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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
NEUROTHERM LTD.
CROYDON, SURREY,  UK.
Foreign Exporter;   Specification Developer;  
RDG MEDICAL HOLDINGS LTD.
MANCHESTER,  UK.
NEUROTHERM, INC.
MIDDLETON,  MA,  US.
Initial Importer;   Specification Developer;  
RF MEDICAL HOLDINGS INC.
NEW YORK,  NY ,  US.
NEUROTONE SYSTEMS, INC.
GARLAND,  TX,  US.
Initial Importer;   Manufacturer;  
NEUROTONE SYSTEMS, INC.
GARLAND,  TX ,  US.
NEUROTRON MEDICAL
EWING,  NJ,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
NEUROTRON MEDICAL
EWING,  NJ ,  US.
NEUROTRON, INC.
BALTIMORE,  MD,  US.
Specification Developer;   Repackager/Relabeller;  
NEUROTRON, INC.
BALTIMORE,  MD ,  US.
NEUROTRONICS, INC.
GAINESVILLE,  FL,  US.
Manufacturer;  
NEUROTRONICS, INC.
GAINESVILLE,  FL ,  US.
NEUROVISION MEDICAL PRODUCTS, INC.
VENTURA,  CA,  US.
Repackager/Relabeller;  
NEUROVISION MEDICAL PRODUCTS, INC.
VENTURA,  CA ,  US.
NEUROVISION, INC.
SINGAPORE,  SN.
Manufacturer;  
NEUROVISION, INC.
SINGAPORE,  SN.
NEUSOFT MEDICAL SYSTEMS CO., LTD.
SHENYANG, LIAONING,  CH.
Foreign Exporter;  
NEUSOFT MEDICAL SYSTEMS CO., LTD.
SHENYANG, LIAONING,  CH.
NEU-TOOL DESIGN INC.
WILMINGTON,  MA,  US.
Contract Manufacturer;  
NEU-TOOL DESIGN INC.
WILMINGTON,  MA ,  US.
NEUTRAL POSTURE, INC.
BRYAN,  TX,  US.
Manufacturer;  
NEUTRAL POSTURE, INC.
BRYAN,  TX ,  US.
NEUTRON PRODUCTS, INC.
DICKERSON,  MD,  US.
Manufacturer;   Contract Sterilizer;  
NEUTRON PRODUCTS, INC.
DICKERSON,  MD ,  US.
NEUTRON PRODUCTS, INC.
RANSON,  WV,  US.
Remanufacturer;  
NEUTRON PRODUCTS, INC.
DICKERSON,  MD ,  US.
NEVIN LABORATORIES, INC.
CHICAGO,  IL,  US.
Repackager/Relabeller;  
NEVIN LABORATORIES, INC.
CHICAGO,  IL ,  US.
NEV-TECH, INC.
SOUTHERN PINES,  NC,  US.
Initial Importer;  
NEV-TECH, INC.
SOUTHERN PINES,  NC ,  US.
NEW ALLIANCE OF INDEPENDENT MEDICAL DISTRIBUTORS,
AUSTIN,  TX,  US.
Specification Developer;  
NEW ALLIANCE OF INDEPENDENT MEDICAL DISTRIBUTORS,
AUSTIN,  TX ,  US.
NEW BAY INTERNATIONAL INC.
CENTEREACH,  NY,  US.
Initial Importer;  
NEW BAY INTERNATIONAL INC.
CENTEREACH,  NY ,  US.
NEW BIO CO. LTD.
GWANGJU,  KS.
Manufacturer;  
NEW BIO CO. LTD.
GWANGJU,  KS.
NEW BRIGHT HANDBAG FACTORY, LTD.
KOWLOON BAY, HONG KONG,  CH.
Repackager/Relabeller;  
NEW BRIGHT HANDBAG FACTORY, LTD.
KOWLOON BAY, HONG KONG,  CH.
NEW BUSINESS DEVELOPMENT, LLC
WOODSTOCK,  GA,  US.
Contract Manufacturer;   Manufacturer;  
NEW BUSINESS DEVELOPMENT, LLC
WOODSTOCK,  GA ,  US.
NEW CAPITAL TRADE CO., LTD.
INCHON,  KS.
Manufacturer;  
NEW CAPITAL TRADE CO., LTD.
INCHON,  KS.
NEW CAST INDUSTRY AMERICA, LLC.
RENO,  NV,  US.
Initial Importer;  
NEW CAST INDUSTRY AMERICA, LLC.
RENO,  NV ,  US.
NEW CAST INDUSTRY CO. LTD.
ULSAN METROPOLITAN CITY,  KS.
Manufacturer;  
NEW CAST INDUSTRY CO. LTD.
ULSAN METROPOLITAN CITY,  KS.
NEW CASTEN SURGICAL CO.
SIALKOT,  PK.
Manufacturer;  
NEW CASTEN SURGICAL CO.
SIALKOT,  PK.
NEW CENTURY DENTAL HANDPIECE, INC.
MONROE,  GA,  US.
Specification Developer;  
NEW CENTURY DENTAL HANDPIECE, INC.
MONROE,  GA ,  US.
NEW CENTURY MFG. ENT. LTD.
KWUN TONG,  HK.
Unregistered Foreign Lister;  
NEW CENTURY MFG. ENT. LTD.
KWUN TONG,  HK.
NEW CHEMIC (U.S.), INC.
MONTVALE,  NJ,  US.
Initial Importer;  
NEW CHEMIC LTD.
KOWLOON,  HK.
NEW CLASSIC, INC.
LONG ISLAND CITY,  NY,  US.
Initial Importer;  
NEW CLASSIC, INC.
LONG ISLAND CITY,  NY ,  US.
NEW CONCEPT, S.A./KORLOFF
GRIMBERGEN,  BE.
Unregistered Foreign Lister;  
NEW CONCEPT, S.A./KORLOFF
GRIMBERGEN,  BE.
NEW CREATION TECHNOLOGY LTD.
KWAI CHUNG, NT,  HK.
Foreign Exporter;  
QUEST PRODUCTS, INC
LIBERTYVILLE,  IL ,  US.
NEW CREATION, INC. (U.S.A.)
EL SEGUNDO,  CA,  US.
Initial Importer;  
NEW CREATION, INC. (U.S.A.)
EL SEGUNDO,  CA ,  US.
NEW DALEY INTL. TRADING CO.
ELMHURST,  NY,  US.
Initial Importer;  
NEW DALEY INTL. TRADING CO.
ELMHURST,  NY ,  US.
NEW DAWN DISTRIBUTION INC.
GIRARD,  OH,  US.
Initial Importer;  
NEW DAWN DISTRIBUTION INC.
GIRARD,  OH ,  US.
NEW DAY INC.
OREM,  UT,  US.
Initial Importer;   Specification Developer;  
NEW DAY INC.
OREM,  UT ,  US.
NEW DAY TRADING CORP.
MIDDLETOWN,  NJ,  US.
Initial Importer;  
NEW DAY TRADING CORP.
MIDDLETOWN,  NJ ,  US.
NEW DEANTRONICS TAIWAN, LTD.
HSIN TIEN CITY,  TW.
Manufacturer;   Specification Developer;  
NEW DEANTRONICS TAIWAN, LTD.
HSIN TIEN CITY,  TW.
NEW DEANTRONICS, LTD.
WALNUT CREEK,  CA,  US.
Initial Importer;   Specification Developer;  
NEW DEANTRONICS, LTD.
WALNUT CREEK,  CA ,  US.
NEW EASY COMPANY SRL
BARCO DI BIBBIANO, (RE),  IT.
Foreign Exporter;   Manufacturer;  
NEW EASY COMPANY SRL
BARCO DI BIBBIANO, (RE),  IT.
NEW ENGLAND CASTINGS, LLC
HIRAM,  ME,  US.
Contract Manufacturer;  
NEW ENGLAND CASTINGS, LLC
HIRAM,  ME ,  US.
NEW ENGLAND IMPORT CO.
FRAMINGHAM,  MA,  US.
Initial Importer;  
NEW ENGLAND IMPORT CO.
FRAMINGHAM,  MA ,  US.

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Last Modified: 29 April 2006
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