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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
HEALTHCARE SERVICE AND SUPPLY
MONROVIA,  CA,  US.
Specification Developer;  
HEALTHCARE SERVICE AND SUPPLY
MONROVIA,  CA ,  US.
HEALTHCARE SPECIALTIES, LLC
SAN DIEGO,  CA,  US.
Specification Developer;  
HEALTHCARE SPECIALTIES, LLC
SAN DIEGO,  CA ,  US.
HEALTHCARE TECHNOLOGY LTD.
HAMPSHIRE,  UK.
Manufacturer;   Specification Developer;  
HEALTHCARE TECHNOLOGY LTD.
HAMPSHIRE,  UK.
HEALTHCARE-ID, INC.
BUFFALO GROVE,  IL,  US.
Manufacturer;  
HEALTHCARE-ID, INC.
BUFFALO GROVE,  IL ,  US.
HEALTHCO INTERNATIONAL, LLC
DIXVILLE NOTCH,  NH,  US.
Contract Manufacturer;   Manufacturer;  
HEALTHCO INTERNATIONAL, LLC
DIXVILLE NOTCH,  NH ,  US.
HEALTHCO SURGICAL SUPPLIES
SIALKOT,  PK.
Manufacturer;  
HEALTHCO SURGICAL SUPPLIES
SIALKOT,  PK.
HEALTHCO-BREITSCHMID-CURADEN AG
KRIENS,  SZ.
Unregistered Foreign Lister;  
HEALTHCO-BREITSCHMID-CURADEN AG
KRIENS,  SZ.
HEALTHCOR OXYGEN & MEDICAL EQUIPMENT
LAWRENCE,  KS,  US.

HEALTHCOR OXYGEN & MEDICAL EQUIPMENT
DALLAS,  TX ,  US.
HEALTHCRAFT PRODUCTS, INC.
OTTAWA, ONTARIO,  CA.
Manufacturer;  
HEALTHCRAFT PRODUCTS, INC.
OTTAWA, ONTARIO,  CA.
HEALTH-DENT INT.
BATAVIA,  IL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEALTH-DENT INT.
BATAVIA,  IL ,  US.
HEALTHDENT TECHNOLOGY, LTD.
BEIJING,  CH.
Contract Manufacturer;  
HEALTHDENT TECHNOLOGY, LTD.
BEIJING,  CH.
HEALTHDRIVE AG
NEWTON,  MA,  US.
Manufacturer;  
STEVEN S. CHARLAP, M.D., P.C.
NEWTON,  MA ,  US.
HEALTHEAST MEDHOME CARE EQUIP. LTD.
ST. PAUL,  MN,  US.

HEALTHEAST, INC.
ST. PAUL,  MN ,  US.
HEALTHETECH, INC.
GOLDEN,  CO,  US.
Manufacturer;   Specification Developer;  
HEALTHETECH, INC.
GOLDEN,  CO ,  US.
HEALTHFIRST CORP.
MOUNTLAKE TERRACE,  WA,  US.
Manufacturer;  
HEALTHFIRST CORP.
MOUNTLAKE TERRACE,  WA ,  US.
HEALTHFOCUS LTD.
LONDON,  UK.
Manufacturer;  
HEALTHFOCUS LTD.
LONDON,  UK.
HEALTHHOUSE U.S.A., INC.
WESTBURY,  NY,  US.
Initial Importer;  
HEALTHHOUSE U.S.A., INC.
WESTBURY,  NY ,  US.
HEALTHLINE MEDICAL IMAGING
DAVIDSON,  NC,  US.
Manufacturer;   Specification Developer;  
HEALTHLINE MEDICAL IMAGING
DAVIDSON,  NC ,  US.
HEALTHLINK
JACKSONVILLE,  FL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEALTHLINK
JACKSONVILLE,  FL ,  US.
HEALTHMARK INDUSTRIES CO., INC.
ST. CLAIR SHORES,  MI,  US.
Specification Developer;  
HEALTHMARK INDUSTRIES CO., INC.
ST. CLAIR SHORES,  MI ,  US.
HEALTHMARK, INC.
CLACKAMAS,  OR,  US.
Manufacturer;  
HEALTHMARK, INC.
CLACKAMAS,  OR ,  US.
HEALTHMED DIST.
PORT COQUITLAM, BC,  CA.
Manufacturer;  
HEALTHMED DIST.
PORT COQUITLAM, BC,  CA.
HEALTHONICS, INC.
NEW ELLENTON,  SC,  US.
Manufacturer;   Specification Developer;  
HEALTHONICS, INC.
NEW ELLENTON,  SC ,  US.
HEALTHPAK, INC.
SHOREWOOD,  IL,  US.
Specification Developer;  
HEALTHPAK, INC.
SHOREWOOD,  IL ,  US.
HEALTH-PAK, INC.
UTICA,  NY,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
HEALTH-PAK, INC.
UTICA,  NY ,  US.
HEALTHPOINT, LTD.
FORT WORTH,  TX,  US.
Specification Developer;  
DFB PHARMACEUTICALS, INC.
SAN ANTONIO,  TX ,  US.
HEALTHPOSTURES, LLC
GLENCOE,  MN,  US.
Manufacturer;  
HEALTHPOSTURES, LLC
GLENCOE,  MN ,  US.
HEALTHPOT INDUSTRIES
SIALKOT,  PK.
Manufacturer;  
HEALTHPOT INDUSTRIES
SIALKOT,  PK.
HEALTHSOUTH CORPORATION
BIRMINGHAM,  AL,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
HEALTHSOUTH CORPORATION
BIRMINGHAM,  AL ,  US.
HEALTHTECH EXPORT ASSOCIATES, LLC
HOPKINTON,  MA,  US.
Initial Importer;  
ELLTEC CO., LTD.
NAGOYA,  JA.
HEALTHTEX DISTRIBUTORS, INC.
MIAMI,  FL,  US.
Initial Importer;  
HEALTHTEX DISTRIBUTORS, INC.
MIAMI,  FL ,  US.
HEALTHTRONICS GMBH
THURGAU,  SZ.
Manufacturer;   Specification Developer;  
HEALTHTRONICS, INC.
KENNESAW,  GA ,  US.
HEALTHWARES MANUFACTURING CORP.
CINCINNATI,  OH,  US.
Initial Importer;  
HEALTHWARES MANUFACTURING CORP.
CINCINNATI,  OH ,  US.
HEALTHWATCHSYSTEMS, INC.
ALPHARETTA,  GA,  US.
Specification Developer;  
HEALTHWATCHSYSTEMS, INC.
SARASOTA,  FL ,  US.
HEALTHWAY HOME PRODUCTS, INC.
PULASKI,  NY,  US.
Manufacturer;  
HEALTHWAY HOME PRODUCTS, INC.
PULASKI,  NY ,  US.
HEALTH-WINNER ENTERPRISE CO., LTD.
TAIPEI,  TW.
Manufacturer;  
HEALTH-WINNER ENTERPRISE CO., LTD.
TAIPEI,  TW.
HEALTHY ASSOCIATES PRODUCTS, INC.
TUSCUMBIA,  AL,  US.
Initial Importer;  
HEALTHY ASSOCIATES PRODUCTS, INC.
TUSCUMBIA,  AL ,  US.
HEALTHY BODY PRODUCTS, INC. DBA HEALTHY BODY BALL
TUCSON,  AZ,  US.
Manufacturer;  
HEALTHY BODY PRODUCTS, INC. DBA HEALTHY BODY BALL
TUCSON,  AZ ,  US.
HEALTHY DEAL.COM
NAPERVILLE,  IL,  US.
Repackager/Relabeller;  
ASHVIK INTERNATIONAL (DBA)
NAPERVILLE,  IL ,  US.
HEALTHY FUNCTIONS, LLC
SPRING LAKE,  NJ,  US.
Specification Developer;  
HEALTHY FUNCTIONS, LLC
SPRING LAKE,  NJ ,  US.

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Last Modified: 29 April 2006
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