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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
AMERICAN HEALTHCARE INC.
NEW YORK,  NY,  US.
Initial Importer;   Specification Developer;  
AMERICAN HEALTHCARE INC.
NEW YORK,  NY ,  US.
AMERICAN HEALTHCARE PRODUCTS, INC.
ALHAMBRA,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
AMERICAN HEALTHCARE PRODUCTS, INC.
ALHAMBRA,  CA ,  US.
AMERICAN HEALTHCARE SUPPLY CO., INC.
CHARLOTTE,  NC,  US.
Initial Importer;  
AMERICAN HEALTHCARE SUPPLY CO., INC.
CHARLOTTE,  NC ,  US.
AMERICAN HEARING LABORATORY
CARROLLTON,  TX,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMERICAN HEARING LABORATORY
CARROLLTON,  TX ,  US.
AMERICAN HEARING SYSTEMS INC.
PLYMOUTH,  MN,  US.
Manufacturer;  
INTERTON HOERGERAETE GMBH
BERGISCH GLADBACH,  GM.
AMERICAN HOMEPATIENT
WATERLOO,  IA,  US.

AMERICAN HOMEPATIENT
WATERLOO,  IA ,  US.
AMERICAN HOSPITAL PRODUCTS
RANCHO CUCAMONGA,  CA,  US.
Repackager/Relabeller;  
AMERICAN HOSPITAL PRODUCTS
RANCHO CUCAMONGA,  CA ,  US.
AMERICAN HOTEL REGISTER CO.
VERNON HILLS,  IL,  US.
Initial Importer;  
AMERICAN HOTEL REGISTER CO.
VERNON HILLS,  IL ,  US.
AMERICAN I.V. PRODUCTS, INC.
HANOVER,  MD,  US.
Manufacturer;  
AMERICAN I.V. PRODUCTS, INC.
HANOVER,  MD ,  US.
AMERICAN IMEX
IRVINE,  CA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
AMERICAN IMEX
IRVINE,  CA ,  US.
AMERICAN IMMUNO TECH
TUSTIN,  CA,  US.
Specification Developer;  
AMERICAN IMMUNO TECH
TUSTIN,  CA ,  US.
AMERICAN INNOTEK, INC.
ESCONDIDO,  CA,  US.
Manufacturer;  
AMERICAN INNOTEK, INC.
ESCONDIDO,  CA ,  US.
AMERICAN INSTITUTE OF KORYO HAND THERAPY
LOS ANGELES,  CA,  US.
Initial Importer;  
AMERICAN INSTITUTE OF KORYO HAND THERAPY
LOS ANGELES,  CA ,  US.
AMERICAN INSTRUMENT MANUFACTURERS
LABADIE,  MO,  US.
Initial Importer;   Manufacturer;  
AMERICAN INSTRUMENT MANUFACTURERS
LABADIE,  MO ,  US.
AMERICAN INTERNATIONAL TRADE
SAN DIEGO,  CA,  US.
Initial Importer;  
AMERICAN INTERNATIONAL TRADE
SAN DIEGO,  CA ,  US.
AMERICAN INTL. MEDICINE, INC.
IRVINE,  CA,  US.
Initial Importer;  
AMERICAN INTL. MEDICINE, INC.
IRVINE,  CA ,  US.
AMERICAN JD GROUP
LOMBARD,  IL,  US.
Initial Importer;  
AMERICAN JD GROUP
LOMBARD,  IL ,  US.
AMERICAN JIA LI TRADING CO.
RICHMOND HILL,  NY,  US.
Initial Importer;  
AMERICAN JIA LI TRADING CO.
RICHMOND HILL,  NY ,  US.
AMERICAN LABOR
DURHAM,  NC,  US.
Initial Importer;  
AMERICAN LABOR
DURHAM,  NC ,  US.
AMERICAN LABORATORY PRODUCTS CO., LTD.
SALEM,  NH,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
AMERICAN LABORATORY PRODUCTS CO., LTD.
WINDHAM,  NH ,  US.
AMERICAN LABORATORY SUPPLY LLC
BRADENTON,  FL,  US.
Initial Importer;  
AMERICAN LABORATORY SUPPLY LLC
BRADENTON,  FL ,  US.
AMERICAN LAUBSCHER CORPORATION
FARMINGDALE,  NY,  US.
Initial Importer;  
AMERICAN LAUBSCHER HOLDINGS
FARMINGDALE,  NY ,  US.
AMERICAN LENS CO.
CHICAGO,  IL,  US.
Initial Importer;  
AMERICAN LENS CO.
CHICAGO,  IL ,  US.
AMERICAN LIGHTING
RIVERSIDE,  CA,  US.
Initial Importer;  
AMERICAN LIGHTING
RIVERSIDE,  CA ,  US.
AMERICAN MAMMOGRAPHICS, INC.
CHATTANOOGA,  TN,  US.
Manufacturer;   Specification Developer;  
AMERICAN MAMMOGRAPHICS, INC.
CHATTANOOGA,  TN ,  US.
AMERICAN MANUFACTURING TECHNOLOGIES, INC.
AVONDALE,  PA,  US.
Contract Manufacturer;  
AMERICAN MANUFACTURING TECHNOLOGIES, INC.
AVONDALE,  PA ,  US.
AMERICAN MARKETING INC.
WOODLAND HILLS,  CA,  US.
Initial Importer;  
AMERICAN MARKETING INC.
WOODLAND HILLS,  CA ,  US.
AMERICAN MASSAGE PRODUCTS, INC.
SILVER CREEK,  NY,  US.
Manufacturer;  
AMERICAN MASSAGE PRODUCTS, INC.
SILVER CREEK,  NY ,  US.
AMERICAN MASTER GROUP
MONTEREY PARK,  CA,  US.
Initial Importer;  
AMERICAN MASTER GROUP
MONTEREY PARK,  CA ,  US.
AMERICAN MASTERTECH SCIENTIFIC, INC.
LODI,  CA,  US.
Manufacturer;  
AMERICAN MASTERTECH SCIENTIFIC, INC.
LODI,  CA ,  US.
AMERICAN MEDICAL
LONGVIEW,  WA,  US.

CARE MEDICAL EQUIPMENT, INC.
PORTLAND,  OR ,  US.
AMERICAN MEDICAL
VANCOUVER,  WA,  US.

CARE MEDICAL EQUIPMENT, INC.
PORTLAND,  OR ,  US.
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
VALENCIA,  CA,  US.
Initial Importer;  
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
VALENCIA,  CA ,  US.
AMERICAN MEDICAL & SCIENTIFIC INSTRUMENTS, INC.
STATEN ISLAND,  NY,  US.
Initial Importer;  
AMERICAN MEDICAL & SCIENTIFIC INSTRUMENTS, INC.
STATEN ISLAND,  NY ,  US.
AMERICAN MEDICAL ALERT CORP.
MOUNT LAUREL,  NJ,  US.
Manufacturer;  
AMERICAN MEDICAL ALERT CORP.
OCEANSIDE,  NY ,  US.
AMERICAN MEDICAL ASSEMBLY & PACKAGING L.L.C.
KENILWORTH,  NJ,  US.
Contract Manufacturer;  
AMERICAN MEDICAL ASSEMBLY & PACKAGING L.L.C.
KENILWORTH,  NJ ,  US.
AMERICAN MEDICAL BIOCARE INC.
NEWPORT BEACH,  CA,  US.
Initial Importer;   Manufacturer;  
AMERICAN MEDICAL BIOCARE INC.
NEWPORT BEACH,  CA ,  US.
AMERICAN MEDICAL DEVELOPMENT, INC.
LOWELL,  MA,  US.

AMERICAN MEDICAL DEVELOPMENT, INC.
LOWELL,  MA ,  US.
AMERICAN MEDICAL DEVICES, INC.
ATLANTA,  GA,  US.
Specification Developer;  
AMERICAN MEDICAL DEVICES, INC.
NORTH ATLANTA,  GA ,  US.
AMERICAN MEDICAL DEVICES, INC.
SAN BERNARDINO,  CA,  US.
Manufacturer;  
AMERICAN MEDICAL DEVICES, INC.
SAN BERNARDINO,  CA ,  US.

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Last Modified: 29 April 2006
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