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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
HEAVENLY WATER
ST CLAIRSVILLE,  OH,  US.
Specification Developer;  
HEAVENLY WATER
ST CLAIRSVILLE,  OH ,  US.
HEBEI MANFUL IMPORT & EXPORT CO., LTD.
JINZHOU CITY, HEBEI,  CH.
Manufacturer;  
HEBEI MANFUL IMPORT & EXPORT CO., LTD.
JINZHOU CITY, HEBEI,  CH.
HEBUMEDICAL GMBH
TUTTLINGEN,  GM.
Manufacturer;  
HEBUMEDICAL GMBH
TUTTLINGEN,  GM.
HEDD INDUSTRY CORP.
TAIPEI,  TW.
Manufacturer;  
HEDD INDUSTRY CORP.
TAIPEI,  TW.
HEDONIST BIOCHEMICAL TECHNOLOGIES (USA), INC.
PLANO,  TX,  US.
Specification Developer;  
HEDONIST BIOCHEMICAL TECHNOLOGIES (USA), INC.
PLANO,  TX ,  US.
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.
TAIPEI,  TW.
Specification Developer;  
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.
TAIPEI,  TW.
HEESUNG ENGELHARD CORP.
SEOUL,  KS.
Manufacturer;  
HEESUNG ENGELHARD CORP.
SEOUL,  KS.
HEEYOUNG CO., LTD.
ANSAN CITY, KYUNGGI-DO,  KS.
Manufacturer;  
HEEYOUNG CO., LTD.
ANSAN CITY, KYUNGGI-DO,  KS.
HEFEI IMP. & EXP. CORP.
HEFEI,  CH.
Unregistered Foreign Lister;  
HEFEI IMP. & EXP. CORP.
HEFEI,  CH.
HEFEI JINGCHENG NON-WOVEN PRODUCTS CO., LTD.
HEFEI ANHUI,  CH.
Manufacturer;  
SHANGHAI TIAN MAO INTL. TRADING CO., LTD.
SHANGHAI,  CH.
HEHE OPTICAL CO., CORP. (USA)
SOUTH EL MONTE,  CA,  US.
Initial Importer;  
HEHE OPTICAL CO., CORP. (USA)
SOUTH EL MONTE,  CA ,  US.
HEI, INC.
BOULDER,  CO,  US.
Contract Manufacturer;   Specification Developer;  
HEI, INC.
VICTORIA,  MN ,  US.
HEICO SWITZERLAND NACHFOLGER MARTIN EGLI
STEINACH,  SZ.
Contract Manufacturer;   Manufacturer;  
HEICO SWITZERLAND
STEINACH,  SZ.
HEIDELBERG ENGINEERING
HEIDELBERG,  GM.
Manufacturer;  
HEIDELBERG ENGINEERING
HEIDELBERG,  GM.
HEIDELBERG ENGINEERING
VISTA,  CA,  US.
Initial Importer;  
HEIDELBERG ENGINEERING
VISTA,  CA ,  US.
HEIDELBERG MEDICAL, INC.
BLAIRSVILLE,  GA,  US.
Initial Importer;   Manufacturer;  
HEIDELBERG MEDICAL, INC.
BLAIRSVILLE,  GA ,  US.
HEIDI GATSCHER
TUTTLINGEN,  GM.
Manufacturer;  
GAMED HEIDI GATSCHER
TUTTLINGEN,  GM.
HEIDOLPH INSTRUMENTS, INC.
CINAMINSON,  NJ,  US.
Initial Importer;  
HEIDOLPH INSTRUMENTS, INC.
CINAMINSON,  NJ ,  US.
HEIGA USA, INC.
PLANTATION,  FL,  US.
Initial Importer;  
HEIGA USA, INC.
PLANTATION,  FL ,  US.
HEIGHTS HOME HEALTH CARE & SURGICAL SUPPLIES, INC.
STATEN,  NY,  US.
Initial Importer;  
HEIGHTS HOME HEALTH CARE & SURGICAL SUPPLIES, INC.
STATEN,  NY ,  US.
HEILONGJIANG RUIFA WOODEN PRODUCTS CO., LTD.
HEILONGJIANG PROVINCE,  CH.
Contract Manufacturer;  
HEILONGJIANG RUIFA WOODEN PRODUCTS CO., LTD.
HEILONGJIANG PROVINCE,  CH.
HEILONGJIANG TAI DONG METAL PRODUCTS CO., LTD.
HARBIN, HEILONGJIANG,  CH.
Manufacturer;  
HEILONGJIANG TAI DONG METAL PRODUCTS CO., LTD.
HARBIN, HEILONGJIANG,  CH.
HEINE OPTOTECHNIK GMBH & CO. KG.
HERRSCHING,  GM.
Manufacturer;  
HEINE OPTOTECHNIK GMBH & CO. KG.
HERRSCHING,  GM.
HEINE USA, LTD.
DOVER,  NH,  US.
Initial Importer;  
HEINE OPTOTECHNIK GMBH & CO. KG.
HERRSCHING,  GM.
HEINKE TECHNOLOGY, INC.
LINCOLN,  NE,  US.
Manufacturer;  
HEINKE TECHNOLOGY, INC.
LINCOLN,  NE ,  US.
HEINZ DOLDERER
7200 TUTTLINGEN,  GM.
Manufacturer;  
HEINZ DOLDERER
7200 TUTTLINGEN,  GM.
HEINZ KETTLER GMBH & CO. KG
ENSE-PARSIT,  GM.
Manufacturer;  
HEINZ KETTLER GMBH & CO. KG
ENSE-PARSIT,  GM.
HEINZ KETTLER METALLWARENFABRIK GMBH
ENSE-PARSIT,  GM.
Manufacturer;  
HEINZ KETTLER METALLWARENFABRIK GMBH
ENSE-PARSIT,  GM.
HEINZ KURZ GMBH MEDIZINTECHNIK
DUSSLINGEN,  GM.
Manufacturer;  
HEINZ KURZ GMBH MEDIZINTECHNIK
DUSSLINGEN,  GM.
HEINZ ROOS
SEITINGEN,  GM.
Manufacturer;  
HEINZ ROOS
SEITINGEN,  GM.
HEINZ SCHIEBLER
FLENBURG,  GM.
Manufacturer;  
HEINZ SCHIEBLER
FLENBURG,  GM.
HEIWA MEDIC CO., LTD.
TAKAYAMA, GIFU-PREF,  JA.
Contract Manufacturer;  
HEIWA MEDIC CO., LTD.
TAKAYAMA, GIFU-PREF,  JA.
HELENA LABORATORIES
BEAUMONT,  TX,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HELENA LABORATORIES
BEAUMONT,  TX ,  US.
HELENA LABORATORIES
BEAUMONT,  TX,  US.
Manufacturer;   Remanufacturer;  
HELENA LABORATORIES
BEAUMONT,  TX ,  US.
HELIARC SPECIALISTS, INC.
PORTLAND,  OR,  US.
Manufacturer;  
HELIARC SPECIALISTS, INC.
PORTLAND,  OR ,  US.
HELICA INSTRUMENTS, LTD
RICCARTON, EDINBURGH,  UK.
Manufacturer;  
HELICA INSTRUMENTS, LTD
RICCARTON, EDINBURGH,  UK.
HELICOR, INC.
NEW YORK,  NY,  US.
Specification Developer;  
HELICOR, INC.
NEW YORK,  NY ,  US.
HELIO BALANCE
BELLEVUE,  WA,  US.
Initial Importer;   Manufacturer;  
KELSUN DIST.
BELLEVUE,  WA ,  US.
HELIO MEDICAL SUPPLIES, INC.
SAN JOSE,  CA,  US.
Initial Importer;   Manufacturer;  
HELIO MEDICAL SUPPLIES, INC.
SAN JOSE,  CA ,  US.
HELIX MEDICAL, INC.
CARPINTERIA,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HELIX MEDICAL, INC.
CARPINTERIA,  CA ,  US.

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Last Modified: 29 April 2006
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