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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
NICO S.R.L.
TORINO,  IT.
Manufacturer;  
NICO S.R.L.
TORINO,  IT.
NICOLAY GMBH & CO. KG
NAGOLD,  GM.
Manufacturer;  
NICOLAY GMBH & CO. KG
NAGOLD,  GM.
NICOMO AB
MALMO,  SW.
Specification Developer;  
NICOMO AB
MALMO,  SW.
NIDACON INTERNATIONAL AB
MOLNDAL,  SW.
Manufacturer;  
NIDACON INTERNATIONAL AB
MOLNDAL,  SW.
NIDACON LABORATORIES AB
GOTEBORG,  SW.
Unregistered Foreign Lister;  
NIDACON LABORATORIES AB
GOTEBORG,  SW.
NIDEK CO., LTD.
GAMAGORI, AICHI,  JA.
Manufacturer;  
NIDEK CO., LTD.
GAMAGORI, AICHI,  JA.
NIDEK CO., LTD. HAMACHO PLANT
GAMAGORI, AICHI,  JA.
Manufacturer;  
NIDEK CO., LTD.
GAMAGORI, AICHI,  JA.
NIDEK MEDICAL PRODUCTS, INC.
BIRMINGHAM,  AL,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
NIDEK MEDICAL PRODUCTS, INC.
BIRMINGHAM,  AL ,  US.
NIDEK TECHNOLOGIES AMERICA, INC.
GREENSBORO,  NC,  US.
Initial Importer;  
NIDEK CO., LTD.
GAMAGORI, AICHI,  JA.
NIDEK TECHNOLOGIES SRL
ALBIGNASEGO (PADOVA),  IT.
Manufacturer;  
NIDEK TECHNOLOGIES SRL
ALBIGNASEGO (PADOVA),  IT.
NIDEK, INC.
FREMONT,  CA,  US.
Initial Importer;   Manufacturer;  
NIDEK CO., LTD.
GAMAGORI, AICHI,  JA.
NIDOR PTY LTD
CLIFTON HILL, VICTORIA,  AS.
Manufacturer;  
NIDOR PTY LTD
CLIFTON HILL, VICTORIA,  AS.
NIGHTHAWK MFG, INC.
EDMONTON, ALBERTA,  CA.
Manufacturer;  
NIGHTHAWK MFG, INC.
EDMONTON, ALBERTA,  CA.
NIGURA OPTIK GMBH
DUSSELDORF,  GM.
Manufacturer;  
MOULIN GLOBAL EYECARE TRADING LIMITED
KOWLOON BAY, KOWLOON,  HK.
NIHON CHUSHASHIN KOGYO CO. LTD.
TOKYO,  JA.
Manufacturer;  
NIHON CHUSHASHIN KOGYO CO. LTD.
TOKYO,  JA.
NIHON COMAC CO. LTD.
MATSUMOTO,  JA.
Manufacturer;  
NIHON COMAC CO. LTD.
MATSUMOTO,  JA.
NIHON DENSHI KOGYO CO., LTD.
TOYOTA, AICHI,  JA.
Manufacturer;  
NIHON DENSHI KOGYO CO., LTD.
TOYOTA, AICHI,  JA.
NIHON KOHDEN AMERICA, INC.
FOOTHILL RANCH,  CA,  US.
Initial Importer;  
NIHON KOHDEN CORP.
TOKYO,  JA.
NIHON KOHDEN CORP.
TOKYO,  JA.
Manufacturer;  
NIHON KOHDEN CORP.
TOKYO,  JA.
NIHON KOHDEN TOMIOKA CORP.
TOMIOKA CITY, GUNMA,  JA.
Manufacturer;  
NIHON KOHDEN CORP.
TOKYO,  JA.
NIHON MEDICAL INSTRUMENTS CO.,LTD.
BUNKYO-KU,TOKYO,  JA.
Unregistered Foreign Lister;  
NIHON MEDICAL INSTRUMENTS CO.,LTD.
BUNKYO-KU,TOKYO,  JA.
NIHON MEDIX CO., LTD.
MATSUDO CHIBA,  JA.
Manufacturer;  
NIHON MEDIX CO., LTD.
MATSUDO CHIBA,  JA.
NIHON MILLIPORE LTD.
TOKYO,  JA.
Foreign Exporter;   Specification Developer;  
MILLIPORE CORP.
BILLERICA,  MA ,  US.
NIHON SEIMITSU SOKKI CO., LTD.
GUNMA-KEN,  JA.
Foreign Exporter;   Manufacturer;  
NIHON SEIMITSU SOKKI CO., LTD.
GUNMA-KEN,  JA.
NIKE, INC.
BEAVERTON,  OR,  US.
Initial Importer;   Specification Developer;  
NIKE, INC.
BEAVERTON,  OR ,  US.
NIKKEN INCORPORATED
IRVINE,  CA,  US.
Initial Importer;  
NIKKEN INCORPORATED
IRVINE,  CA ,  US.
NIKKI OPTICAL
TOYONAKA CITY, OSAKA,  JA.
Foreign Exporter;   Manufacturer;  
NIKKI OPTICAL
TOYONAKA CITY, OSAKA,  JA.
NIKKISO CO., LTD. - SHIZUOKA PLANT
SHIZUOKA-KEN,  JA.
Manufacturer;  
NIKKISO CO. LTD.
TOKYO,  JA.
NIKO MEDICAL PRODUCTS
STONEHOUSE, GLOUCHESTER,  UK.
Manufacturer;  
UNOMEDICAL A/S
BIRKEROD,  DA.
NIKO-DOME OPTIK CO., LTD.
DAEGU,  KS.
Unregistered Foreign Lister;  
NIKO-DOME OPTIK CO., LTD.
DAEGU,  KS.
NIKOLAUS STRAUB CHIRURGISCHE INSTRUMENTE
RENQUISHAUSEN,  GM.
Manufacturer;  
NIKOLAUS STRAUB CHIRURGISCHE INSTRUMENTE
RENQUISHAUSEN,  GM.
NIKOMED U.S.A., INC.
DOYLESTOWN,  PA,  US.
Initial Importer;   Repackager/Relabeller;  
NIKOMED U.S.A., INC.
DOYLESTOWN,  PA ,  US.
NIKON CORPORATION
CHIYODA-KU, TOKYO,  JA.
Manufacturer;  
NIKON CORPORATION
CHIYODA-KU, TOKYO,  JA.
NIKON EYEWEAR CO., LTD.
SUMIDA-KU, TOKYO,  JA.
Manufacturer;  
NIKON EYEWEAR CO., LTD.
SUMIDA-KU, TOKYO,  JA.
NIKON INC.
MELVILLE,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
NIKON INC.
MELVILLE,  NY ,  US.
NIKON OPTICAL USA, INC
NORTHVALE,  NJ,  US.
Initial Importer;  
ESSILOR INTERNATIONAL, S.A.
CHARENTON, CEDEX,  FR.
NIKON-ESSILOR CO., LTD.
NASU-GUN, TOCHIGI-KEN,  JA.
Manufacturer;  
ESSILOR INTERNATIONAL, S.A.
CHARENTON, CEDEX,  FR.
NILNAV PTY. LTD.
BROOKVALE, NEW SOUTH WALES,  AS.
Manufacturer;  
NILNAV PTY. LTD.
BROOKVALE, NEW SOUTH WALES,  AS.
NIM, INC.
PHILADELPHIA,  PA,  US.
Manufacturer;   Specification Developer;  
NIM, INC.
PHILADELPHIA,  PA ,  US.
NIMAR
SAN MARINO,  SM.
Unregistered Foreign Lister;  
NIMAR
SAN MARINO,  SM.

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Last Modified: 29 April 2006
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