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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
HARRY D. KOENIG & CO., INC.
EAST ROCKAWAY,  NY,  US.
Initial Importer;  
HARRY D. KOENIG & CO., INC.
EAST ROCKAWAY,  NY ,  US.
HARRY GAO CO.
DIAMOND BAR,  CA,  US.
Initial Importer;  
HARRY GAO CO.
DIAMOND BAR,  CA ,  US.
HARRY J. BOSWORTH CO.
SKOKIE,  IL,  US.
Manufacturer;  
HARRY J. BOSWORTH CO.
SKOKIE,  IL ,  US.
HARRY J. LAWALL & SON, INC.
PHILADELPHIA,  PA,  US.
Manufacturer;  
HARRY J. LAWALL & SON, INC.
PHILADELPHIA,  PA ,  US.
HARRY LARY'S PARIS (MAUDAL SA)
BOULOGNE,  FR.
Specification Developer;  
MAUDAL S.A.
BOULOGNE,  FR.
HARRY PANZER INTL. CORP.
HARRISON,  NY,  US.
Initial Importer;  
HARRY PANZER INTL. CORP.
HARRISON,  NY ,  US.
HARRY RICHARDS
NASHUA,  NH,  US.
Initial Importer;  
HARRY RICHARDS
NASHUA,  NH ,  US.
HART ENTERPRISES, INC.
SPARTA,  MI,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;  
HART ENTERPRISES, INC.
SPARTA,  MI ,  US.
HART ENTERPRISES, INC.
VANCOUVER,  WA,  US.
Initial Importer;  
HART ENTERPRISES, INC.
VANCOUVER,  WA ,  US.
HART ENTERPRISES, INC.
VANCOUVER,  WA,  US.
Initial Importer;  
HART ENTERPRISES, INC.
VANCOUVER,  WA ,  US.
HART INSTITUTE
HENDERSON,  NV,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
HART INSTITUTE
HENDERSON,  NV ,  US.
HART MOBILITY
MISSISSAUGA, ONTARIO,  CA.
Foreign Exporter;  
ANDREW J. HART ENTERPRISES INC.
MISSISSAUGA, ONTARIO,  CA.
HART SPECIALTIES, INC.
AMITYVILLE,  NY,  US.
Initial Importer;  
HART SPECIALTIES, INC.
AMITYVILLE,  NY ,  US.
HARTA INSTRUMENTS
GAITHERSBURG,  MD,  US.
Manufacturer;  
HARTA CORP.
GAITHERSBURG,  MD ,  US.
HARTALEGA SDN BHD
SELANGOR, DARUL EHSAN,  MY.
Manufacturer;  
HARTALEGA SDN BHD
KUALA LUMPUR,  MY.
HARTFORD WALKING SYSTEMS INC.
NEW HARTFORD,  NY,  US.
Manufacturer;  
HARTFORD WALKING SYSTEMS INC.
NEW HARTFORD,  NY ,  US.
HARTMANN-CONCO INC.
ROCK HILL,  SC,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PAUL HARTMANN AG
HEIDENHEIM,  GM.
HARTMANN-SCANDICARE AB
ANDESTORP,  SW.
Manufacturer;  
HARTMANN-SCANDICARE AB
ANDESTORP,  SW.
HARTMUT HOFFMANN
TUTTLINGEN,  GM.
Manufacturer;  
HARTMUT HOFFMANN
TUTTLINGEN,  GM.
HARTMUT OERTEL CHIR. INSTRUMENTE GMBH
TUTTLINGEN,  GM.
Contract Manufacturer;   Manufacturer;  
HARTMUT OERTEL CHIR. INSTRUMENTE GMBH
TUTTLINGEN,  GM.
HARTMUT WILLUTZKI
TUTTLINGEN,  GM.
Contract Manufacturer;  
HARTMUT WILLUTZKI
TUTTLINGEN,  GM.
HARTWELL MEDICAL CORP.
CARLSBAD,  CA,  US.
Manufacturer;   Specification Developer;  
HARTWELL MEDICAL CORP.
CARLSBAD,  CA ,  US.
HARVARD CLINICAL TECHNOLOGY
SOUTH NATICK,  MA,  US.
Contract Manufacturer;   Manufacturer;  
HARVARD CLINICAL TECHNOLOGY
SOUTH NATICK,  MA ,  US.
HARVEST TECHNOLOGIES, CORP.
PLYMOUTH,  MA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;   U.S. Manufacturer of Export Only Devices;
HARVEST TECHNOLOGIES, CORP.
PLYMOUTH,  MA ,  US.
HARVESTER TRADING CO.
BALLWIN,  MO,  US.
Initial Importer;  
HARVESTER TRADING CO.
BALLWIN,  MO ,  US.
HARVEY HUTTER & CO., INC.
OSSINING,  NY,  US.
Initial Importer;  
HARVEY HUTTER & CO., INC.
OSSINING,  NY ,  US.
HARVEY PRECISION INSTRUMENTS
ROTONDA WEST,  FL,  US.
Initial Importer;   Remanufacturer;  
HARVEY PRECISION INSTRUMENTS
ROTONDA WEST,  FL ,  US.
HARVY SURGICAL SUPPLY CORP.
FLUSHING,  NY,  US.
Initial Importer;   Manufacturer;  
HARVY SURGICAL SUPPLY CORP.
FLUSHING,  NY ,  US.
HARYANA CAREWELL LTD.
JIND, HR,  IN.
Manufacturer;  
COLUMBIA TRADERS
VANCOUVER,  WA ,  US.
HASBRO, INC.
PAWTUCKET,  RI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HASBRO, INC.
PAWTUCKET,  RI ,  US.
HASEGAWA OPTICAL COMPANY LIMITED
SABAE-CITY, FUKUI-PREF.,,  JA.
Manufacturer;  
HASEGAWA OPTICAL COMPANY LIMITED
SABAE-CITY, FUKUI-PREF.,,  JA.
HASELL MEDICAL INSTRUMENT CO., LTD.
GOYANG-SI , GYUNGKI-DO,  KS.
Manufacturer;  
HASELL MEDICAL INSTRUMENT CO., LTD.
GOYANG-SI , GYUNGKI-DO,  KS.
HASELMEIER GMBH
BUCHEN,BAWU,  GM.
Manufacturer;  
HASELMEIER GMBH
STUTTGART, BAWU,  GM.
HASENG PLASTIC CO., LTD.
CHONBURI,  TH.
Manufacturer;  
HOMEWARE PLASTICS CO., LTD.
BANGKOK,  TH.
HASSON ENTERPRISES
SIALKOT/PANJAB,  PK.
Manufacturer;  
HASSON ENTERPRISES
SIALKOT/ PANJAB,  PK.
HASTINGS SHOE COMPANY INC.
VEGA BAJA,  PR,  US.
Specification Developer;  
HASTINGS SHOE COMPANY INC.
VEGA BAJA,  PR ,  US.
HATCH CORPORATION
OXNARD,  CA,  US.
Initial Importer;   Specification Developer;  
HATCH CORPORATION
OXNARD,  CA ,  US.
HATCH MEDICAL PRODUCTS, INC.
MILWAUKEE,  WI,  US.
Initial Importer;  
HATCH MEDICAL PRODUCTS, INC.
MILWAUKEE,  WI ,  US.
HATEC
CAP-HAITIEN,  HA.
Contract Manufacturer;  
HATEC
CAP-HAITIEN,  HA.
HATFIELD RUBBER CO.
HATFIELD,  PA,  US.
Contract Manufacturer;   Manufacturer;  
HATFIELD RUBBER CO.
HATFIELD,  PA ,  US.

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Last Modified: 29 April 2006
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