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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
HI-SHINBEE KOREA CO., LTD.
SEOUL,  KS.
Manufacturer;  
HI-SHINBEE KOREA CO., LTD.
SEOUL,  KS.
HI-SHINE ENT. CO., LTD.
TAINAN HSIEN,  TW.
Manufacturer;  
HI-SHINE ENT. CO., LTD.
TAINAN HSIEN,  TW.
HI-SOLAR INTL. ENT., INC.
EL CERRITO,  CA,  US.
Initial Importer;  
HI-SOLAR INTL. ENT., INC.
EL CERRITO,  CA ,  US.
HISTO S.A.
BUENOS AIRES,  AR.
Manufacturer;  
HISTO S.A.
BUENOS AIRES,  AR.
HISTOIRE DE VOIR
PARIS,  FR.
Manufacturer;  
HISTOIRE DE VOIR
PARIS,  FR.
HIT PROMOTIONAL PRODUCTS, INC.
LARGO,  FL,  US.
Initial Importer;  
HIT PROMOTIONAL PRODUCTS, INC.
LARGO,  FL ,  US.
HIT, INC.
NIAGARA FALLS,  NY,  US.
Initial Importer;  
ADVANCED DENTAL CO.OF CANADA LTD.
NIAGARA FALLS, ONTARIO,  CA.
HITACHI AMERICA, LTD.,POWER AND INDUSTRIAL DIVISIO
HOUSTON,  TX,  US.
Initial Importer;   Manufacturer;  
HITACHI AMERICA, LTD.,POWER AND INDUSTRIAL DIVISIO
HOUSTON,  TX ,  US.
HITACHI CHEMICAL DIAGNOSTICS, INC.
MOUNTAIN VIEW,  CA,  US.
Manufacturer;  
HITACHI CHEMICAL DIAGNOSTICS, INC.
MOUNTAIN VIEW,  CA ,  US.
HITACHI COMPUTER PRODUCTS (AMERICA), INC., ELEC. M
NORMAN,  OK,  US.
Contract Manufacturer;  
HITACHI COMPUTER PRODUCTS (AMERICA), INC., ELEC. M
NORMAN,  OK ,  US.
HITACHI HIGH-TECHNOLOGIES CORP.
HITACHINAKA, IBARAKI,  JA.
Manufacturer;  
HITACHI HIGH-TECHNOLOGIES CORP.
MINATO-KU,  JA.
HITACHI MEDICAL CORP.
TOKYO,  JA.
Manufacturer;  
HITACHI MEDICAL CORP.
TOKYO,  JA.
HITACHI MEDICAL SYSTEMS AMERICA, INC.
TWINSBURG,  OH,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
HITACHI MEDICAL SYSTEMS AMERICA, INC.
TWINSBURG,  OH ,  US.
HITACHI SCIENCE SYSTEMS, LTD.
HITACHINAKA-SHI,  JA.
Manufacturer;  
HITACHI HIGH-TECHNOLOGIES CORP.
MINATO-KU,  JA.
HITACHI, LTD., POWER SYSTEMS
TOKYO,  JA.
Foreign Exporter;   Manufacturer;  
HITACHI, LTD., POWER SYSTEMS
TOKYO,  JA.
HI-TECH MOULDED PRODUCTS LTD.
REXDALE, ONTARIO,  CA.
Manufacturer;  
STEELWOOD INV.
WESTON, ONTARIO,  CA.
HI-TECH OPTICAL CO.
SABAE CITY, FUKUI,  JA.
Manufacturer;  
HI-TECH OPTICAL CO.
FUKUI CITY,  JA.
HI-TECH PHARMA INC.
PORT MOODY, B.C.,  CA.
Remanufacturer;   Repackager/Relabeller;  
HI-TECH PHARMA INC.
PORT MOODY, B.C.,  CA.
HI-TECH PLASTICS, INC.
CAMBRIDGE,  MD,  US.
Manufacturer;  
HI-TECH PLASTICS, INC.
CAMBRIDGE,  MD ,  US.
HI-TECH PRODUCTS
BUENA PARK,  CA,  US.
Contract Manufacturer;  
HI-TECH PRODUCTS
BUENA PARK,  CA ,  US.
HI-TECH RUBBER, INC.
ANAHEIM,  CA,  US.
Contract Manufacturer;  
HI-TECH RUBBER, INC.
ANAHEIM,  CA ,  US.
HI-TECH SWISS MACHINING, INC.
VISTA,  CA,  US.
Contract Manufacturer;  
HI-TECH SWISS MACHINING, INC.
VISTA,  CA ,  US.
HITECHOLDINGS CO., LTD
PUCHUN-CITY, KYUNGGI-DO,  KS.
Manufacturer;  
HITECHOLDINGS CO., LTD
PUCHUN-CITY, KYUNGGI-DO,  KS.
HITEK CONCEPTS, INC.
LAKEWOOD,  NJ,  US.
Initial Importer;  
HITEK CONCEPTS, INC.
LAKEWOOD,  NJ ,  US.
HI-TEK DESIGNS
LONDON,  UK.
Unregistered Foreign Lister;  
HI-TEK DESIGNS
LONDON,  UK.
HITELNET, PT
JAKARTA,  ID.
Foreign Exporter;  
HITELNET, PT
JAKARTA,  ID.
HITESYS S.R.L.
APRILIA (LATINA),  IT.
Manufacturer;  
HITESYS S.R.L.
APRILIA (LATINA),  IT.
HITTER IMPEX
SIALKOT, PUNJAB,  PK.
Manufacturer;  
HITTER IMPEX
SIALKOT, PUNJAB,  PK.
HIVOX BIOTEK CORP.
CERRITOS,  CA,  US.
Initial Importer;  
HIVOX BIOTEK CORP.
CERRITOS,  CA ,  US.
HIVOX BIOTEK, INC.
TAIPEI HSIEN,  TW.
Manufacturer;  
HIVOX BIOTEK, INC.
TAIPEI HSIEN,  TW.
HK LENS DISTRIBUTING CO., INC.
SOUTH OZONE PARK,  NY,  US.
Initial Importer;  
HK LENS DISTRIBUTING CO., INC.
SOUTH OZONE PARK,  NY ,  US.
HK SURGICAL, INC.
SAN CLEMENTE,  CA,  US.
Specification Developer;  
HK SURGICAL, INC.
SAN CLEMENTE,  CA ,  US.
HL CORP. (SHENZHEN)
BAOAN DISTRICT, SHENZHEN,  CH.
Manufacturer;  
HL CORP. (SHENZHEN)
BAOAN DISTRICT, SHENZHEN,  CH.
HLM SALKS, INC.
CRYSTAL LAKE,  IL,  US.
Initial Importer;  
HLM SALKS, INC.
CRYSTAL LAKE,  IL ,  US.
HMB MEDICAL CONCEPTS, LTD.
DERBY,  UK.
Manufacturer;  
HMB MEDICAL CONCEPTS, LTD.
DERBY,  UK.
HMD BIOMEDICAL LLC
TITUSVILLE,  FL,  US.
Initial Importer;  
HMD BIOMEDICAL LLC
TITUSVILLE,  FL ,  US.
HMD BIOMEDICAL, INC.
HSINCHU,  TW.
Manufacturer;   Specification Developer;  
HMD BIOMEDICAL, INC.
HSINCHU,  TW.
HMD MEDICAL TECHNOLOGIES, INC.
BRIDGEWATER,  NJ,  US.
Initial Importer;  
HMD MEDICAL TECHNOLOGIES, INC.
BRIDGEWATER,  NJ ,  US.
HME LTD.
SOUTH MIMMS,  UK.
Contract Manufacturer;   Manufacturer;  
HME LTD.
SOUTH MIMMS,  UK.
HME PROVIDERS INC.
TITUSVILLE,  FL,  US.
Initial Importer;  
HMEPROVIDERS INC.
TITUSVILLE,  FL ,  US.

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Last Modified: 29 April 2006
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