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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
HEALTHY INFORMATION TECHNOLOGY
CAIRO,  EG.
Manufacturer;  
HEALTHY INFORMATION TECHNOLOGY
CAIRO,  EG.
HEALTHY LIFE U.S.A., INC.
SANTA MONICA,  CA,  US.
Manufacturer;  
HEALTHY LIFE U.S.A., INC.
SANTA MONICA,  CA ,  US.
HEARING AID CENTERS, INC.
INVER GROVE HEIGHTS,  MN,  US.
Manufacturer;  
HEARING AID CENTERS, INC.
INVER GROVE HEIGHTS,  MN ,  US.
HEARING AID EXPRESS
BELLAIRE,  TX,  US.
Manufacturer;  
HEARING AID EXPRESS
BELLAIRE,  TX ,  US.
HEARING AID EXPRESS
DALLAS,  TX,  US.
Manufacturer;  
HEARING AID EXPRESS
BELLAIRE,  TX ,  US.
HEARING AID FACTORY
ORANGE,  TX,  US.
Manufacturer;  
DORO LEE, INC.
ORANGE,  TX ,  US.
HEARING AIDS TODAY, INC.
MARIETTA,  GA,  US.
Manufacturer;  
HEARING AIDS TODAY, INC.
MARIETTA,  GA ,  US.
HEARING COMPONENTS, INC.
OAKDALE,  MN,  US.
Manufacturer;  
HEARING COMPONENTS, INC.
OAKDALE,  MN ,  US.
HEARING CONCEPTS INTL.
EXCELSIER,  MN,  US.
Initial Importer;   Repackager/Relabeller;  
HUBER ENT., INC.
ORONO,  MN ,  US.
HEARING CRAFTERS OF AMERICA
MT. VERNON,  MO,  US.
Manufacturer;  
HEARING CRAFTERS OF AMERICA
MT. VERNON,  MO ,  US.
HEARING HELP EXPRESS, INC.
DEKALB,  IL,  US.
Initial Importer;  
HEARING HELP EXPRESS, INC.
DEKALB,  IL ,  US.
HEARING IMPROVEMENT
OGDEN,  UT,  US.
Manufacturer;  
HEARING IMPROVEMENT
OGDEN,  UT ,  US.
HEARING TECH, INC.
TUCSON,  AZ,  US.
Manufacturer;  
HEARING TECH, INC.
TUCSON,  AZ ,  US.
HEARING TECHNOLOGIES
PINELLAS PARK,  FL,  US.
Manufacturer;  
HEARING TECHNOLOGIES
PINELLAS PARK,  FL ,  US.
HEARING TODAY LABORATORY, INC.
LENEXA,  KS,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEARING TODAY LABORATORY, INC.
LENEXA,  KS ,  US.
HEARING TODAY LABORATORY, INC.
OMAHA,  NE,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEARING TODAY LABORATORY, INC.
LENEXA,  KS ,  US.
HEARIT COMPANY, L.L.C.
ORO VALLEY,  AZ,  US.
Initial Importer;  
HEARIT COMPANY, L.L.C.
ORO VALLEY,  AZ ,  US.
HEARMORE CO., INC.
GILBERT,  AZ,  US.
Manufacturer;  
HEARMORE CO., INC.
GILBERT,  AZ ,  US.
HEARMORE CO., INC.
ST. PAUL,  MN,  US.
Contract Manufacturer;   Manufacturer;  
HEARMORE CO., INC.
ST. PAUL,  MN ,  US.
HEART IMAGING TECHNOLOGIES, LLC
DURHAM,  NC,  US.
Manufacturer;  
HEART IMAGING TECHNOLOGIES, LLC
DURHAM,  NC ,  US.
HEART RATE, INC.
COSTA MESA,  CA,  US.
Manufacturer;  
HEART RATE, INC.
COSTA MESA,  CA ,  US.
HEART WELL, INC.
TAIPEI,  TW.
Manufacturer;  
HEART WELL, INC.
TAIPEI,  TW.
HEARTBEAT MEDICAL CORP.
ALBUQUERQUE,  NM,  US.
Manufacturer;   Specification Developer;  
HEARTBEAT MEDICAL CORP.
ALBUQUERQUE,  NM ,  US.
HEARTECH LTD
RA'ANANA,  IS.
Manufacturer;  
HEARTECH LTD
RA'ANANA,  IS.
HEARTLAB, INC.
WESTERLY,  RI,  US.
Manufacturer;  
HEARTLAB, INC.
WESTERLY,  RI ,  US.
HEARTLAND MERCHANTS
KRUM,  TX,  US.
Initial Importer;   Manufacturer;  
HEARTLAND MERCHANTS
KRUM,  TX ,  US.
HEARTLAND TAN SYSTEMS
MCDONOUGH,  GA,  US.
Initial Importer;   Repackager/Relabeller;  
HEARTLAND TAN SYSTEMS
MCDONOUGH,  GA ,  US.
HEARTLAND TANNING, INC.
LEE'S SUMMIT,  MO,  US.
Manufacturer;  
HEARTLAND TANNING, INC.
LEE'S SUMMIT,  MO ,  US.
HEARTPORT, INC.
SOMERVILLE,  NJ,  US.
Specification Developer;  
HEARTPORT, INC.
SOMERVILLE,  NJ ,  US.
HEARTSCAPE TECHNOLOGIES LTD
BANGOR, CO DOWN,  UK.
Manufacturer;  
HEARTSCAPE TECHNOLOGIES INC
COLUMBIA,  MD ,  US.
HEARTSINE TECHNOLOGIES, INC.
NEWTOWN,  PA,  US.
Manufacturer;   Specification Developer;  
HEARTSINE TECHNOLOGIES, INC.
NEWTOWN,  PA ,  US.
HEARTSINE TECHNOLOGIES, LTD
BELFAST,  EI.
Foreign Exporter;   Manufacturer;   Specification Developer;  
HEARTSINE TECHNOLOGIES, INC.
NEWTOWN,  PA ,  US.
HEARTSOUNDS CORP.
DON MILLS, ONTARIO,  CA.
Manufacturer;  
HEARTSOUNDS CORP.
DON MILLS, ONTARIO,  CA.
HEARTSOUNDS, USA
WAYZATA,  MN,  US.
Initial Importer;  
HEARTSOUNDS CORP.
DON MILLS, ONTARIO,  CA.
HEARTWARE, INC.
DURHAM,  NC,  US.
Manufacturer;  
HEARTWARE, INC.
DURHAM,  NC ,  US.
HEARTWAY MEDICAL PRODUCTS CO., LTD.
TAICHUNG,  TW.
Manufacturer;  
HEARTWAY MEDICAL PRODUCTS CO., LTD.
TAICHUNG,  TW.
HEAT SHIELD, INC.
EASTCHESTER,  NY,  US.
Initial Importer;  
HEAT SHIELD, INC.
EASTCHESTER,  NY ,  US.
HEAT WHEAT PRODUCTS AMERICA, INC
MINNEAPOLIS,  MN,  US.
Initial Importer;  
HEAT WHEAT INTERNATIONAL PTY LTD
BURLEIGH HEADS, QUEENSLAND,  AS.
HEATHER MEDICAL DISTRIBUTOR LLC
CRANSTON,  RI,  US.
Initial Importer;  
HEATHER MEDICAL DISTRIBUTOR LLC
CRANSTON,  RI ,  US.
HEATMAX, INC.
DALTON,  GA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HEATMAX, INC.
DALTON,  GA ,  US.

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Last Modified: 29 April 2006
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