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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
HARBIN KANGYIBAO HEALTH-PROTECTING ARTICLES CO. LT
HARBIN, HEILONGJIANG,  CH.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
HARBIN KANGYIBAO HEALTH-PROTECTING ARTICLES CO. LT
HARBIN, HEILONGJIANG,  CH.
HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.
HEILONGJIANG,  CH.
Manufacturer;  
HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.
HEILONGJIANG,  CH.
HARBINGER MEDICAL, INC.
EDEN PRAIRIE,  MN,  US.
Specification Developer;  
HARBINGER MEDICAL, INC.
EDEN PRAIRIE,  MN ,  US.
HARBOR EXCHANGE CORP
FORT LAUDERDALE,  FL,  US.
Initial Importer;  
HARBOR EXCHANGE CORP
FORT LAUDERDALE,  FL ,  US.
HARBOR MEDICAL DEVICES, INC.
JAFFREY,  NH,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HARBOR MEDICAL DEVICES, INC.
JAFFREY,  NH ,  US.
HARBOR MEDICAL INC.
JARRETTSVILLE,  MD,  US.
Initial Importer;  
HARBOR MEDICAL INC.
JARRETTSVILLE,  MD ,  US.
HARBOR METALCRAFTERS, INC./MEDPRO
BAYSHORE,  NY,  US.
Manufacturer;   Remanufacturer;  
HARBOR METALCRAFTERS, INC./MEDPRO
BAYSHORE,  NY ,  US.
HARBOUR INT'L ENTERPRISE LTD
KOWLOON BAY, KOWLOON,  HK.
Manufacturer;  
HEADMASTER LIMITED
KOWLOON BAY, KOWLOON,  HK.
HARD MFG. CO., INC.
BUFFALO,  NY,  US.
Manufacturer;  
HARD MFG. CO., INC.
BUFFALO,  NY ,  US.
HARDCOVER PRODUCTS, INC.
CONCORD, ONTARIO,  CA.
Manufacturer;  
HARDCOVER PRODUCTS, INC.
CONCORD, ONTARIO,  CA.
HARDING INDUSTRIES, INC.
MORRISTOWN,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
HARDING INDUSTRIES, INC.
MORRISTOWN,  NJ ,  US.
HARDWORKING CORP.
SIALKOT,  PK.
Manufacturer;  
HARDWORKING CORP.
SIALKOT,  PK.
HARDY DIAGNOSTICS
SANTA MARIA,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HARDY DIAGNOSTICS
SANTA MARIA,  CA ,  US.
HARDY MEDICAL COMMUNICATIONS, INC.
MASSAPEQUA,  NY,  US.
Initial Importer;   Specification Developer;  
HARDY MEDICAL COMMUNICATIONS, INC.
MASSAPEQUA,  NY ,  US.
HARIBHAI ENT., INC.
ARLINGTON,  TX,  US.
Initial Importer;  
HARIBHAI ENT., INC.
ARLINGTON,  TX ,  US.
HARITEX CORP.
TAIPEI,  TW.
Manufacturer;  
HARITEX CORP.
TAIPEI,  TW.
HARKEN INC.
PEWAUKEE,  WI,  US.
Initial Importer;  
HARKEN INC.
PEWAUKEE,  WI ,  US.
HARLAN BIOPRODUCTS FOR SCIENCE, INC.
MADISON,  WI,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HARLAN BIOPRODUCTS FOR SCIENCE, INC.
INDIANAPOLIS,  IN ,  US.
HARLEY-DAVIDSON MOTOR COMPANY, INC.
MILWAUKEE,  WI,  US.
Initial Importer;  
HARLEY-DAVIDSON MOTOR COMPANY, INC.
MILWAUKEE,  WI ,  US.
HARMAC MEDICAL PRODUCTS LIMITED
CASTLEREA, ROSCOMMON,  EI.
Contract Manufacturer;   Manufacturer;  
HARMAC MEDICAL PRODUCTS, INC.
BUFFALO,  NY ,  US.
HARMAC MEDICAL PRODUCTS, INC.
BUFFALO,  NY,  US.
Contract Manufacturer;   Manufacturer;  
HARMAC MEDICAL PRODUCTS, INC.
BUFFALO,  NY ,  US.
HARMAN ENT.
STOW,  MA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
HARMAN ENT.
STOW,  MA ,  US.
HAR-MED GMBH
FRIDINGEN,  GM.
Repackager/Relabeller;  
HAR-MED GMBH
FRIDINGEN,  GM.
HARMONIX CORP.
BOCA RATON,  FL,  US.
Initial Importer;  
HARMONIX CORP.
BOCA RATON,  FL ,  US.
HARMONIZER
KENT,  OH,  US.
Initial Importer;   Manufacturer;  
HARMONIZER
KENT,  OH ,  US.
HARMONY BRANDS, L.L.C.
OAK PARK,  MI,  US.
Initial Importer;  
HARMONY BRANDS, L.L.C.
OAK PARK,  MI ,  US.
HARMONY ENTERPRISES AMERICA, INC.
DANBURY,  CT,  US.
Initial Importer;  
HARMONY ENTERPRISES AMERICA, INC.
DANBURY,  CT ,  US.
HARMONY IN LIVING
LOS ANGELES,  CA,  US.
Initial Importer;  
HARMONY IN LIVING
LOS ANGELES,  CA ,  US.
HARRELL MEDICAL, INC.
CANBY,  OR,  US.
Initial Importer;  
HARRELL MEDICAL, INC.
CANBY,  OR ,  US.
HARRIGAN MEDICAL PRODUCTS, INC.
MANCHESTER,  VT,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HARRIGAN MEDICAL PRODUCTS, INC.
MANCHESTER,  VT ,  US.
HARRINGTON CONSULTING
LEXINGTON,  SC,  US.
Initial Importer;  
HARRINGTON CONSULTING
LEXINGTON,  SC ,  US.
HARRIS CALORIFIC
GAINESVILLE,  GA,  US.
Manufacturer;  
HARRIS CALORIFIC
GAINESVILLE,  GA ,  US.
HARRIS GOVERNMENT COMMUNICATIONS SYSTEMS DIVISION
MALABAR,  FL,  US.
Manufacturer;  
HARRIS GOVERNMENT COMMUNICATIONS SYSTEMS DIVISION
PALM BAY,  FL ,  US.
HARRIS RESEARCH & DEVELOPMENT, LLC.
OREM,  UT,  US.
Manufacturer;  
HARRIS RESEARCH & DEVELOPMENT, LLC.
OREM,  UT ,  US.
HARRIS STAIR CLIMBER
DERWOOD,  MD,  US.
Specification Developer;  
HARRIS STAIR CLIMBER
DERWOOD,  MD ,  US.
HARRISON & CARDILLO DENTAL LAB
KIRKLAND,  WA,  US.
Initial Importer;   Manufacturer;  
SENTAGE CORPORATION
MINNEAPOLIS,  MN ,  US.
HARRISON & CARDILLO DENTAL LAB
TACOMA,  WA,  US.
Manufacturer;  
SENTAGE CORPORATION
MINNEAPOLIS,  MN ,  US.
HARRISON DISCOUNTS
MCKEES ROCKS,  PA,  US.
Initial Importer;  
HARRISON DISCOUNTS
MCKEES ROCKS,  PA ,  US.
HARRISON SPECIALTY CO., INC.
CANTON,  MA,  US.
Contract Manufacturer;   Manufacturer;  
HARRISON SPECIALTY CO., INC.
CANTON,  MA ,  US.
HARRISON-DANIELS, INCORPORATED
ENGLEWOOD CLIFFS,  NJ,  US.
Initial Importer;  
HARRISON-DANIELS, INCORPORATED
ENGLEWOOD CLIFFS,  NJ ,  US.

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Last Modified: 29 April 2006
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