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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
HAENG LIM MEDICAL CO.
KYUNGKI-DO,  KS.
Unregistered Foreign Lister;  
HAENG LIM MEDICAL CO.
KYUNGKI-DO,  KS.
HAENG LIM SEO WEON
KYOUNGKI-DO,  KS.
Unregistered Foreign Lister;  
HAENG LIM SEO WEON
KYOUNGKI-DO,  KS.
HAENG RIM SEO WON MEDICAL CO.
ANYANG-SI, KYUNGKI-DO,  KS.
Manufacturer;  
HAENG RIM SEO WON MEDICAL CO.
ANYANG-SI, KYUNGKI-DO,  KS.
HAENGLIM SEOWON CORP.
MINEOLA,  NY,  US.
Initial Importer;  
HAENGLIM SEOWON CORP.
MINEOLA,  NY ,  US.
HAFNER CHIRURGISCHE INSTRUMENTE
BALGHEIM,  GM.
Manufacturer;  
HAFNER CHIRURGISCHE INSTRUMENTE
BALGHEIM,  GM.
HAGEMEYER NORTH AMERICA, INC.
RENO,  NV,  US.
Initial Importer;  
HAGEMEYER NORTH AMERICA, INC.
N. CHARLESTON,  SC ,  US.
HAGER & MEISINGER GMBH
NEUSS,  GM.
Manufacturer;  
HAGER & MEISINGER GMBH
NEUSS,  GM.
HAGER & WERKEN GMBH
DUISBURG,  GM.
Manufacturer;  
HAGER & WERKEN GMBH
DUISBURG,  GM.
HAGER & WERKIN GMBH
DUISBURG,  GM.
Unregistered Foreign Lister;  
HAGER & WERKIN GMBH
DUISBURG,  GM.
HAGER WORLDWIDE, INC.
ODESSA,  FL,  US.
Initial Importer;  
HAGER WORLDWIDE, INC.
ODESSA,  FL ,  US.
HAGER WORLDWIDE, INC.
VANCOUVER,  WA,  US.
Initial Importer;  
HAGER WORLDWIDE, INC.
ODESSA,  FL ,  US.
HAGGERTY ENTERPRISES, INC.
ELMHURST,  IL,  US.
Initial Importer;  
HAGGERTY ENTERPRISES, INC.
ELMHURST,  IL ,  US.
HAHDU, INC.
GUANGDONG,  CH.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
HAHDU, INC.
GUANGDONG,  CH.
HAHN MEDICAL INSTRUMENTS MFG. CO.
SEOUL,  KS.
Manufacturer;  
HAHN MEDICAL INSTRUMENTS MFG. CO.
SEOUL,  KS.
HAI DA TRADING USA INC.
BROOKLYN,  NY,  US.
Initial Importer;  
HAI DA TRADING USA INC.
BROOKLYN,  NY ,  US.
HAI LABORATORIES, INC.
LEXINGTON,  MA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HAI LABORATORIES, INC.
LEXINGTON,  MA ,  US.
HAI NAN LATEX INDUSTRIAL CO. LTD.
HAIKOU, HAINAN,  CH.
Manufacturer;  
HAI NAN LATEX INDUSTRIAL CO. LTD.
HAIKOU, HAINAN,  CH.
HAI SURGICAL CORP.
WASHUA,  NH,  US.
Initial Importer;   Specification Developer;  
HAI SURGICAL CORP.
WASHUA,  NH ,  US.
HAI XIANG PLASTIC MOULDING CO., LTD.
DONG GUAN CITY, GUAN DONG PROV,  CH.
Contract Manufacturer;  
HAI XIANG PLASTIC MOULDING CO., LTD.
DONG GUAN CITY, GUAN DONG PROV,  CH.
HAIDER BIOSWING
PULLENREUTH,  GM.
Unregistered Foreign Lister;  
HAIDER BIOSWING
PULLENREUTH,  GM.
HAIDYLENA FOR ADVANCED MEDICAL INDUSTRIES
NASR CITY, CAIRO,  EG.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
HAIDYLENA FOR ADVANCED MEDICAL INDUSTRIES
NASR CITY, CAIRO,  EG.
HAIKOU CITY HAIFA FOREIGN TRADING & INDUSTRIAL CO.
HAIKOU, HAINAN,  CH.
Specification Developer;  
HAIKOU CITY HAIFA FOREIGN TRADING & INDUSTRIAL CO.
HAIKOU, HAINAN,  CH.
HAIKU HOLDINGS LTD
SELANGOR DARUL EHSAN,  MY.
Foreign Exporter;   Specification Developer;   Repackager/Relabeller;  
HAIKU HOLDINGS LTD
SELANGOR DARUL EHSAN,  MY.
HAILUN XINKE TRADING CO.
BEIJING,  CH.
Unregistered Foreign Lister;  
HAILUN XINKE TRADING CO.
BEIJING,  CH.
HAIMEN CHANGLONG INSTRUMENT CO., LTD.
HAIMEN, JIANGSU PROVINCE,  CH.
Manufacturer;  
HU YAXIANG
HAIMEN, JIANGSU,  CH.
HAINAN KANGDA MARINE BIOMEDICAL CORP.
HAINAN PROVINCE,  CH.
Unregistered Foreign Lister;  
HAINAN KANGDA MARINE BIOMEDICAL CORP.
HAINAN PROVINCE,  CH.
HAIR RECONSTRUCTION DEVICES, INC.
ALABANG,MUNTINLUPA,METRO MANIL,  RP.
Manufacturer;  
HAIR RECONSTRUCTION DEVICES, INC.
ALABANG,MUNTINLUPA,METRO MANIL,  RP.
HAI-RAY ENTERPRISE CO. LTD.
TAINAN,  TW.
Manufacturer;  
HAI-RAY ENTERPRISE CO. LTD.
TAINAN,  TW.
HAITONG INDUSTRIAL & TRADING CO., LTD.
WENZHOU, ZHEJIANG,  CH.
Unregistered Foreign Lister;  
HAITONG INDUSTRIAL & TRADING CO., LTD.
WENZHOU, ZHEJIANG,  CH.
HAJ MAX, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
HAJ MAX, INC.
LOS ANGELES,  CA ,  US.
HAJI ALLAH DITTA SURGICAL CORP
SIALKOT,  PK.
Manufacturer;  
HAJI ALLAH DITTA SURGICAL CORP
SIALKOT,  PK.
HAKKO CO., LTD.
NAGANO-KEN,  JA.
Manufacturer;  
HAKKO CO., LTD.
NAGANO-KEN,  JA.
HAKLE-KIMBERLY DEUTSCHLAND GMBH, BEREICH PERSONAL
FORCHEIM,  GM.
Contract Manufacturer;   Manufacturer;  
HAKLE-KIMBERLY DEUTSCHLAND GMBH
KOBLENZ,  GM.
HAKO-MED USA, INC.
HONOLULU,  HI,  US.
Initial Importer;   Manufacturer;  
HAKO-MED USA, INC.
HONOLULU,  HI ,  US.
HAKOMED/EMOS
KARISRUHE,  GM.
Unregistered Foreign Lister;  
HAKOMED/EMOS
KARISRUHE,  GM.
HAKUSUI TRADING, LTD.
OSAKA,  JA.
Unregistered Foreign Lister;  
HAKUSUI TRADING, LTD.
OSAKA,  JA.
HALAL MEAT CORPORATION
FALLS CHURCH,  VA,  US.
Initial Importer;  
HALAL MEAT CORPORATION
FALLS CHURCH,  VA ,  US.
HALATSIS
BELLIGNAT,  FR.
Unregistered Foreign Lister;  
HALATSIS
BELLIGNAT,  FR.
HALCON, INC.
ELGIN,  IL,  US.
Manufacturer;  
HALCON, INC.
ELGIN,  IL ,  US.
HALEKAWEHE, LTD.
HONOLULU,  HI,  US.
Initial Importer;  
CHESTER YOUNG
HONOLULU,  HI ,  US.

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Last Modified: 29 April 2006
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