICAL, INC.
MONTEREY PARK,  CA ,  US.
L & L WINGS, INC.
MYRTLE BEACH,  SC,  US.
Initial Importer;  
L & L WINGS, INC.
MYRTLE BEACH,  SC ,  US.
L & M RESOURCE INFORMATION SERVICE, INC.
MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
L & M RESOURCE INFORMATION SERVICE, INC.
MIAMI,  FL ,  US.
L & N PACKAGING CORP.
FOXBORO,  MA,  US.
Initial Importer;  
L & N PACKAGING CORP.
BROCKTON,  MA ,  US.
L & S GLOBAL LLC
LOS ANGELES,  CA,  US.
Initial Importer;  
L & S GLOBAL LLC
LOS ANGELES,  CA ,  US.
L & Y INDUSTRIES CO. LTD.
SHENZHEN,  CH.
Manufacturer;  
YUE CHUEN CO., LTD.
H.K.,  HK.
L C M CO.
CHATTTANOOGA,  TN,  US.
Initial Importer;  
L C M CO.
CHATTTANOOGA,  TN ,  US.

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Last Modified: 29 April 2006
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