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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
HURRICANE HARDWARE, INC.
HSIN TIEN CITY, TAIPEI HSIEN,  TW.
Manufacturer;  
HURRICANE HARDWARE, INC.
HSIN TIEN CITY, TAIPEI HSIEN,  TW.
HURRICANE MEDICAL
BRADENTON,  FL,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
HURRICANE MEDICAL
BRADENTON,  FL ,  US.
HUTCHINSON TECHNOLOGY, INC.
HUTCHINSON,  MN,  US.
Manufacturer;  
HUTCHINSON TECHNOLOGY, INC.
HUTCHINSON,  MN ,  US.
HUTCHISON INTL., INC.
BATON ROUGE,  LA,  US.
Initial Importer;  
HUTCHISON INTL., INC.
BATON ROUGE,  LA ,  US.
HU-TECH, INC.
SABAE CITY, FUKUI PREFECTURE,  JA.
Manufacturer;  
HU-TECH, INC.
SABAE CITY, FUKUI PREFECTURE,  JA.
HUVITZ CO., LTD.
GYEONGGI-DO,  KS.
Manufacturer;  
HUVITZ CO., LTD.
GYEONGGI-DO,  KS.
HUZHOU SHENGLI INDUSTRY MANUFACTURING CO., LTD.
HUZHOU, ZHEJIANG PROVINCE,  CH.
Contract Manufacturer;   Manufacturer;  
HUZHOU SHENGLI INDUSTRY MANUFACTURING CO., LTD.
HUZHOU, ZHEJIANG PROVINCE,  CH.
HW & B ASSEMBLY WERKS, INC.
ALGONQUIN,  IL,  US.
Contract Manufacturer;  
HW & B ASSEMBLY WERKS, INC.
ALGONQUIN,  IL ,  US.
HWA MAO OPTICAL CO., LTD.
XIAMEN,  CH.
Manufacturer;  
HWA MAO OPTICAL CO., LTD.
XIAMEN,  CH.
HWA MEEI OPTICAL CO., LTD.
TAINAN,  TW.
Manufacturer;  
HWA MEEI OPTICAL CO., LTD.
TAINAN,  TW.
HWA NAN PLASTICS MFG. IND. LTD.
TAIPEI HSIEN,  TW.
Contract Manufacturer;  
HWA NAN PLASTICS MFG. IND. LTD.
TAIPEI HSIEN,  TW.
HWA SHUN RUBBER ENT. CO. LTD.
TAICHUNG HSIEN,  TW.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HWA SHUN RUBBER ENT. CO. LTD.
TAICHUNG HSIEN,  TW.
HWA SUNG CORP.
IN CHEON,  KS.
Unregistered Foreign Lister;  
HWA SUNG CORP.
IN CHEON,  KS.
HWA SUNG GENERAL INTERNATIONAL OPTICAL CO.
TAEGU,  KS.
Unregistered Foreign Lister;  
HWA SUNG GENERAL INTERNATIONAL OPTICAL CO.
TAEGU,  KS.
HWA SUNG OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
HWA SUNG OPTICAL CO.
DAEGU,  KS.
HWA TEH INDUSTRIAL SDN. BHD.
BATANG BERJUNTAI,  MY.
Manufacturer;  
HWA TEH INDUSTRIAL SDN. BHD.
BATANG BERJUNTAI,  MY.
HWA UEI ENTERPRISE CO.
TAINAN,  TW.
Manufacturer;  
HWA UEI ENTERPRISE CO.
TAINAN,  TW.
HWADONG CO., LTD.
SEOUL,  KS.
Unregistered Foreign Lister;  
HWADONG CO., LTD.
SEOUL,  KS.
HWAN YIN ENTERPRISE CO., LTD.
TAIWAN R.O.C.,  TW.
Manufacturer;  
HWAN YIN ENTERPRISE CO., LTD.
TAIWAN R.O.C.,  TW.
HWANG DA SUNGLASSES CO., LTD
YUNG KANG CITY, TAINAN,  TW.
Manufacturer;   Specification Developer;  
HWANG DA SUNGLASSES CO., LTD
YUNG KANG CITY, TAINAN,  TW.
HWEI MAI CO.,LTD.
TAIPEI,  TW.
Unregistered Foreign Lister;  
HWEI MAI CO.,LTD.
TAIPEI,  TW.
HY LABORATORIES, LTD.
REHOVOT,  IS.
Manufacturer;  
HY LABORATORIES, LTD.
REHOVOT,  IS.
HYALURON, INC.
BURLINGTON,  MA,  US.
Contract Manufacturer;  
HYALURON, INC.
BURLINGTON,  MA ,  US.
HYCARE INTL. CO., LTD.
HATYAI, SONGKHLA,  TH.
Foreign Exporter;   Manufacturer;   Specification Developer;  
HYCARE INTL. CO., LTD.
HATYAI, SONGKHLA,  TH.
HYCEL DIAGNOSTICS
POUILLY EN AUXOIS,  FR.
Manufacturer;  
HYCEL DIAGNOSTICS
POUILLY EN AUXOIS,  FR.
HYCLONE AKTIEBOLAG
TAURANGA,  NZ.
Contract Manufacturer;   Manufacturer;  
HYCLONE AKTIEBOLAG
TAURANGA,  NZ.
HYCLONE LABORATORIES, INC.
LOGAN,  UT,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
HYCLONE LABORATORIES, INC.
LOGAN,  UT ,  US.
HYCOR BIOMEDICAL LTD.
EDINBURGH,  UK.
Manufacturer;  
HYCOR BIOMEDICAL LTD.
EDINBURGH,  UK.
HYCOR BIOMEDICAL, INC.
GARDEN GROVE,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HYCOR BIOMEDICAL, INC.
GARDEN GROVE,  CA ,  US.
HYDAS FABRIK FUR MEDIZINAL-BEDARF GMBH & CO.
HIRZENHAINER STRASSE,  GM.
Unregistered Foreign Lister;  
HYDAS FABRIK FUR MEDIZINAL-BEDARF GMBH & CO.
HIRZENHAINER STRASSE,  GM.
HYDRO MED, INC.
SHERMAN OAKS,  CA,  US.
Initial Importer;  
MURRAY GROSSAN, M.D.
SHERMAN OAKS,  CA ,  US.
HYDRO SYSTEMS, INC.
SANTA FE,  NM,  US.
Manufacturer;  
HYDRO SYSTEMS, INC.
SANTA FE,  NM ,  US.
HYDROCISION, INC.
BILLERICA,  MA,  US.
Manufacturer;  
HYDROCISION, INC.
BILLERICA,  MA ,  US.
HYDROCO (AUSTRALIA) PTY. LTD.
SEAFORD VICTORIA,  AS.
Manufacturer;  
HYDROCO (AUSTRALIA) PTY. LTD.
SEAFORD VICTORIA,  AS.
HYDROFERA, LLC.
WILLIMANTIC,  CT,  US.
Contract Manufacturer;   Manufacturer;  
HYDROFERA, LLC.
WILLIMANTIC,  CT ,  US.
HYDROGEL DESIGN SYSTEMS, INC.
LANGHORNE,  PA,  US.
Manufacturer;  
HYDROGEL DESIGN SYSTEMS, INC.
LANGHORNE,  PA ,  US.
HYDROGEL VISION CORPORATION
SARASOTA,  FL,  US.
Manufacturer;  
HYDROGEL VISION CORPORATION
SARASOTA,  FL ,  US.
HYDROGEL VISION CORPORATION
SARASOTA,  FL,  US.
Manufacturer;  
HYDROGEL VISION CORPORATION
SARASOTA,  FL ,  US.
HYDROGEL VISION CORPORATION
SARASOTA,  FL,  US.
Manufacturer;  
HYDROGEL VISION CORPORATION
SARASOTA,  FL ,  US.
HYDROL CHEMICAL CO.
YEADON,  PA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HYDROL CHEMICAL CO.
YEADON,  PA ,  US.

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Last Modified: 29 April 2006
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