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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
HEALTH CHECK PRODUCTS, INC.
RIVERSIDE,  CA,  US.
Repackager/Relabeller;  
HEALTH CHECK PRODUCTS, INC.
RIVERSIDE,  CA ,  US.
HEALTH CHEM DIAGNOSTICS LLC
POMPANO BEACH,  FL,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEALTH CHEM DIAGNOSTICS LLC
POMPANO BEACH,  FL ,  US.
HEALTH DIRECTIONS, INC.
LEVITTOWN,  PA,  US.
Specification Developer;  
HEALTH DIRECTIONS, INC.
LEVITTOWN,  PA ,  US.
HEALTH EDUCATION FOR LIFE
ST. PAUL,  MN,  US.
Specification Developer;  
HEALTH EDUCATION FOR LIFE
ST. PAUL,  MN ,  US.
HEALTH ENT., INC.
NORTH ATTLEBORO,  MA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HEALTH ENT., INC.
NORTH ATTLEBORO,  MA ,  US.
HEALTH EQUIPMENT MANUFACTURERS, INC.
FREMONT,  IN,  US.
Manufacturer;  
HEALTH EQUIPMENT MANUFACTURERS, INC.
FREMONT,  IN ,  US.
HEALTH FIRST
SAN FRANCISCO,  CA,  US.
Initial Importer;  
HEALTH FIRST
SAN FRANCISCO,  CA ,  US.
HEALTH FOCUS (CALIFORNIA) INC.
ANAHEIM,  CA,  US.
Initial Importer;  
OSIM INTERNATIONAL LTD.
SINGAPORE,  SN.
HEALTH GUARD PRODUCTS
ANAHEIM,  CA,  US.
Initial Importer;  
HEALTH GUARD PRODUCTS
ANAHEIM,  CA ,  US.
HEALTH HERO NETWORK, INC.
REDWOOD CITY,  CA,  US.
Manufacturer;   Specification Developer;  
HEALTH HERO NETWORK, INC.
REDWOOD CITY,  CA ,  US.
HEALTH HORIZON INTL., INC.
LACHUTE, QUEBEC,  CA.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEALTH HORIZON INTL., INC.
LACHUTE, QUEBEC,  CA.
HEALTH IMPROVEMENT ASSOC.
FREELAND,  MI,  US.
Specification Developer;   Repackager/Relabeller;  
HEALTH IMPROVEMENT ASSOC.
FREELAND,  MI ,  US.
HEALTH INFORMATICS TECHNOLOGIES, L.L.C.
ALLENDALE,  NJ,  US.
Specification Developer;  
DYNAMIC IMAGING, LLC
ALLENDALE,  NJ ,  US.
HEALTH INSYNCS LLC
RICHMOND,  VA,  US.
Initial Importer;  
HEALTH INSYNCS LLC
RICHMOND,  VA ,  US.
HEALTH KEEPER 9000 USA INC.
LOS ANGELES,  CA,  US.
Manufacturer;  
HEALTH KEEPER 9000 USA INC.
LOS ANGELES,  CA ,  US.
HEALTH MARK, INC.
KEARNY,  NJ,  US.
Initial Importer;  
HEALTH MARK, INC.
KEARNY,  NJ ,  US.
HEALTH MONITORING SERVICES, INC.
BOCA RATON,  FL,  US.
Initial Importer;  
HEALTH MONITORING SERVICES, INC.
BOCA RATON,  FL ,  US.
HEALTH MOVE, LLC.
DAVIE,  FL,  US.
Initial Importer;  
HEALTH MOVE, LLC.
DAVIE,  FL ,  US.
HEALTH QUIP, INC.
ATLANTA,  GA,  US.
Initial Importer;  
HEALTH QUIP, INC.
ATLANTA,  GA ,  US.
HEALTH RELATED PRODUCTS
GREENWOOD,  SC,  US.
Manufacturer;  
HEALTH RELATED PRODUCTS
GREENWOOD,  SC ,  US.
HEALTH SCIENCE PRODUCTS, INC.
BIRMINGHAM,  AL,  US.
Manufacturer;  
HEALTH SCIENCE PRODUCTS, INC.
BIRMINGHAM,  AL ,  US.
HEALTH SCIENCE PRODUCTS, LLC
PHOENIX,  AZ,  US.
Manufacturer;   Remanufacturer;  
HEALTH SCIENCE PRODUCTS, LLC
PHOENIX,  AZ ,  US.
HEALTH SEARCH, INC.
KINGS PARK,  NY,  US.
Initial Importer;  
HEALTH SEARCH, INC.
KINGS PARK,  NY ,  US.
HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP.
LOS ANGELES,  CA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP.
LOS ANGELES,  CA ,  US.
HEALTH SONICS CORP.
LIVERMORE,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEALTH SONICS CORP.
LIVERMORE,  CA ,  US.
HEALTH SOURCE ONE
NASHVILLE,  TN,  US.
Initial Importer;   Repackager/Relabeller;  
HEALTH SOURCE ONE
NASHVILLE,  TN ,  US.
HEALTH SOURCE SOLUTIONS, LLC
HILLIARD,  OH,  US.
Initial Importer;  
HEALTH SOURCE SOLUTIONS, LLC
HILLIARD,  OH ,  US.
HEALTH TECH
TOTOWA,  NJ,  US.
Contract Manufacturer;   Repackager/Relabeller;  
HEALTH TECH
TOTOWA,  NJ ,  US.
HEALTH TECHNICS, INC.
NORTH AURORA,  IL,  US.
Initial Importer;  
HEALTH TECHNICS, INC.
AURORA,  IL ,  US.
HEALTH TECHNOLOGIES PTY LTD.
MAYVILLE DURBAN,  SF.
Unregistered Foreign Lister;  
HEALTH TECHNOLOGIES PTY LTD.
MAYVILLE DURBAN,  SF.
HEALTH TECHNOLOGY LTD.
SCOTTSDALE,  AZ,  US.
Initial Importer;  
HEALTH TECHNOLOGY LTD.
SCOTTSDALE,  AZ ,  US.
HEALTH TRONICS, INC.
KENNESAW,  GA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
HEALTHTRONICS, INC.
KENNESAW,  GA ,  US.
HEALTH WATCH PERSONAL RESPONSE SYSTEMS
BOCA RATON,  FL,  US.
Manufacturer;  
HEALTH WATCH PERSONAL RESPONSE SYSTEMS
BOCA RATON,  FL ,  US.
HEALTH, SAFETY & ENVIRONMENTAL SOLUTIONS, INC.
WINNIPEG, MANITOBA,  CA.
Specification Developer;  
HEALTH, SAFETY & ENVIRONMENTAL SOLUTIONS, INC.
WINNIPEG, MANITOBA,  CA.
HEALTHCARE ENTERPRISE GROUP, INC.
EL SEGUNDO,  CA,  US.
Initial Importer;   Specification Developer;  
HEALTHCARE ENTERPRISE GROUP, INC.
EL SEGUNDO,  CA ,  US.
HEALTHCARE EQUIPMENT SPECIALTY
WICHITA FALLS,  TX,  US.
Initial Importer;  
HEALTHCARE EQUIPMENT SPECIALTY
WICHITA FALLS,  TX ,  US.
HEALTHCARE GLOVES SDN BHD
BATU CAVES SELANGOR,  MY.
Contract Manufacturer;   Manufacturer;  
HEALTHCARE GLOVES SDN BHD
BATU CAVES SELANGOR,  MY.
HEALTHCARE MANAGEMENT SYSTEMS, INC.
NASHVILLE,  TN,  US.
Manufacturer;  
HEALTHCARE MANAGEMENT SYSTEMS, INC.
NASHVILLE,  TN ,  US.
HEALTHCARE PRODUCTS PLUS, INC.
NASHVILLE,  TN,  US.
Initial Importer;   Specification Developer;  
HEALTHCARE PRODUCTS PLUS, INC.
NASHVILLE,  TN ,  US.
HEALTHCARE PRODUCTS, INC.
ARLINGTON HEIGHTS,  IL,  US.
Initial Importer;  
HEALTHCARE PRODUCTS, INC.
ARLINGTON HEIGHTS,  IL ,  US.

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Last Modified: 29 April 2006
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