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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
EVERTOP ELECTRONICS, LTD.
KOWLOON,  HK.
Unregistered Foreign Lister;  
EVERTOP ELECTRONICS, LTD.
KOWLOON,  HK.
EVERWEST INTERNATIONAL CORP
IRWINDALE,  CA,  US.
Initial Importer;  
EVERWEST INTERNATIONAL CORP
IRWINDALE,  CA ,  US.
EVERY MORNING CO., LTD.
TAIPEI,  TW.
Manufacturer;  
EVERY MORNING CO., LTD.
TAIPEI,  TW.
EVERYBYTE, LLC
THOUSAND OAKS,  CA,  US.
Manufacturer;   Specification Developer;  
EVERYBYTE, LLC
THOUSAND OAKS,  CA ,  US.
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
SHEN KENG HSIANG,TAIPEI HSIEN,  TW.
Manufacturer;  
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
SHEN KENG HSIANG,TAIPEI HSIEN,  TW.
EVIDENT DENTAL CO. LTD.
LONDON,  UK.
Unregistered Foreign Lister;  
EVIDENT DENTAL CO. LTD.
LONDON,  UK.
E-VISION SYSTEMS, INC.
SANTA BARBARA,  CA,  US.
Initial Importer;  
E-VISION SYSTEMS, INC.
SANTA BARBARA,  CA ,  US.
EVIT LABS, INC.
MCCLELLAN,  CA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
EVIT LABS, INC.
MCCLELLAN,  CA ,  US.
EVITA INTL., LTD.
TAIPEI,  TW.
Manufacturer;  
EVITA INTL., LTD.
TAIPEI,  TW.
EVKO DENTAL, INC.
TAIPEI,  TW.
Manufacturer;  
DHEF INC.
TAIPEI,  TW.
EVOLUTION DIAGNOSTIC LABORATORY, INC.
LAKEWOOD,  NJ,  US.
Manufacturer;  
EVOLUTION DIAGNOSTIC LABORATORY, INC.
LAKEWOOD,  NJ ,  US.
EVOLUTION TECHNOLOGIES, INC.
PORT COQUITLAM BC,  CA.
Foreign Exporter;  
EVOLUTION TECHNOLOGIES, INC.
PORT COQUITLAM, BC,  CA.
EVOLUTIONEYES EYEWEAR LLC.
SMITHFIELD,  RI,  US.
Initial Importer;   Repackager/Relabeller;  
EVOLUTIONEYES EYEWEAR LLC.
SMITHFIELD,  RI ,  US.
EVOLUTIS
BRIENNON,  FR.
Contract Manufacturer;  
EVOLUTIS
BRIENNON,  FR.
EVOLUZIONE S.R.L.
FLERO, BRESCIA,  IT.
Manufacturer;  
EVOLUZIONE S.R.L.
FLERO, BRESCIA,  IT.
EVOLVED DIGITAL SOLUTIONS
BRENTWOOD,  TN,  US.
Manufacturer;  
EVOLVED DIGITAL SOLUTIONS
BRENTWOOD,  TN ,  US.
EWALD BACHER GMBH
RIETHEIM-WEILHEIM,  GM.
Manufacturer;  
EWALD BACHER GMBH
RIETHEIM-WEILHEIM,  GM.
EWELL EQUIPMENT CO., INC.
LUFKIN,  TX,  US.
Initial Importer;  
EWELL EQUIPMENT CO., INC.
LUFKIN,  TX ,  US.
E-WHA INTERNATIONAL, INC.LTD.
GUNPO-SI, KYUNGGI-DO,  KS.
Foreign Exporter;   Manufacturer;  
E-WHA INTERNATIONAL, INC.LTD.
SEOUL,  KS.
EWIG INDUSTRIES MACAO COMMERCIAL OFFSHORE LTD.
MACAO,  CH.
Manufacturer;  
EWIG INDUSTRIES MACAO COMMERCIAL OFFSHORE LTD.
MACAO,  CH.
EX AM, LTD.
LOS ANGELES,  CA,  US.
Initial Importer;  
EX AM, LTD.
LOS ANGELES,  CA ,  US.
EXACT SCIENCES CORP.
MARLBOROUGH,  MA,  US.
Specification Developer;  
EXACT SCIENCES CORP.
MARLBOROUGH,  MA ,  US.
EXACTA DENTAL PRODUCTS, INC.
AUBURN HILLS,  MI,  US.
Initial Importer;  
EXACTA DENTAL PRODUCTS, INC.
AUBURN HILLS,  MI ,  US.
EXACTA DENTAL PRODUCTS, INC.
CLINTON TWP,  MI,  US.
Repackager/Relabeller;  
EXACTA DENTAL PRODUCTS, INC.
CLINTON TOWNSHIP,  MI ,  US.
EXACTA MACHINE, INC.
WICHITA,  KS,  US.
Contract Manufacturer;  
EXACTA MACHINE, INC.
WICHITA,  KS ,  US.
EXACTA SWEATERS, INC.
MASPETH,  NY,  US.
Initial Importer;  
EXACTA SWEATERS, INC.
MASPETH,  NY ,  US.
EXACTECH, INC.
GAINESVILLE,  FL,  US.
Initial Importer;   Manufacturer;  
EXACTECH, INC.
GAINESVILLE,  FL ,  US.
EXAKT APPARATEBAU GMBH & CO. KG
NORDERSTEDT,  GM.
Manufacturer;  
EXAKT APPARATEBAU GMBH & CO. KG
NORDERSTEDT,  GM.
EXAKT TECHNOLOGIES, INC.
OKLAHOMA CITY,  OK,  US.
Initial Importer;   Manufacturer;  
EXAKT TECHNOLOGIES, INC.
OKLAHOMA CITY,  OK ,  US.
EXAMGLOW USA, INC.
LIVONIA,  MI,  US.
Initial Importer;  
EXAMGLOW USA, INC.
LIVONIA,  MI ,  US.
EXAMTEX MANUFACTURERS
KUALA LUMPUR,  MY.
Manufacturer;  
EXAMTEX MANUFACTURERS
KUALA LUMPUR,  MY.
EXAVIER MFG. LTD.
BELLEVILLE, ONTARIO,  CA.
Unregistered Foreign Lister;  
EXAVIER MFG. LTD.
BELLEVILLE, ONTARIO,  CA.
EXAXOL CHEMICAL CORP.
CLEARWATER,  FL,  US.
Manufacturer;  
EXAXOL CHEMICAL CORP.
CLEARWATER,  FL ,  US.
EXCALIBUR ENGINEERING
LOGAN,  UT,  US.
Contract Manufacturer;   Specification Developer;  
EXCALIBUR ENGINEERING
LOGAN,  UT ,  US.
EXCALIBUR LAB SPECIALISTS, INC.
MINDEN,  NV,  US.
Initial Importer;   Repackager/Relabeller;  
EXCALIBUR LAB SPECIALISTS, INC.
MINDEN,  NV ,  US.
EXCEL DENTAL LAB CO., LTD.
BANGKOK,  TH.
Manufacturer;  
EXCEL DENTAL LAB CO., LTD.
BANGKOK,  TH.
EXCEL DENTAL LAB INC.
GALVESTON,  TX,  US.
Initial Importer;  
EXCEL DENTAL LAB INC.
GALVESTON,  TX ,  US.
EXCEL GLOVES & SAFETY SUPPLIES, INC.
FIFE,  WA,  US.
Initial Importer;  
EXCEL GLOVES & SAFETY SUPPLIES, INC.
FIFE,  WA ,  US.
EXCEL INTL. LTD.
MOUNT PROSPECT,  IL,  US.
Initial Importer;   Repackager/Relabeller;  
EXCEL INTL. LTD.
MOUNT PROSPECT,  IL ,  US.
EXCEL LABS
OSSEO,  MN,  US.
Contract Manufacturer;  
EXCEL LABS
OSSEO,  MN ,  US.

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Last Modified: 29 April 2006
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