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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
NISSEY VIETNAM CO., LTD.
HO CHI MINH CITY,  VM.
Manufacturer;  
NIHON SEIMITSU CO., LTD.
KAWAGUCHI, SAITAMA,  JA.
NISSIN MEDICAL INC.
TORRANCE,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
NISSIN MEDICAL INDUSTRIES CO., LTD
NISHIKASUGAI-GUN AICHI,  JA.
NISSIN MEDICAL INDUSTRIES COMPANY, LTD
AICHI-PREFECTRURE,  JA.
Manufacturer;  
NISSIN MEDICAL INDUSTRIES COMPANY, LTD
AICHI-PREFECTRURE,  JA.
NISSUI PHARMACEUTICAL CO., LTD.
YUKI, IBARAKI,  JA.
Manufacturer;  
NISSUI PHARMACEUTICAL CO., LTD.
TOKYO,  JA.
NITE TRAIN'R
BEAVERTON,  OR,  US.
Manufacturer;  
KOREGON ENTERPRISE, INC.
BEAVERTON,  OR ,  US.
NITI MEDICAL TECHNOLOGIES LTD.
NATANYA,  IS.
Manufacturer;  
NITI MEDICAL TECHNOLOGIES LTD.
NETANYA,  IS.
NITINOL DEVICES & COMPONENTS
FREMONT,  CA,  US.
Manufacturer;  
JOHNSON & JOHNSON
NEW BRUNSWICK,  NJ ,  US.
NITMIX LTD.
LOUGHBOROUGH, LEICESTERSHIRE,  UK.
Manufacturer;  
NITMIX LTD.
LOUGHBOROUGH, LEICESTERSHIRE,  UK.
NITRING ENT., INC.
NEI-HU, TAIPEI,  TW.
Manufacturer;  
NITRING ENT., INC.
NEI-HU, TAIPEI,  TW.
NITRON INDUSTRIAL, INC.
TAIPEI,  TW.
Contract Manufacturer;   Manufacturer;  
NITRON INDUSTRIAL, INC.
TAIPEI,  TW.
NITTO BOSEKI CO., LTD. (MEDICAL DIVISION)
TOKYO,  JA.
Foreign Exporter;   Manufacturer;  
NITTO BOSEKI CO., LTD. (MEDICAL DIVISION)
TOKYO,  JA.
NITTO DENKO AMERICA, INC.
FREMONT,  CA,  US.
Initial Importer;  
NITTO AMERICAS, INC.
FREMONT,  CA ,  US.
NITTO DENKO CORP.
TAMATSUKURI, MIYAGA,  JA.
Manufacturer;  
NITTO DENKO CORP.
IBARAKI CITY, OSAKA,  JA.
NIUM CORP.
SONGPA-KU, SEOUL,  KS.
Manufacturer;  
NIUM CORP.
SONGPA-KU, SEOUL,  KS.
NIVICO (PVT.), LTD.
SIALKOT,  PK.
Manufacturer;  
NIVICO (PVT.), LTD.
SIALKOT,  PK.
NIVIS, LLC
ATLANTA,  GA,  US.
Reprocessor of single-use devices;  
NIVIS, LLC
ATLANTA,  GA ,  US.
NIWKA, INC.
KYOTO,  JA.
Manufacturer;  
NIWKA, INC.
KYOTO,  JA.
NIX CO. LTD.
BUNKYO-KU, TOKYO,  JA.
Manufacturer;  
NIX CO. LTD.
BUNKYO-KU, TOKYO,  JA.
NIX OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
NIX OPTICAL CO.
DAEGU,  KS.
NIZIOL AND LYNCH, INC.
YOUNGSTOWN,  NY,  US.
Manufacturer;  
NIZIOL AND LYNCH, INC.
YOUNGSTOWN,  NY ,  US.
NJ MERCHANDISE CORP.
PASADENA,  CA,  US.
Initial Importer;  
NJ MERCHANDISE CORP.
PASADENA,  CA ,  US.
N-JECT L.P.P.
MCHENRY,  IL,  US.
Specification Developer;  
N-JECT L.P.P.
MCHENRY,  IL ,  US.
NKL CONTACTLENZEN B.V.
EMMEN,  NL.
Manufacturer;  
NKL CONTACTLENZEN B.V.
EMMEN,  NL.
NK-OPTIK AMERICA
CHICAGO,  IL,  US.
Initial Importer;  
NK-OPTIK GMBH
BAIERBRUNN,  GM.
NK-OPTIK GMBH
MUNICH D8000,  GM.
Manufacturer;  
NK-OPTIK GMBH
BAIERBRUNN,  GM.
NKUS LAB
IRVINE,  CA,  US.
Manufacturer;   Specification Developer;  
NIHON KOHDEN CORP.
TOKYO,  JA.
NMC PLASTICS LTD.
SCORBOROUGH,ONTARIO,  CA.
Manufacturer;  
NMC PLASTICS LTD.
SCORBOROUGH,ONTARIO,  CA.
NMF COMPANY
KIBUZ KFAR MASARIK, M.P.ASHRAT,  IS.
Manufacturer;  
NMF COMPANY
KIBUZ KFAR MASARIK, M.P.ASHRAT,  IS.
NMH MARKETING LLC.
LAS VEGAS,  NV,  US.
Initial Importer;  
NMH MARKETING LLC.
LAS VEGAS,  NV ,  US.
NMS INTL.
TROIS-RIVIERE, QC,  CA.
Manufacturer;  
MARIO SAUVE
ASTON-JONCTION, QC,  CA.
NMT MEDICAL, INC.
BOSTON,  MA,  US.
Manufacturer;   Specification Developer;  
NMT MEDICAL, INC.
BOSTON,  MA ,  US.
NO 7 CONTACT LENS LABORATORY LTD.
HASTINGS E. SUSSEX,  UK.
Manufacturer;  
NO 7 CONTACT LENS LABORATORY LTD.
HASTINGS E. SUSSEX,  UK.
NO BOUNDARIES MOBILITY, LLC
GARDEN GROVE,  CA,  US.
Initial Importer;  
NO BOUNDARIES MOBILITY, LLC
GARDEN GROVE,  CA ,  US.
NO GLOVE NO LOVE LTD.
MONTEGO BAY,  JM.
Foreign Exporter;  
NO GLOVE NO LOVE LTD.
MONTEGO BAY,  JM.
NO. 5 PRINTING & DYEING MILL OF SHANGHAI
SHANG HAI SHI,  CH.
Unregistered Foreign Lister;  
NO. 5 PRINTING & DYEING MILL OF SHANGHAI
SHANG HAI SHI,  CH.
NOA GRADUATE OPTICAL
PHILADELPHIA,  PA,  US.
Initial Importer;  
NOA GRADUATE OPTICAL
PHILADELPHIA,  PA ,  US.
NOA MEDICAL INDUSTRIES, INC.
WASHINGTON,  MO,  US.
Manufacturer;  
NOA MEDICAL INDUSTRIES, INC.
WASHINGTON,  MO ,  US.
NOBBY MEDICAL INSTRUMETNS (PVT) LTD.
SIALKOT, PUNJAB,  PK.
Manufacturer;  
NOBBY MEDICAL INSTRUMETNS (PVT) LTD.
SIALKOT, PUNJAB,  PK.
NOBEL BIOCARE (PRODUCTION) AB
KARLSKOGA S-691-51,  SW.
Manufacturer;   Specification Developer;  
NOBEL BIOCARE AB
GOTEBORG,  SW.
NOBEL BIOCARE AB
GOTEBORG,  SW.
Manufacturer;   Specification Developer;  
NOBEL BIOCARE AB
GOTEBORG,  SW.

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Last Modified: 29 April 2006
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