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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
HELLER LABORATORIES
SPARKS,  NV,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HELLER LABORATORIES
SPARKS,  NV ,  US.
HELLIGE GMBH
GM.
Manufacturer;  
HELLIGE GMBH
GM.
HELM INCORPORATED
HIGHLAND PARK,  MI,  US.
Initial Importer;  
HELM INCORPORATED
HIGHLAND PARK,  MI ,  US.
HELMER INC.
NOBLESVILLE,  IN,  US.
Manufacturer;  
HELMER INC.
NOBLESVILLE,  IN ,  US.
HELMER INC.
NOBLESVILLE,  IN,  US.
Manufacturer;  
HELMER INC.
NOBLESVILLE,  IN ,  US.
HELMUT HUND GMBH
WETZLAR,  GM.
Manufacturer;  
HELMUT HUND GMBH
WETZLAR,  GM.
HELMUT KAUPP
TUTTLINGEN,  GM.
Manufacturer;  
HELMUT KAUPP
TUTTLINGEN,  GM.
HELMUT ROCK GMBH
LENNINGEN,  GM.
Unregistered Foreign Lister;  
HELMUT ROCK GMBH
LENNINGEN,  GM.
HELMUT ZEPF MEDIZINTECHNIK GMBH
SEITINGEN,  GM.
Manufacturer;  
HELMUT ZEPF MEDIZINTECHNIK GMBH
SEITINGEN,  GM.
HELPING HAND CO., LTD.
HEREFORDSHIRE,  UK.
Manufacturer;  
HELPING HAND CO., LTD.
HEREFORDSHIRE,  UK.
HELVETIA DEVELOPMENT CO. LLC.
KALAMAZOO,  MI,  US.
Manufacturer;  
HELVETIA DEVELOPMENT CO. LLC.
NOBLESVILLE,  IN ,  US.
HELY AND WEBER
SANTA PAULA,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HELY AND WEBER
SANTA PAULA,  CA ,  US.
HEMA METRICS, INC.
KAYSVILLE,  UT,  US.
Manufacturer;  
HEMA METRICS, INC.
KAYSVILLE,  UT ,  US.
HEMAEDICS, INC.
BRENTWOOD,  CA,  US.
Specification Developer;  
HEMAEDICS, INC.
BRENTWOOD,  CA ,  US.
HEMAGEN DIAGNOSTICS, INC.
COLUMBIA,  MD,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HEMAGEN DIAGNOSTICS, INC.
COLUMBIA,  MD ,  US.
HEM-AIDE COMPANY, INC.
MINNEAPOLIS,  MN,  US.
Manufacturer;  
HEM-AIDE COMPANY, INC.
MINNEAPOLIS,  MN ,  US.
HEMASOURCE, INC.
WEST JORDAN,  UT,  US.
Initial Importer;  
HEMASOURCE, INC.
WEST JORDAN,  UT ,  US.
HEMATECHNOLOGIES LTD.
GLASGOW, SCOTLAND,  UK.
Manufacturer;  
HEMATECHNOLOGIES, INC.
LEBANON,  NJ ,  US.
HEMATECHNOLOGIES, INC.
LEBANON,  NJ,  US.
Initial Importer;  
HEMATECHNOLOGIES, INC.
LEBANON,  NJ ,  US.
HEMCON, INC.
TIGARD,  OR,  US.
Manufacturer;  
HEMCON, INC.
TIGARD,  OR ,  US.
HEMEDEX INCORPORATED
CAMBRIDGE,  MA,  US.
Manufacturer;  
HEMEDEX INCORPORATED
CAMBRIDGE,  MA ,  US.
HEMERUS MEDICAL, LLC.
ST. PAUL,  MN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
HEMERUS MEDICAL, LLC.
ST.PAUL,  MN ,  US.
HEMING, INC.
ALHAMBRA,  CA,  US.
Manufacturer;  
HEMING, INC.
ALHAMBRA,  CA ,  US.
HEMISPHERES MARKETING CO. LTD.
COOPER CITY,  FL,  US.
Initial Importer;  
HEMISPHERES MARKETING CO. LTD.
COOPER CITY,  FL ,  US.
HEMO DIAGNOSTICA, LLC
CORNELIUS,  NC,  US.
Initial Importer;   Specification Developer;  
HEMO DIAGNOSTICA, LLC
CORNELIUS,  NC ,  US.
HEMO SAPIENS, INC.
SEDONA,  AZ,  US.
Manufacturer;  
HEMO SAPIENS, INC.
SEDONA,  AZ ,  US.
HEMOCLEANSE, INC.
LAFAYETTE,  IN,  US.
Specification Developer;  
HEMOCLEANSE, INC.
LAFAYETTE,  IN ,  US.
HEMOCUE AB
ANGELHOLM,  SW.
Manufacturer;  
HEMOCUE HOLDING AB
ANGELHOLM,  SW.
HEMOCUE, INC.
LAKE FOREST,  CA,  US.
Initial Importer;  
HEMOCUE HOLDING AB
ANGELHOLM,  SW.
HEMO-DE, INC.
KELLER,  TX,  US.
Manufacturer;  
SCIENTIFIC SAFETY SOLVENTS
KELLER,  TX ,  US.
HEMODIA SA
LABEGE,  FR.
Contract Manufacturer;   Contract Sterilizer;   Repackager/Relabeller;  
HEMODIA SA
LABEGE,  FR.
HEMOMEDEX TRADING CO.
DANVILLE,  CA,  US.
Repackager/Relabeller;  
HEMOMEDEX TRADING CO.
DANVILLE,  CA ,  US.
HEMOSCIENCE, INC.
RALEIGH,  NC,  US.
Specification Developer;   Repackager/Relabeller;  
HEMOSCIENCE, INC.
RALEIGH,  NC ,  US.
HEMOSENSE, INC.
SAN JOSE,  CA,  US.
Manufacturer;  
HEMOSENSE, INC.
SAN JOSE,  CA ,  US.
HEMOSOL, INC.
ETOBICOKE,  CA.
Unregistered Foreign Lister;  
HEMOSOL, INC.
ETOBICOKE,  CA.
HEMOSYSTEM S.A.
MARSEILLE,  FR.
Manufacturer;   Specification Developer;  
HEMOSYSTEM S.A.
MARSEILLE,  FR.
HEM-SOL
BANKERYD,  SW.
Unregistered Foreign Lister;  
HEM-SOL
BANKERYD,  SW.
HENAN COLGATE TOOTHBRUSH CO. LTD.
ZHENGZHOU,  CH.
Unregistered Foreign Lister;  
HENAN COLGATE TOOTHBRUSH CO. LTD.
ZHENGZHOU,  CH.
HENAN MEDICINES & HEALTH PRODUCTS I/E CORP.
ZHENGHOU, HENAN,  CH.
Unregistered Foreign Lister;  
HENAN MEDICINES & HEALTH PRODUCTS I/E CORP.
ZHENGHOU, HENAN,  CH.
HENDRICKS ORTHOTIC PROSTHETIC ENTERPRISES, INC.
ORLANDO,  FL,  US.
Initial Importer;   Manufacturer;  
HENDRICKS ORTHOTIC PROSTHETIC ENTERPRISES, INC.
ORLANDO,  FL ,  US.

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Last Modified: 29 April 2006
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