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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
A-TRACK INTERNATIONAL
MONGKOK, KOWLOON,  HK.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
A-TRACK INTERNATIONAL
MONGKOK, KOWLOON,  HK.
ATRIA GENETICS, INC.
SOUTH SAN FRANCISCO,  CA,  US.
Manufacturer;  
ATRIA GENETICS, INC.
SOUTH SAN FRANCISCO,  CA ,  US.
ATRICURE INC.
WEST CHESTER,  OH,  US.
Manufacturer;  
ATRICURE, INC.
WEST CHESTER,  OH ,  US.
ATRICURE, INC.
WEST CHESTER,  OH,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ATRICURE, INC.
WEST CHESTER,  OH ,  US.
ATRION MEDICAL PRODUCTS, INC.
ARAB,  AL,  US.
Contract Manufacturer;   Manufacturer;  
ATRION CORP.
ALLEN,  TX ,  US.
ATRIUM BUYING CORP.
JOHNSTOWN,  OH,  US.
Initial Importer;  
ATRIUM BUYING CORP.
JOHNSTOWN,  OH ,  US.
ATRIUM MEDICAL CORP.
HUDSON,  NH,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ATRIUM MEDICAL CORP.
HUDSON,  NH ,  US.
ATS LABORATORIES, INC.
BRIDGEPORT,  CT,  US.
Manufacturer;  
ATS LABORATORIES, INC.
BRIDGEPORT,  CT ,  US.
ATS MEDICAL, INC.
MINNEAPOLIS,  MN,  US.
Manufacturer;   Specification Developer;  
ATS MEDICAL, INC.
MINNEAPOLIS,  MN ,  US.
ATTACHMENTS INTL., INC.
SAN MATEO,  CA,  US.
Specification Developer;   Repackager/Relabeller;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
ATTAIN CO., LTD.
HONOLULU,  HI,  US.
Initial Importer;  
ATTAIN CO., LTD.
HONOLULU,  HI ,  US.
ATTENDO SYSTEMS GROUP AB
STOCKHOLM,  SW.
Foreign Exporter;   Specification Developer;  
ATTENDO SYSTEMS GROUP AB
STOCKHOLM,  SW.
ATTO TECH CO., LTD.
NAMGU INCHEON-CITY,  KS.
Manufacturer;  
ATTO TECH CO., LTD.
NAMGU INCHEON-CITY,  KS.
ATTOSTAR LLC
ST. PAUL,  MN,  US.
Manufacturer;  
ATTOSTAR LLC
EDINA,  MN ,  US.
ATV SOLUTIONS, INC.
ARVADA,  CO,  US.
Initial Importer;  
ATV SOLUTIONS, INC.
ARVADA,  CO ,  US.
ATWOOD INDUSTRIES
CARDIFF-BY-THE-SEA,  CA,  US.
Specification Developer;  
ATWOOD INDUSTRIES
CARDIFF-BY-THE-SEA,  CA ,  US.
AT-WORLD REHABILITATION REVOLUTION, LTD.
HOLON,  IS.
Manufacturer;  
AT-WORLD REHABILITATION REVOLUTION, LTD.
HOLON,  IS.
AU COURANT OPTICIANS
BAL HARBOUR,  FL,  US.
Initial Importer;  
AU COURANT OPTICIANS
ANN ARBOR,  MI ,  US.
AU&U LLC
SALT LAKE CITY,  UT,  US.
Initial Importer;  
AU&U LLC
SALT LAKE CITY,  UT ,  US.
AUBER S.R.L.
SAONARA - PD,  IT.
Contract Manufacturer;   Manufacturer;  
AUBER S.R.L.
SAONARA - PD,  IT.
AUBERT & DUVAL TECHPY
IMPHY,  FR.
Manufacturer;  
AUBERT & DUVAL HOLDING
CLERMONT-FERRAND,  FR.
AUBERT AND DUVAL USA INC
PARSIPPANY,  NJ,  US.
Initial Importer;  
AUBERT AND DUVAL USA INC
PARSIPPANY,  NJ ,  US.
AUBREY GROUP
IRVINE,  CA,  US.
Contract Manufacturer;  
AUBREY GROUP
IRVINE,  CA ,  US.
AUDIA (BEIJING) TECHNOLOGY
BEIJING,  CH.
Foreign Exporter;   Manufacturer;  
AUDIA (BEIJING) TECHNOLOGY
BEIJING,  CH.
AUDIFONOS AUDIO CENTRO, INC.
SAN JUAN,  PR,  US.
Initial Importer;  
AUDIFONOS AUDIO CENTRO, INC.
SAN JUAN,  PR ,  US.
AUDIFON-USA INC.
DEBARY,  FL,  US.
Manufacturer;  
AUDIFON - GMBH
KOLLEDA, THURINGIA,  GM.
AUDINA HEARING INSTRUMENT
LONGWOOD,  FL,  US.
Initial Importer;   Manufacturer;  
AUDINA HEARING INSTRUMENT
LONGWOOD,  FL ,  US.
AUDIO "D"
WINDHAM,  ME,  US.
Manufacturer;  
HEARING SOLUTIONS, INC.
WINDHAM,  ME ,  US.
AUDIO CONTROLE, INC.
SHERBROOKE, QUEBEC,  CA.
Manufacturer;  
AUDIO CONTROLE, INC.
SHERBROOKE, QUEBEC,  CA.
AUDIO HEARING AID SERVICE
NEW PHILADELPHIA,  OH,  US.
Manufacturer;  
AUDIO HEARING AID SERVICE
NEW PHILADELPHIA,  OH ,  US.
AUDIO MEDICAL DEVICES LTD.
BECKENHAM, KENT,  UK.
Manufacturer;  
AUDIO MEDICAL DEVICES LTD.
BECKENHAM, KENT,  UK.
AUDIO TECHNOLOGIES S.R.L.
PIACENZA,  IT.
Manufacturer;  
AUDIO TECHNOLOGIES S.R.L.
PIACENZA,  IT.
AUDIOLOGICAL ENGINEERING CORP.
SOMERVILLE,  MA,  US.
Manufacturer;  
AUDIOLOGICAL ENGINEERING CORP.
SOMERVILLE,  MA ,  US.
AUDIOLOGY & HEARING AID SERVICES
KUTZTOWN,  PA,  US.

AUDIOLOGY & HEARING AID SERVICES
KUTZTOWN,  PA ,  US.
AUDIOLOGY ASSOC. OF AMERICA
ALTAMONTE SPRINGS,  FL,  US.
Initial Importer;   Manufacturer;  
AUDIOLOGY ASSOC. OF AMERICA
ALTAMONTE SPRINGS,  FL ,  US.
AUDIOLOGY LABORATORY
CASTRO VALLEY,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AUDIOLOGY LABORATORY
CASTRO VALLEY,  CA ,  US.
AUDIOLOGY, HEARING AIDS & EYE WEAR CENTER
ROCHESTER,  NH,  US.
Manufacturer;  
AUDIOLOGY, HEARING AIDS & EYE WEAR CENTER
ROCHESTER,  NH ,  US.
AUDIOMEDTRIC TECHNOLOGY, INC.
BUFFALO,  NY,  US.
Initial Importer;  
AUDIOMEDTRIC TECHNOLOGY, INC.
BUFFALO,  NY ,  US.
AUDIO-TECH LABS
SURPRISE,  AZ,  US.

AUDIO-TECH LABS
SURPRISE,  AZ ,  US.
AUDIPHONE HEARING INSTRUMENTS
METAIRIE,  LA,  US.
Initial Importer;  
AUDIPHONE HEARING INSTRUMENTS
METAIRIE,  LA ,  US.

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Last Modified: 29 April 2006
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