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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
HYDROMAX, INC.
EMMITSBURG,  MD,  US.
Manufacturer;  
HYDROMAX, INC.
EMMITSBURG,  MD ,  US.
HYDRO-MED PRODUCTS, INC.
DALLAS,  TX,  US.
Manufacturer;  
SPECTRUM LABORATORIES, INC.
RANCHO DOMINGUEZ,  CA ,  US.
HYDRON PTY LIMITED
NEDLANDS WESTERN AUSTRALIA,  AS.
Foreign Exporter;   Manufacturer;   Specification Developer;  
HYDRON PTY LIMITED
NEDLANDS WESTERN AUSTRALIA,  AS.
HYDRON TECHNOLOGIES, INC.
POMPANO BEACH,  FL,  US.
Initial Importer;  
HYDRON TECHNOLOGIES, INC.
POMPANO BEACH,  FL ,  US.
HYDROWREST, INC.
NEEDHAM,  MA,  US.
Specification Developer;  
HYDROWREST, INC.
NEEDHAM,  MA ,  US.
HYDROX LABORATORIES, INC.
CHARLOTTE,  NC,  US.
Initial Importer;  
HYDROX LABORATORIES, INC.
CHARLOTTE,  NC ,  US.
HYE OPTIC & FASHION LAB
LOS ANGELES,  CA,  US.
Initial Importer;  
HYE OPTIC & FASHION LAB
LOS ANGELES,  CA ,  US.
HYGEIAN MEDICAL SUPPLIES (PTE) LTD.
SINGAPORE,  SN.
Specification Developer;  
HYGEIAN MEDICAL SUPPLIES (PTE) LTD.
SINGAPORE,  SN.
HYGIA HEALTH SERVICES, INC.
BIRMINGHAM,  AL,  US.
Reprocessor of single-use devices;  
HYGIA HEALTH SERVICES, INC.
BIRMINGHAM,  AL ,  US.
HYGIENE SOLUTIONS GROUP, LLC
JACKSONVILLE,  FL,  US.
Initial Importer;  
HYGIENE SOLUTIONS GROUP, LLC
JACKSONVILLE,  FL ,  US.
HYGIENEX CORP.
LAS PINAS, METRO MANILA,  RP.
Manufacturer;  
HYGIENEX CORP.
MAKATI, METRO MANILA,  RP.
HYGIENICARE, INC.
SIMSBURY,  CT,  US.
Initial Importer;  
HYGIENICARE, INC.
SIMSBURY,  CT ,  US.
HYGINET CORP. OF AMERICA
SEWICKLEY,  PA,  US.
Manufacturer;  
HYGINET CORP. OF AMERICA
SEWICKLEY,  PA ,  US.
HYGINETT HUNGARIAN AMERICAN CO. FOR THE PRODUCTION
CSOMOR,  HU.
Manufacturer;  
P&G HUNGARY KKT
BUDAPEST,  HU.
HYGO PLASTIC, INC.
GRAFTON,  WI,  US.
Manufacturer;  
HYGO PLASTIC, INC.
GRAFTON,  WI ,  US.
HYI
COVINA,  CA,  US.
Initial Importer;  
HYI
COVINA,  CA ,  US.
HYLAND DIAGNOSTICS, INC.
COLORADO SPRINGS,  CO,  US.
Specification Developer;  
HYLAND DIAGNOSTICS, INC.
COLORADO SPRINGS,  CO ,  US.
HYMANSON, INC.
MANHATTAN,  CA,  US.
Manufacturer;  
HYMANSON, INC.
MANHATTAN,  CA ,  US.
HY-MARK CYLINDERS, INC.
HAMPTON,  VA,  US.
Manufacturer;  
HY-MARK CYLINDERS, INC.
HAMPTON,  VA ,  US.
HYOSUNG (AMERICA), INC.
NEW YORK,  NY,  US.
Initial Importer;  
HYOSUNG (AMERICA), INC.
NEW YORK,  NY ,  US.
HYOSUNG CORP.
SEOUL,  KS.
Manufacturer;  
HYOSUNG CORP.
SEOUL,  KS.
HYOSUNG OPTICAL CO.
TAEGU,  KS.
Manufacturer;  
HYOSUNG OPTICAL CO.
TAEGU,  KS.
HYPERBARIC FOR LIFE LLC
PHOENIX,  AZ,  US.
Initial Importer;   Manufacturer;  
HYPERBARIC FOR LIFE LLC
PHOENIX,  AZ ,  US.
HYPERBARIC TECHNOLOGIES, INC.
AMSTERDAM,  NY,  US.
Manufacturer;  
HYPERBARIC TECHNOLOGIES, INC.
AMSTERDAM,  NY ,  US.
HYPERBARIC TECHNOLOGIES, INC.
NATIONAL CITY,  CA,  US.
Manufacturer;  
HYPERBARIC TECHNOLOGIES, INC.
NATIONAL CITY,  CA ,  US.
HYPERBARIC TECHNOLOGY BV (HYTECH)
RAAMSDONKSVEER,  NL.
Unregistered Foreign Lister;  
HYPERBARIC TECHNOLOGY BV (HYTECH)
RAAMSDONKSVEER,  NL.
HYPERSUN CO., LTD.
TAIPEI,  TW.
Manufacturer;  
HYPERSUN CO., LTD.
TAIPEI,  TW.
HYPERTEC, INC.
OLNEY,  TX,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HYPERTEC, INC.
OLNEY,  TX ,  US.
HYPERTENSION DIAGNOSTICS, INC.
EAGAN,  MN,  US.
Manufacturer;  
HYPERTENSION DIAGNOSTICS, INC.
EAGAN,  MN ,  US.
HYPHEN BIOMED
NEUVILLE SUR OISE,  FR.
Manufacturer;  
HYPHEN BIOMED
NEUVILLE SUR OISE,  FR.
HYPOGUARD USA, INC.
MINNEAPOLIS,  MN,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
MEDISYS PLC
WOODBRIDGE,  UK.
HYPOGUARD, LTD.
WOODBRIDGE,  UK.
Manufacturer;   Specification Developer;  
MEDISYS PLC
WOODBRIDGE,  UK.
HY-TAPE INTERNATIONAL, INC.
PATTERSON,  NY,  US.
Repackager/Relabeller;  
HY-TAPE INTERNATIONAL, INC.
PATTERSON,  NY ,  US.
HYTECH OPTICAL, LLC
PACIFIC PALISADES,  CA,  US.
Initial Importer;  
HYTECH OPTICAL, LLC
PACIFIC PALISADES,  CA ,  US.
HYTEL GROUP, INC.
HAMPSHIRE DRIVE,  IL,  US.
Contract Manufacturer;  
HYTEL GROUP, INC.
HAMPSHIRE DRIVE,  IL ,  US.
HY-TEN PLASTICS
MILFORD,  NH,  US.
Contract Manufacturer;  
HY-TEN PLASTICS
MILFORD,  NH ,  US.
HYUN CHANG OPTICAL CO.
DAEGU,  KS.
Unregistered Foreign Lister;  
HYUN CHANG OPTICAL CO.
DAEGU,  KS.
HYUN DAE OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
HYUN DAE OPTICAL CO.
DAEGU,  KS.
HYUNDAI CORP.
SEOUL,  KS.
Contract Manufacturer;  
HYUNDAI CORP.
SEOUL,  KS.
HYUNDAI HEALTH CARE USA
LOS ANGELES,  CA,  US.
Initial Importer;  
CS HOLDINGS, LLC
LOS ANGELES,  CA ,  US.

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Last Modified: 29 April 2006
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