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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
ASCHER HEALTH CARE
FEASTERVILLE,  PA,  US.
Initial Importer;  
ASCHER HEALTH CARE
FEASTERVILLE,  PA ,  US.
ASCLEPION LASER TECHNOLOGIES GMBH
JENA,  GM.
Manufacturer;  
ASCLEPION LASER TECHNOLOGIES GMBH
JENA,  GM.
ASCLEPIUS CORP.
ARCADIA,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
ASCLEPIUS CORP.
ARCADIA,  CA ,  US.
ASCO TREATMENTS LLC
CHESTER,  NJ,  US.
Initial Importer;  
ASCO TREATMENTS LLC
CHESTER,  NJ ,  US.
ASCOT PACIFIC LTD.
CENTRAL,  HK.
Unregistered Foreign Lister;  
ASCOT PACIFIC LTD.
CENTRAL,  HK.
ASE INTERNATIONAL, LLC
MEMPHIS,  TN,  US.
Repackager/Relabeller;  
ASE INTERNATIONAL, LLC
MEMPHIS,  TN ,  US.
ASELLA, INC.
CLEARWATER,  FL,  US.
Contract Manufacturer;  
ASELLA, INC.
CLEARWATER,  FL ,  US.
ASEMTEC, INC.
SAN JOSE,  CA,  US.
Contract Manufacturer;  
ASEMTEC, INC.
SAN JOSE,  CA ,  US.
ASEPTEX MEDICAL PRODUCTS
BRICK,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
ASEPTEX MEDICAL PRODUCTS
BRICK,  NJ ,  US.
ASEPTICO, INC.
WOODINVILLE,  WA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ASEPTICO, INC.
WOODINVILLE,  WA ,  US.
ASH INSTRUMENTS
PLYMOUTH, DEVON,  UK.
Manufacturer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
ASH INSTRUMENTS, INC.
PHILADELPHIA,  PA,  US.
Repackager/Relabeller;  
ASH INSTRUMENTS, INC.
PHILADELPHIA,  PA ,  US.
ASHAWAY LINE & TWINE MFG. CO.
ASHAWAY,  RI,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ASHAWAY LINE & TWINE MFG. CO.
ASHAWAY,  RI ,  US.
ASHER-ANDELL LTD.
LEICESTERSHIRE,  UK.
Manufacturer;  
ASHER-ANDELL LTD.
LEICESTERSHIRE,  UK.
ASHITAKA FACTORY OF TERUMO CORP.
FUJINOMIYA, SHIZUOKA,  JA.
Manufacturer;  
TERUMO CORP.
SHIBUYA-KU, TOKYO,  JA.
ASHRAF SURGICAL WORKS (REGD)
SIALKOT PUNJAB,  PK.
Manufacturer;  
ASHRAF SURGICAL WORKS (REGD)
SIALKOT PUNJAB,  PK.
ASHTON OPTICAL IMPORTS, INC.
ALISO VIEJO,  CA,  US.
Initial Importer;  
OPTICAL SHOP OF ASPEN
ALISO VIEJO,  CA ,  US.
ASHTON PUMPMATIC, INC.
DAYTON,  OH,  US.
Manufacturer;  
ASHTON PUMPMATIC, INC.
DAYTON,  OH ,  US.
ASHTON SAFETY
ROCHESTER,  NY,  US.
Initial Importer;  
ASHTON SAFETY
ROCHESTER,  NY ,  US.
ASH-USA
YORK,  PA,  US.

DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
ASHWOOD INC.
HIALEAH,  FL,  US.
Initial Importer;  
ASHWOOD INC.
HIALEAH,  FL ,  US.
ASI ADVANCED SURGICAL INSTRUMENTATION, LLC.
ROWLETT,  TX,  US.
Initial Importer;  
ASI ADVANCED SURGICAL INSTRUMENTATION, LLC.
ROWLETT,  TX ,  US.
ASI MEDICAL, INC.
ENGLEWOOD,  CO,  US.
Manufacturer;  
ASI MEDICAL, INC.
ENGLEWOOD,  CO ,  US.
ASIA ACCESS, LLC.
BREMERTON,  WA,  US.
Initial Importer;  
ASIA ACCESS, LLC.
BREMERTON,  WA ,  US.
ASIA CENTER ENTERPRISE CO.
HONOLULU,  HI,  US.
Initial Importer;  
ASIA CENTER ENTERPRISE CO.
HONOLULU,  HI ,  US.
ASIA DYNAMICS, INC.
WAUKEGAN,  IL,  US.
Initial Importer;  
ASIA DYNAMICS, INC.
WAUKEGAN,  IL ,  US.
ASIA MARKETING CO.
FLUSHING,  NY,  US.
Initial Importer;  
ASIA MARKETING CO.
FLUSHING,  NY ,  US.
ASIA OPTICAL MANUFACTORY, LTD.
LONG GANG QU, SHENZHEN,  CH.
Unregistered Foreign Lister;  
ASIA OPTICAL MANUFACTORY, LTD.
LONG GANG QU, SHENZHEN,  CH.
ASIA OPTICAL MANUFACTORY, LTD.
HUNG HOM, KOWLOON,  HK.
Manufacturer;  
ASIA OPTICAL MANUFACTORY, LTD.
HUNG HOM, KOWLOON,  HK.
ASIA OPTICAL MFY.
SHENZHEN,  CH.
Manufacturer;  
ASIA OPTICAL MANUFACTORY, LTD.
HUNG HOM, KOWLOON,  HK.
ASIA PACIFIC EXPORT LTD.
ALLENTOWN,  PA,  US.
Initial Importer;  
ASIA PACIFIC EXPORT LTD.
ALLENTOWN,  PA ,  US.
ASIA PACIFIC LATEX SDN BHD
IPOH PERAK,  MY.
Manufacturer;  
ASIA PACIFIC LATEX SDN BHD
IPOH,  MY.
ASIA PACIFIC MICROSYSTEMS, INC.
HSIN CHU,  TW.
Manufacturer;  
ASIA PACIFIC MICROSYSTEMS, INC.
HSIN CHU,  TW.
ASIA PACIFIC PARTNERS CORP
NINGBO, ZHEJIANG,  CH.
Foreign Exporter;   Specification Developer;  
ASIA PACIFIC PARTNERS CORP
NINGBO, ZHEJIANG,  CH.
ASIA PACIFIC TRADING CO., INC.
NORTH POINT,  HK.
Manufacturer;  
ASIA PACIFIC TRADING CO., INC.
NORTH POINT,  HK.
ASIA PACIFIC TRADING CO., INC.
VERNON,  CA,  US.
Initial Importer;  
ASIA PACIFIC TRADING CO., INC.
VERNON,  CA ,  US.
ASIA PLASTIC TOYS FTY. LTD.
KOWLOON,  HK.
Unregistered Foreign Lister;  
ASIA PLASTIC TOYS FTY. LTD.
KOWLOON,  HK.
ASIA TREASURE OPTICAL CO., LTD.
TAINAN,  TW.
Manufacturer;  
ASIA TREASURE OPTICAL CO., LTD.
TAINAN,  TW.
ASIA-MED GMBH AND CO KG
SUHL,  GM.
Manufacturer;   Specification Developer;  
ASIA-MED GMBH AND CO KG
SUHL,  GM.
ASIAMED PROFESSIONAL L.P.
BOSTON,  MA,  US.
Initial Importer;   Repackager/Relabeller;  
AM HOLDINGS LLC
WILMINGTON,  DE ,  US.

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Last Modified: 29 April 2006
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