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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
ALVA-AMCO PHARMACAL COS., INC.
NILES,  IL,  US.
Specification Developer;  
ALVA-AMCO PHARMACAL COS., INC.
NILES,  IL ,  US.
ALVAR
NORTHBROOK,  IL,  US.
Initial Importer;  
ALVAR
NORTHBROOK,  IL ,  US.
ALVEMA AB
STOCKHOLM,  SW.
Unregistered Foreign Lister;  
ALVEMA AB
STOCKHOLM,  SW.
ALVEOLUS, INC
CHARLOTTE,  NC,  US.
Initial Importer;   Specification Developer;  
ALVEOLUS, INC
CHARLOTTE,  NC ,  US.
ALVIERO MARTINI S.P.A.
MILANO,  IT.
Foreign Exporter;  
ALVIERO MARTINI S.P.A.
MILANO,  IT.
ALWAHAB DENTAL SURGICAL CORP.
SIALKOT,  PK.
Manufacturer;  
ALWAHAB DENTAL SURGICAL CORP.
SIALKOT,  PK.
AL-WAHAB DENTAL SURGICAL CORP.
SIALKOT-1, PUNJAB,  PK.
Manufacturer;  
AL-WAHAB DENTAL SURGICAL CORP.
SIALKOT-1, PUNJAB,  PK.
ALWAYS TOP INDUSTRIES LTD.
TSUEN WAN, N.T.,  HK.
Manufacturer;  
ALWAYS TOP INDUSTRIES LTD.
TSUEN WAN, N.T.,  HK.
ALWIN ENT., INC.
SALISBURY,  MD,  US.
Specification Developer;  
ALWIN ENT., INC.
SALISBURY,  MD ,  US.
ALZA CORP.
PALO ALTO,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ALZA CORP.
PALO ALTO,  CA ,  US.
AM FAB, INC.
GALESBURG,  MI,  US.
Manufacturer;  
AM FAB INC.
GALESBURG,  MI ,  US.
AM GLOVES CO., LTD.
SHIANG TAINAN HSIEN,  TW.
Manufacturer;  
AM GLOVES CO., LTD.
SHIANG TAINAN HSIEN,  TW.
AM LABS, INC.
COLORADO SPRINGS,  CO,  US.
Initial Importer;   Specification Developer;  
AM LABS, INC.
COLORADO SPRINGS,  CO ,  US.
A-M SYSTEMS, INC.
CARLSBORG,  WA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
A-M SYSTEMS, INC.
CARLSBORG,  WA ,  US.
AM2 PAT INC.
RALEIGH,  NC,  US.
Manufacturer;  
AM2 PAT INC.
RALEIGH,  NC ,  US.
AMA OPTICS, INC.
MIAMI BEACH,  FL,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
AMA OPTICS, INC.
MIAMI BEACH,  FL ,  US.
AMADA SURGICAL, INC.
TUCSON,  AZ,  US.
Specification Developer;  
AMADA SURGICAL, INC.
TUCSON,  AZ ,  US.
AMANN OPHTHALMIC INSTRUMENTS
EM-LIPTINGEN,  GM.
Foreign Exporter;   Manufacturer;  
FRITZ EUGEN AMANN
EM-LIPTINGEN,  GM.
AMANO ENZYME U.S.A. CO., LTD.
ELGIN,  IL,  US.
Initial Importer;  
AMANO ENZYME, INC.
NAGOYA,  JA.
AMARCO MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
Repackager/Relabeller;  
AMARCO MEDIZINTECHNIK GMBH
TUTTLINGEN,  GM.
AMARDICO SRL
SAN SALVO,  IT.
Contract Manufacturer;   Manufacturer;  
AMARDICO SRL
VASTO,  IT.
A-MARK DISTRIBUTION CO. LTD.
TAIPEI,  TW.
Manufacturer;  
A-MARK DISTRIBUTION CO. LTD.
TAIPEI,  TW.
AMARSHIV OPTICAL LTD.
VADODARA, GUJARAT,  IN.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMARSHIV OPTICAL LTD.
VADODARA, GUJARAT,  IN.
A-MART CORP.
NEW YORK,  NY,  US.
Initial Importer;  
A-MART CORP.
NEW YORK,  NY ,  US.
AMBASSADOR MEDICAL INC.
CARMEL,  IN,  US.
Initial Importer;  
AMBASSADOR MEDICAL INC.
CARMEL,  IN ,  US.
AMBCO ELECTRONICS, A CALIFORNIA CORP.
TUSTIN,  CA,  US.
Manufacturer;  
AMBCO ELECTRONICS, A CALIFORNIA CORP.
TUSTIN,  CA ,  US.
AMBER CORP.
PEABODY,  MA,  US.
Initial Importer;   Specification Developer;  
AMBER CORP.
PEABODY,  MA ,  US.
AMBER DIAGNOSTICS, INC.
ORLANDO,  FL,  US.
Initial Importer;  
AMBER DIAGNOSTICS, INC.
ORLANDO,  FL ,  US.
AMBER GLOW CO., LTD.
SHINDIAN CITY, TAPEI,  TW.
Repackager/Relabeller;  
AMBER GLOW CO., LTD.
SHINDIAN CITY, TAPEI,  TW.
AMBION DIAGNOSTICS
AUSTIN,  TX,  US.
Contract Manufacturer;   Manufacturer;  
AMBION RNA DIAGNOSTICS
AUSTIN,  TX ,  US.
AMBIT CORPORATION
GAINESVILLE,  GA,  US.
Manufacturer;  
APPLIED SYSTEMS DEVELOPMENT LLC.
GAINESVILLE,  GA ,  US.
AMBITECH INTL - AXIOM OPERATIONS
BEAVERTON,  OR,  US.
Contract Manufacturer;  
AMBITECH INTL - AXIOM OPERATIONS
BEAVERTON,  OR ,  US.
AMBITION PRODUCTS DEVELOPMENT CO., LTD.
TAIPEI,  TW.
Manufacturer;  
AMBITION PRODUCTS DEVELOPMENT CO., LTD.
TAIPEI,  TW.
AMBIX LABORATORIES
TOTOWA,  NJ,  US.
Contract Manufacturer;   Manufacturer;  
ORGANICS CORPORATION OF AMERICA
TOTOWA,  NJ ,  US.
AMBLETIN LTD.
TETBURY, GLOS.,  UK.
Manufacturer;  
AMBLETIN LTD.
TETBURY, GLOS.,  UK.
AMBOW INDUSTRIAL CO.,LTD.
TAIPEI,  TW.
Repackager/Relabeller;  
AMBOW INDUSTRIAL CO.,LTD.
TAIPEI,  TW.
AMBRA LE ROY, LLC
CHARLOTTE,  NC,  US.
Initial Importer;  
AMBRA LE ROY, LLC
CHARLOTTE,  NC ,  US.
AMBRIT USA, INC.
PEMBROKE PINES,  FL,  US.
Initial Importer;  
AMBRIT USA, INC.
PEMBROKE PINES,  FL ,  US.
AMBROISE
ENSCHEDE,  NL.
Manufacturer;  
AMBROISE
ENSCHEDE,  NL.
AMBU A/S
BALLERUP,  DA.
Manufacturer;  
AMBU A/S
BALLERUP,  DA.

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Last Modified: 29 April 2006
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