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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
BIOMERIEUX SA
FRANCE,  UK.
Unregistered Foreign Lister;  
BIOMERIEUX SA
MARCY L'ETOILE,  FR.
BIOMERIEUX, INC.
LYON,  FR.
Unregistered Foreign Lister;  
BIOMERIEUX SA
MARCY L'ETOILE,  FR.
BIOMERIEUX, INC.
DURHAM,  NC,  US.
Manufacturer;  
BIOMERIEUX SA
MARCY L'ETOILE,  FR.
BIOMERIEUX, INC.
HAZELWOOD,  MO,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
BIOMERIEUX SA
MARCY L'ETOILE,  FR.
BIOMET CEMENTING TECHNOLOGIES AB
SJOBO,  SW.
Manufacturer;  
BIOMET CEMENTING TECHNOLOGIES AB
SJOBO,  SW.
BIOMET SPAIN ORTHOPAEDICS S.L.
PATERNA, VALENCIA,  SP.
Manufacturer;  
BIOMET, INC.
WARSAW,  IN ,  US.
BIOMET UK LTD.
SOUTH WALES,  UK.
Manufacturer;  
BIOMET UK LTD.
SOUTH WALES,  UK.
BIOMET UK LTD.
SWINDON WILTSHIRE,  UK.
Manufacturer;  
BIOMET UK LTD.
SOUTH WALES,  UK.
BIOMET, INC.
WARSAW,  IN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BIOMET, INC.
WARSAW,  IN ,  US.
BIOMETER INTL. A/S
ODENSE NV,  DA.
Manufacturer;  
BIOMETER INTL. A/S
ODENSE NV,  DA.
BIOMETRICS LTD.
CWMFELINFACH, GWENT,  UK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOMETRICS LTD.
CWMFELINFACH, GWENT,  UK.
BIOMETRIX LTD.
JERUSALEM,  IS.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIOMETRIX LTD.
JERUSALEM,  IS.
BIOMIMETIC THERAPEUTICS, INC.
FRANKLIN,  TN,  US.
Specification Developer;  
BIOMIMETIC THERAPEUTICS, INC.
FRANKLIN,  TN ,  US.
BIOMIST, INC.
PARK RIDGE,  IL,  US.
Specification Developer;  
BIOMIST, INC.
PARK RIDGE,  IL ,  US.
BIOMNI MEDICAL SYSTEMS, INC.
LEHI,  UT,  US.
Initial Importer;   Manufacturer;  
BIOMNI MEDICAL SYSTEMS, INC.
LEHI,  UT ,  US.
BION ENTERPRISES, LTD.
DES PLAINES,  IL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BION ENTERPRISES, LTD.
DES PLAINES,  IL ,  US.
BIONESS, INC.
SANTA CLARITA,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
BIONESS, INC.
SANTA CLARITA,  CA ,  US.
BIONET AMERICA, INC.
TUSTIN,  CA,  US.
Initial Importer;  
BIONET AMERICA, INC.
TUSTIN,  CA ,  US.
BIONET CO., LTD.
SEOUL,  KS.
Manufacturer;  
BIONET COMPANY LTD
SEOUL,  KS.
BIONIC MEDIZINTECHNIK GMBH
FRIEDRICHSDORF,  GM.
Manufacturer;  
JMS CO., LTD.
HIROSHIMA,  JA.
BIONIC PRODUCTS PTY., LTD.
ROBINA, QUEENSLAND,  AS.
Manufacturer;  
BIONIC PRODUCTS PTY., LTD.
ROBINA, QUEENSLAND,  AS.
BIONICA, INC.
MCCLELLAN,  CA,  US.
Manufacturer;  
BIONICA, INC.
MCCLELLAN,  CA ,  US.
BIONICARE MEDICAL TECHNOLOGIES, INC.
SPARKS,  MD,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BIONICARE MEDICAL TECHNOLOGIES, INC.
SPARKS,  MD ,  US.
BIONICHE TEORANTA
CO. GALWAY,  EI.
Manufacturer;  
BIONICHE LIFE SCIENCES, INC.
BELLEVILLE, ONTARIO,  CA.
BIONICS CO., LTD.
GWANG JU,  KS.
Manufacturer;  
BIONICS CO., LTD.
GWANG JU,  KS.
BIONICS USA, INC.
IRVINE,  CA,  US.
Initial Importer;  
BIONICS CO., LTD.
GWANG JU,  KS.
BIONIKE, INC.
BRISBANE,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BIONIKE, INC.
BRISBANE,  CA ,  US.
BIONIME CORPORATION
TAICHUNG COUNTY,  TW.
Manufacturer;  
BIONIME CORPORATION
TAICHUNG COUNTY,  TW.
BIONIX DEVELOPMENT CORP.
TOLEDO,  OH,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BIONIX DEVELOPMENT CORP.
TOLEDO,  OH ,  US.
BIONNOVATION SA
BAURU, SP,  BR.
Manufacturer;  
BIONNOVATION SA
BAURU, SP,  BR.
BIONOR A/S
SKIEN,  NO.
Manufacturer;  
BIONOR A/S
SKIEN,  NO.
BIONOSTICS, INC.
DEVENS,  MA,  US.
Contract Manufacturer;   Manufacturer;  
BIONOSTICS, INC.
DEVENS,  MA ,  US.
BIONTECH CO., LTD.
KYUNGKI-DO,  KS.
Manufacturer;  
BIONTECH CO., LTD.
KYUNGKI-DO,  KS.
BIO-NUCLEAR OF P.R., INC.
CATANO,  PR,  US.
Initial Importer;  
BIO-NUCLEAR OF P.R., INC.
CATANO,  PR ,  US.
BIO-ONE SCIENCES, INC.
AGAWAM,  MA,  US.
Contract Manufacturer;  
BIO-ONE SCIENCES, INC.
AGAWAM,  MA ,  US.
BIO-OPTICA MILANO SPA
MILANO,  IT.
Manufacturer;  
BIO-OPTICA MILANO SPA
MILANO,  IT.
BI-OP LABORATORIES INC.
ST. CHARLES BORROMEE, QUEBEC,  CA.
Manufacturer;  
LANGER, INC.
DEER PARK,  NY ,  US.
BIOPIT CO., LTD.
KASHIWA-SHI, CHIBA,  JA.
Unregistered Foreign Lister;  
BIOPIT CO., LTD.
KASHIWA-SHI, CHIBA,  JA.
BIOPLASTICS CO.
N. RIDGEVILLE,  OH,  US.
Manufacturer;  
BIOPLASTICS CO.
N. RIDGEVILLE,  OH ,  US.
BIOPLATE, INC.
LOS ANGELES,  CA,  US.
Manufacturer;  
BIOPLATE, INC.
LOS ANGELES,  CA ,  US.

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Last Modified: 29 April 2006
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