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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
AERIFORM CORP.
PASADENA,  TX,  US.
Manufacturer;  
AERIFORM CORP.
HOUSTON,  TX ,  US.
AERIS THERAPEUTICS, INC.
WOBURN,  MA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AERIS THERAPEUTICS, INC.
WOBURN,  MA ,  US.
AERO CONTACT LENS, INC.
KALAMAZOO,  MI,  US.
Manufacturer;   Specification Developer;  
AERO CONTACT LENS, INC.
KALAMAZOO,  MI ,  US.
AERO MEDICAL PRODUCTS CO., INC.
WEST BEND,  WI,  US.
Manufacturer;  
AERO MEDICAL PRODUCTS CO., INC.
WEST BEND,  WI ,  US.
AERO PRODUCTS CORP.
SANFORD,  FL,  US.

AERO PRODUCTS CORP.
SANFORD,  FL ,  US.
AEROCARE INDUSTRIES SDN BHD
SELANGOR,  MY.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AEROCARE INDUSTRIES SDN BHD
SELANGOR,  MY.
AEROCRINE AB
SE-171 73 SOLNA,  SW.
Manufacturer;   Specification Developer;  
AEROCRINE AB
SE-171 73 SOLNA,  SW.
AEROCRINE, INC.
CHICAGO,  IL,  US.
Initial Importer;  
AEROCRINE AB
SE-171 73 SOLNA,  SW.
AEROLITE INDUSTRIAL CO., LTD.
FOTAN, SHATIN,  HK.
Unregistered Foreign Lister;  
AEROLITE INDUSTRIAL CO., LTD.
FOTAN, SHATIN,  HK.
AEROMAX INC.
BROOKLYN,  NY,  US.
Initial Importer;  
AEROMAX INC.
BROOKLYN,  NY ,  US.
AERO-MED LTD.
GLASTONBURY,  CT,  US.
Initial Importer;  
AERO-MED LTD.
GLASTONBURY,  CT ,  US.
AEROMEDIC INNOVATIONS GROUP
UXBRIDGE,  UK.
Manufacturer;  
AEROMEDIC INNOVATIONS GROUP
UXBRIDGE,  UK.
AEROSOL AND LIQUID PACKAGING, INC.
BALTIMORE,  MD,  US.
Contract Manufacturer;   Repackager/Relabeller;  
AEROSOL AND LIQUID PACKAGING, INC.
BALTIMORE,  MD ,  US.
AEROSOL SERVICES, INC.
CITY OF INDUSTRY,  CA,  US.
Contract Manufacturer;   Manufacturer;  
AEROSOL SERVICES, INC.
CITY OF INDUSTRY,  CA ,  US.
AEROTECH - KALMAR LABORATORIES, INC.
PHOENIX,  AZ,  US.
Contract Manufacturer;   Manufacturer;   Contract Sterilizer;  
AEROTECH - KALMAR LABORATORIES, INC.
PHOENIX,  AZ ,  US.
AERO-TECH ENGINEERING, INC.
WICHITA,  KS,  US.
Contract Manufacturer;  
AERO-TECH ENGINEERING, INC.
WICHITA,  KS ,  US.
AEROTEL MEDICAL SYSTEMS (1998) LTD.
HOLON,  IS.
Manufacturer;  
AEROTEL MEDICAL SYSTEMS (1998) LTD.
HOLON,  IS.
AEROTEL MEDICAL USA
DALLAS,  TX,  US.
Initial Importer;  
AEROTEL MEDICAL USA
DALLAS,  TX ,  US.
AERSCHER DIAGNOSTICS
CHESTERTOWN,  MD,  US.
Manufacturer;  
AERSCHER DIAGNOSTICS
CHESTERTOWN,  MD ,  US.
AERUS, LLC
DALLAS,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
AERUS, LLC
DALLAS,  TX ,  US.
AES OPTICS
SENATOBIA,  MS,  US.
Initial Importer;   Specification Developer;  
AES OPTICS
SENATOBIA,  MS ,  US.
AESCULAP AG & CO. KG.
TUTTLINGEN, DONAU,  GM.
Manufacturer;  
AESCULAP AG & CO. KG.
TUTTLINGEN,  GM.
AESCULAP SURGICAL INDUSTRIES SDN BHD
PENANG,  MY.
Manufacturer;  
AESCULAP AG & CO. KG.
TUTTLINGEN,  GM.
AESCULAP, INC.
CENTER VALLEY,  PA,  US.
Initial Importer;   Specification Developer;  
AESCULAP, INC.
CENTER VALLEY,  PA ,  US.
AESCULAP, INC.
HAZELWOOD,  MO,  US.
Initial Importer;   Repackager/Relabeller;  
AESCULAP, INC.
CENTER VALLEY,  PA ,  US.
AESKU, INC
MIAMI,  FL,  US.
Initial Importer;  
AESKU.DIAGNOSTICS
WENDELSHEIM,  GM.
AESKU.DIAGNOSTICS
WENDELSHEIM,  GM.
Foreign Exporter;   Manufacturer;  
AESKU.DIAGNOSTICS
WENDELSHEIM,  GM.
AESTHERA CORPORATION
PLEASANTON,  CA,  US.
Manufacturer;   Specification Developer;  
AESTHERA CORPORATION
PLEASANTON,  CA ,  US.
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
RENO,  NV,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
RENO,  NV ,  US.
AESTHETIC DEVICES, INC.
NOVATO,  CA,  US.
Contract Manufacturer;  
AESTHETIC DEVICES, INC.
NOVATO,  CA ,  US.
AESTHETIC INNOVATIONS, INC.
NASHVILLE,  TN,  US.
Manufacturer;  
AESTHETIC INNOVATIONS, INC.
NASHVILLE,  TN ,  US.
AESTHETIC SKIN CARE IMPORTERS, LTD.
BALTIMORE,  MD,  US.
Initial Importer;  
AESTHETIC SKIN CARE IMPORTERS, LTD.
BALTIMORE,  MD ,  US.
AESTHETIC TECHNOLOGIES
GOLDEN,  CO,  US.
Initial Importer;   Specification Developer;  
AESTHETIC TECHNOLOGIES
GOLDEN,  CO ,  US.
AESTHETIC USA, INC.
BAYAMON,  PR,  US.
Initial Importer;  
AESTHETIC USA INC.
BAYAMON,  PR ,  US.
AETNA FELT CORP.
ALLENTOWN,  PA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AETNA FELT CORP.
ALLENTOWN,  PA ,  US.
AEVERL MEDICAL, LLC
GAINESVILLE,  GA,  US.
Manufacturer;  
AEVERL MEDICAL, LLC
GAINESVILLE,  GA ,  US.
AF INSTRUMENTE
TUTTLINGEN,  GM.
Manufacturer;  
AF INSTRUMENTE
TUTTLINGEN,  GM.
AF INSTRUMENTE
TUTTLINGEN,  GM.
Unregistered Foreign Lister;  
AF INSTRUMENTE
TUTTLINGEN,  GM.
AF OPTIC SOLAIRE
CLAIRVAUX LES LACS,  FR.
Manufacturer;  
AF OPTIC SOLAIRE
CLAIRVAUX LES LACS,  FR.
AFA PLASTICS CORPORATION
AGUADILLA,  PR,  US.
Contract Manufacturer;  
AFA PLASTICS CORPORATION
AGUADILLA,  PR ,  US.

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Last Modified: 29 April 2006
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