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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
H.P.H. CORP.
CAPE CORAL,  FL,  US.
Initial Importer;  
H.P.H. CORP.
CAPE CORAL,  FL ,  US.
H.P.I. INT'L., INC.
BROOKLYN,  NY,  US.
Initial Importer;  
H.P.I. INT'L., INC.
BROOKLYN,  NY ,  US.
H.R. INDUSTRIA COMERCIO EQUIPAMENTO BIOMED LTDA
PORTO ALEGRE,  BR.
Manufacturer;  
H.R. INDUSTRIA COMERCIO EQUIPAMENTO BIOMED LTDA
PORTO ALEGRE,  BR.
H.S HOSPITAL SERVICE S.P.A.
ITALIA,  IT.
Manufacturer;  
H.S HOSPITAL SERVICE S.P.A.
ITALIA,  IT.
H.S. INTERNATIONAL ENTERPRISES CORP.
MIAMI,  FL,  US.
Initial Importer;  
H.S. INTERNATIONAL ENTERPRISES CORP.
MIAMI,  FL ,  US.
H.S. INTL. CO., INC.
CONCORD,  CA,  US.
Manufacturer;  
H.S. INTL. CO., INC.
CONCORD,  CA ,  US.
H.S. MERIDIAN, INC.
EDEN PRAIRIE,  MN,  US.
Initial Importer;  
MERIDIAN AG
BERNE-LIEBEFELD,  SZ.
H.T.A SURGICAL
WEST HAVEN,  CT,  US.
Initial Importer;  
H.T.A SURGICAL
WEST HAVEN,  CT ,  US.
H.W. RUTZEN & SON, INC.
CHICAGO,  IL,  US.
Manufacturer;  
H.W. RUTZEN & SON, INC.
CHICAGO,  IL ,  US.
H.W. STEPHENS, M.D.
ALLENTOWN,  PA,  US.
Specification Developer;  
H.W. STEPHENS, M.D.
ALLENTOWN,  PA ,  US.
H20ONLY CO.
BAY CITY,  MI,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SERV-A-PURE COMPANY
BAY CITY,  MI ,  US.
H2O RAMPS AND LIFTS, LLC
GREERS FERRY,  AR,  US.
Manufacturer;  
H2O RAMPS AND LIFTS, LLC
GREERS FERRY,  AR ,  US.
H2OR, INC.
TULSA,  OK,  US.
Manufacturer;   Specification Developer;  
H2OR, INC.
TULSA,  OK ,  US.
H3D
LAVANCIA-EPERCY,  FR.
Specification Developer;   Repackager/Relabeller;  
H3D
LAVANCIA-EPERCY,  FR.
HA NEE OPTICAL CO., LTD
GONGJU-CITY, CHUNGNAM,  KS.
Manufacturer;  
HA NEE OPTICAL CO., LTD
GONGJU-CITY, CHUNGNAM,  KS.
HAAG STREIT UK LTD.
HARLOW, ESSEX,  UK.
Foreign Exporter;   Specification Developer;  
HAAG-STREIT HOLDING AG
KOENIZ,  SZ.
HAAG-STREIT AG
KOENIZ,  SZ.
Manufacturer;  
HAAG-STREIT HOLDING AG
KOENIZ,  SZ.
HAAG-STREIT USA, INC.
MASON,  OH,  US.
Initial Importer;  
HAAG-STREIT HOLDING AG
KOENIZ,  SZ.
HAAS PRECISION INDUSTRIES, INC.
WILLOWRROOK,  IL,  US.
Initial Importer;  
CARL HAAS GMBH & CO.
SCHRAMBERG,  GM.
HAB TRADING, CO.
SEOUL,  KS.
Manufacturer;  
HAB TRADING, CO.
SEOUL,  KS.
HABERVISION, LLC
GOLDEN,  CO,  US.
Initial Importer;  
HABERVISION, LLC
GOLDEN,  CO ,  US.
HABILIS, INC.
MILFORD,  CT,  US.
Manufacturer;  
OPTIMA, INC.
STRATFORD,  CT ,  US.
HABITAT, INC.
NEW YORK,  NY,  US.
Initial Importer;  
HABITAT, INC.
NEW YORK,  NY ,  US.
HACH COMPANY
AMES,  IA,  US.
Contract Manufacturer;   Manufacturer;  
HACH COMPANY
ELKHART,  IN ,  US.
HACHI CO., LTD.
TAIPEI,  TW.
Manufacturer;  
HACHI CO., LTD.
TAIPEI,  TW.
HACHI INTL., INC.
NEW YORK,  NY,  US.
Initial Importer;  
HACHI INTL., INC.
NEW YORK,  NY ,  US.
HACKER INDUSTRIES, INC.
WINNSBORO,  SC,  US.
Initial Importer;   Manufacturer;  
HACKER INDUSTRIES, INC.
WINNSBORO,  SC ,  US.
HADECO, INC.
KAWASAKI-SHI,  JA.
Manufacturer;  
HADECO, INC.
KAWASAKI-SHI,  JA.
HAE SUNG MEDICAL CO
SEOUL,  KS.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HAE SUNG MEDICAL CO
SEOUL,  KS.
HAELAN MEDICAL, INC.
MISSOURI CITY,  TX,  US.
Initial Importer;  
HAELAN MEDICAL, INC.
MISSOURI CITY,  TX ,  US.
HAEMACHEM, INC.
ST. LOUIS,  MO,  US.
Manufacturer;  
HAEMACHEM, INC.
ST. LOUIS,  MO ,  US.
HAEMACURE CORP.
SARASOTA,  FL,  US.
Specification Developer;  
HAEMACURE CORP.
MONTREAL, QUEBEC,  CA.
HAEMONETICS CORP.
STRATHCLYDE, SCOTLAND,  UK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HAEMONETICS CORP.
BRAINTREE,  MA ,  US.
HAEMONETICS CORP.
AVON,  MA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
HAEMONETICS CORP.
BRAINTREE,  MA ,  US.
HAEMONETICS CORP.
BRAINTREE,  MA,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
HAEMONETICS CORP.
BRAINTREE,  MA ,  US.
HAEMONETICS CORP.
LEETSDALE,  PA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
HAEMONETICS CORP.
BRAINTREE,  MA ,  US.
HAEMONETICS CORP.
UNION,  SC,  US.
Contract Manufacturer;   Manufacturer;   Contract Sterilizer;  
HAEMONETICS CORP.
BRAINTREE,  MA ,  US.
HAEMOSCOPE CORP.
NILES,  IL,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
HAEMOSCOPE CORP.
NILES,  IL ,  US.
HAEMOTRONIC SPA ADVANCED MEDICAL TECHNOLOGIES
MIRANDOLA,  IT.
Manufacturer;  
HAEMOTRONIC, SPA
MIRANDOLA (MO),  IT.
HAEMOTRONIC, S.P.A. ADVANCED MEDICAL TECHNOLOGIES
CARBONARA DI PO (MANTOVA),  IT.
Contract Manufacturer;  
HAEMOTRONIC, SPA
MIRANDOLA (MO),  IT.

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Last Modified: 29 April 2006
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