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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
NEW YORK OPTICAL INTL., INC.
SUNRISE,  FL,  US.
Initial Importer;  
NEW YORK OPTICAL INTL., INC.
SUNRISE,  FL ,  US.
NEW YORK OPTICAL WESTERN HEMISPHERE, INC.
MIRAMAR,  FL,  US.
Initial Importer;  
NEW YORK OPTICAL WESTERN HEMISPHERE, INC.
MIRAMAR,  FL ,  US.
NEW ZEALAND PHARMACEUTICALS, LIMITED
PALMERSTON NORTH,  NZ.
Unregistered Foreign Lister;  
NEW ZEALAND PHARMACEUTICALS, LIMITED
PALMERSTON NORTH,  NZ.
NEWARK GLOVE & SAFETY EQUIPMENT CO., INC.
NEWARK,  NJ,  US.
Initial Importer;  
NEWARK GLOVE & SAFETY EQUIPMENT CO., INC.
NEWARK,  NJ ,  US.
NEWAVE MEDICAL, INC.
NEW YORK,  NY,  US.
Initial Importer;  
INTERNATIONAL DENTAL RESEARCH
PARIS,  FR.
NEWBRIGHT EYEWEAR MANUFACTORY (SHENZHEN), LTD.
LONGGANG, LONGGANG,  CH.
Manufacturer;  
V & V OPTICS CO.
MA ON SHAN, SHATIN,  HK.
NEWBY-VANCE MOBILITY
GUTHRIE,  OK,  US.
Initial Importer;  
JOHN VANCE MOTORS
GUTHRIE,  OK ,  US.
NEWCARE HOME HEALTH SERVICES INC
BALTIMORE,  MD,  US.
Initial Importer;  
NEWCARE HOME HEALTH SERVICES INC
BALTIMORE,  MD ,  US.
NEWCARE PRODUCTS, LLC.
CHESHIRE,  CT,  US.
Repackager/Relabeller;  
NEWCARE PRODUCTS, LLC.
CHESHIRE,  CT ,  US.
NEWCELL-TECHNOLOGIES
MIAMI,  FL,  US.
Specification Developer;  
NEWCELL-TECHNOLOGIES
MIAMI,  FL ,  US.
NEWCO ABSORBENTS GMBH & CO. KG
BERLINGERODE,  GM.
Manufacturer;  
NEWCO ABSORBENTS GMBH & CO. KG
BERLINGERODE,  GM.
NEWDEAL S.A.
LYON,  FR.
Specification Developer;   Repackager/Relabeller;  
INTEGRA LIFESCIENCES CORPORATION
PLAINSBORO,  NJ ,  US.
NEWERA MERCHANDISE ENTERPRISE CO., LTD.
TAIPEI,  TW.
Manufacturer;  
NEWERA MERCHANDISE ENTERPRISE CO., LTD.
TAIPEI,  TW.
NEWFORD CO. LTD.
HUNGHOM, KOWLOON,  HK.
Manufacturer;  
NEWFORD CO. LTD.
HUNGHOM, KOWLOON,  HK.
NEWILL TEAM, INC.
LARGO G,  FL,  US.
Initial Importer;  
NEWILL TEAM, INC.
LARGO,  FL ,  US.
NEWKIRK INTL., INC.
NISKAYUNA,  NY,  US.
Initial Importer;  
NEWKIRK INTL., INC.
NISKAYUNA,  NY ,  US.
NEWLAND INTL., INC.
CERRITOS,  CA,  US.
Initial Importer;  
NEWLAND INTL., INC.
CERRITOS,  CA ,  US.
NEWLY RISEN INDUSTRIAL LTD.
TAIPEI,  TW.
Unregistered Foreign Lister;  
NEWLY RISEN INDUSTRIAL LTD.
TAIPEI,  TW.
NEWMAN, HOPE & CO., INC.
TAIPEI,  TW.
Repackager/Relabeller;  
NEWMAN, HOPE & CO., INC.
TAIPEI,  TW.
NEWMARK, INC.
CHESHIRE,  CT,  US.
Manufacturer;  
NEWMARK, INC.
CHESHIRE,  CT ,  US.
NEWMARKET LABORATORIES LTD.
NEWMARKET,  UK.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
NEWMARKET LABORATORIES LTD.
NEWMARKET,  UK.
NEWMEDICS SYSTEMS, INC.
SEATTLE,  WA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
NEWMEDICS SYSTEMS, INC.
SEATTLE,  WA ,  US.
NEWO PLASTICS LTD.
CHICAGO,  IL,  US.
Contract Manufacturer;   Manufacturer;  
NEWO PLASTICS LTD.
CHICAGO,  IL ,  US.
NEWPATH INTERNATIONAL INC.
WAYNE,  PA,  US.
Initial Importer;  
NEWPATH INTERNATIONAL INC.
WAYNE,  PA ,  US.
NEWPOINT MEDICAL SUPPLY, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
NEWPOINT MEDICAL SUPPLY, INC.
LOS ANGELES,  CA ,  US.
NEWPORT EYES
SAN MARCOS,  CA,  US.
Initial Importer;  
NEWPORT EYES
SAN MARCOS,  CA ,  US.
NEWPORT GOLF CORP.
ANAHEIM,  CA,  US.
Initial Importer;  
NEWPORT GOLF CORP.
ANAHEIM,  CA ,  US.
NEWPORT MEDICAL INSTRUMENTS, INC.
COSTA MESA,  CA,  US.
Initial Importer;   Manufacturer;  
NEWPORT MEDICAL INSTRUMENTS, INC.
COSTA MESA,  CA ,  US.
NEWRICH INDUSTRIAL CORP.
TAIPEI,  TW.
Unregistered Foreign Lister;  
NEWRICH INDUSTRIAL CORP.
TAIPEI,  TW.
NEWTECH INDUSTRIES CO. LTD.
TAEJEON CHOUNGNAM,  KS.
Manufacturer;  
NEWTECH INDUSTRIES CO. LTD.
TAEJEON CHOUNGNAM,  KS.
NEWTIMES WORLDWIDE, LTD.
TAIPEI,  TW.
Foreign Exporter;  
NEWTIMES WORLDWIDE, LTD.
TAIPEI,  TW.
NEWTRONIX COMMUNICATIONS, INC.
BROOKLYN,  NY,  US.
Initial Importer;  
NEWTRONIX COMMUNICATIONS, INC.
BROOKLYN,  NY ,  US.
NEWTRONIX LIMITED
YAN TIAN, FENG GANG, DONGGUAN,,  CH.
Unregistered Foreign Lister;  
NEWTRONIX LIMITED
YAN TIAN, FENG GANG, DONGGUAN,,  CH.
NEWVISION EYEWEAR INC.
DAEGU,  KS.
Manufacturer;  
NEWVISION EYEWEAR INC.
DAEGU,  KS.
NEWWAVE MEDICAL LLC
WHITEWRIGHT,  TX,  US.
Specification Developer;   Repackager/Relabeller;  
NEWWAVE MEDICAL LLC
WHITEWRIGHT,  TX ,  US.
NEXA ORTHOPEDICS, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
NEXA ORTHOPEDICS, INC.
SAN DIEGO,  CA ,  US.
NEXAIR, LLC.
MEMPHIS,  TN,  US.
Manufacturer;  
NEXAIR, LLC.
MEMPHIS,  TN ,  US.
NEXAN, INC.
ALPHARETTA,  GA,  US.
Initial Importer;  
NEXAN, INC.
ALPHARETTA,  GA ,  US.
NEXCOM PARAMETER CO., LTD.
CHONAN CITY, CHUNG-NAM,  KS.
Manufacturer;  
NEXCOM PARAMETER CO., LTD.
CHONAN CITY, CHUNG-NAM,  KS.
NEXCORE TECHNOLOGY, INC.
HACKENSACK,  NJ,  US.
Contract Manufacturer;  
NEXCORE TECHNOLOGY, INC.
HACKENSACK,  NJ ,  US.

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Last Modified: 29 April 2006
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