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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
HOSPITAL SERVICE DIVISION
BEULAH,  MI,  US.
Repackager/Relabeller;  
AURIC ENT., INC.
BEULAH,  MI ,  US.
HOSPITAL SPECIALTY CO.
CLEVELAND,  OH,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HOSPITAL SPECIALTY CO.
HIGHLAND HEIGHTS,  OH ,  US.
HOSPITAL SPECIALTY CO.
NICHOLASVILLE,  KY,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HOSPITAL SPECIALTY CO.
HIGHLAND HEIGHTS,  OH ,  US.
HOSPITAL SPECIALTY CO.
TEMPE,  AZ,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HOSPITAL SPECIALTY CO.
HIGHLAND HEIGHTS,  OH ,  US.
HOSPITAL THERAPY PRODUCTS, INC.
WOOD DALE,  IL,  US.
Manufacturer;  
HOSPITAL THERAPY PRODUCTS, INC.
PALATINE,  IL ,  US.
HOSPITEC, INC.
WEST PALM BEACH,  FL,  US.
Initial Importer;  
HOSPITEC, INC.
CALGARY, ALBERTA,  CA.
HOSPITECH MANUFACTURING SERVICES SDN. BHD.
KLANG SELANGOR,  MY.
Unregistered Foreign Lister;  
HOSPITECH MANUFACTURING SERVICES SDN. BHD.
KLANG SELANGOR,  MY.
HOSSAIN DYEING & PRINTING MILLS LTD.
DHAKA,  BG.
Manufacturer;  
HOSSAIN DYEING & PRINTING MILLS LTD.
DHAKA,  BG.
HOST INTERNATIONAL INC.
SEATTLE,  WA,  US.
Initial Importer;  
HOST INTERNATIONAL INC.
BETHESDA,  MD ,  US.
HOSUK AMERICA
AURORA,  CO,  US.
Initial Importer;  
HOSUK CO., LTD.
CHUNGCHEONG,  KS.
HOT HEADZ OF AMERICAN
PHILADELPHIA,  PA,  US.
Initial Importer;  
HOT HEADZ OF AMERICAN
PHILADELPHIA,  PA ,  US.
HOT ROD CONDOMS
BURBANK,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
HOT ROD CONDOMS
BURBANK,  CA ,  US.
HOTEL AMENITIES INTERNATIONAL LIMITED
FANLING, N.T.,  HK.
Unregistered Foreign Lister;  
HOTEL AMENITIES INTERNATIONAL LIMITED
FANLING, N.T.,  HK.
HOTEL AMENITIES INTERNATIONAL LTD., USA
FT. LAUDERDALE,  FL,  US.
Initial Importer;  
HOTEL AMENITIES INTERNATIONAL LTD., USA
FT. LAUDERDALE,  FL ,  US.
HOTELPLUS AMENITIES MANUFACTURING COMPANY LIMITED
TOWN, DONGGUAN, GUANGDONG,  CH.
Manufacturer;  
HOTELPLUS AMENITIES MANUFACTURING COMPANY LIMITED
KOWLOON BAY, KOWLOON,  HK.
HOTRON ENTERPRISE CO.
SOUTH EL MONTE,  CA,  US.
Initial Importer;  
HOTRON ENTERPRISE CO.
SOUTH EL MONTE,  CA ,  US.
HOU GINE OPTICAL MFY. CO.
KWUN TONG, KOWLOON,  HK.
Manufacturer;  
HOU GINE OPTICAL MFY. CO.
KWUN TONG, KOWLOON,  HK.
HOUCK MACHINE CO.
PLYMOUTH,  MN,  US.
Contract Manufacturer;  
HOUCK MACHINE CO.
MINNEAPOLIS,  MN ,  US.
HOUSE OF HEARING
MESA,  AZ,  US.
Remanufacturer;  
HOUSE OF HEARING
MESA,  AZ ,  US.
HOUSE OF SOON
HONOLULU,  HI,  US.
Initial Importer;  
HOUSE OF SOON
HONOLULU,  HI ,  US.
HOUSE OF SURGICAL (PVT) LTD.
SIALKOT 4, PUNJAB,  PK.
Manufacturer;  
HOUSE OF SURGICAL (PVT) LTD.
SIALKOT 4, PUNJAB,  PK.
HOUSE OF SURGICAL SUPPLIES, INC.
DEER PARK,  NY,  US.
Initial Importer;  
HOUSE OF SURGICAL SUPPLIES, INC.
DEER PARK,  NY ,  US.
HOUSECALL MEDICAL EQUIPMENT, INC.
RIVIERA BEACH,  FL,  US.

HOUSE CALL HOME MEDICAL EQUIP., INC.
KNOXVILLE,  TN ,  US.
HOUSTON HARDWARE & PLASTIC (SHENZHEN) CO., LTD.
SHENZHEN,  CH.
Manufacturer;  
ORIENTAL METALWARE MFY. LTD.
LAM TEI,  HK.
HOUSTON OPTICAL CO., LTD.
SAN PO KONG, KOWLOON,  HK.
Unregistered Foreign Lister;  
HOUSTON OPTICAL CO., LTD.
SAN PO KONG, KOWLOON,  HK.
HOUSTON PLASTIC PRODUCTS
HOUSTON,  TX,  US.
Contract Manufacturer;  
FRED ALLEN CO., INC.
HOUSTON,  TX ,  US.
HOVEROUND CORP.
SARASOTA,  FL,  US.
Initial Importer;   Manufacturer;  
HOVEROUND CORP.
SARASOTA,  FL ,  US.
HO-WANG ENT. CO. LTD.
TAOYUAN,  TW.
Manufacturer;  
HO-WANG ENT. CO. LTD.
TAOYUAN,  TW.
HOWARD DISTRIBUTORS, INC.
NEW YORK,  NY,  US.
Initial Importer;  
HOWARD DISTRIBUTORS, INC.
NEW YORK,  NY ,  US.
HOWARD INSTRUMENTS, INC.
TUSCALOOSA,  AL,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
HOWARD INSTRUMENTS, INC.
TUSCALOOSA,  AL ,  US.
HOWARD KAISER
NEW HYDE PARK,  NY,  US.
Initial Importer;  
HOWARD KAISER
NEW HYDE PARK,  NY ,  US.
HOWARD MEDICAL CO.
CHICAGO,  IL,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
HOWARD MEDICAL CO.
CHICAGO,  IL ,  US.
HOWARD MEDICAL CO.
MONMOUTH,  IL,  US.
Manufacturer;  
HOWARD MEDICAL CO.
CHICAGO,  IL ,  US.
HOWARD WRIGHT LIMITED
NEW PLYMOUTH,  NZ.
Foreign Exporter;   Manufacturer;  
HOWARD WRIGHT LIMITED
NEW PLYMOUTH,  NZ.
HOWELL VENTURES LTD.
UPPER KINGSCLEAR, NB,  CA.
Manufacturer;  
HOWELL VENTURES LTD.
UPPER KINGSCLEAR, NB,  CA.
HOWELL-ROGERS INTERNATIONAL, INC.
SARASOTA,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
HOWELL-ROGERS INTERNATIONAL, INC.
SARASOTA,  FL ,  US.
HOWER TOOL
OSSIAN,  IN,  US.
Contract Manufacturer;  
AKRON EQUIPMENT CO.
AKRON,  OH ,  US.
HOWMEDICA INTERNATIONAL S. DE R.L.,
LIMERICK,  EI.
Manufacturer;  
STRYKER CORP.
KALAMAZOO,  MI ,  US.
HOWMEDICA MOUNTAIN STATES, INC.
SALT LAKE CITY,  UT,  US.

HOWMEDICA MOUNTAIN STATES, INC.
SALT LAKE CITY,  UT ,  US.
HOWMEDICA OSTEONICS CORP
MAHWAH,  NJ,  US.
Initial Importer;   Manufacturer;  
STRYKER CORP.
KALAMAZOO,  MI ,  US.

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Last Modified: 29 April 2006
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