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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
SENSE TECHNOLOGY, INC.
MURRYSVILLE,  PA,  US.
Manufacturer;   Specification Developer;  
SENSE TECHNOLOGY, INC.
MURRYSVILLE,  PA ,  US.
SENSI MEDICAL CORP.
AVENTURA,  FL,  US.
Initial Importer;  
SENSI MEDICAL CORP.
AVENTURA,  FL ,  US.
SENSIBLE HEALTHCARE PRODUCTS, INC.
LUTZ,  FL,  US.
Initial Importer;  
SENSIBLE HEALTHCARE PRODUCTS, INC.
LUTZ,  FL ,  US.
SENSIDYNE, INC.
CLEARWATER,  FL,  US.
Manufacturer;  
SENSIDYNE, INC.
CLEARWATER,  FL ,  US.
SENSIQUEST, INC.
DICKSON CITY,  PA,  US.
Specification Developer;  
SENSIQUEST, INC.
DICKSON CITY,  PA ,  US.
SENSLAB GESELLSCHAFT ZUR ENTWICKLUNG UND HERSTELLU
LEIPZIG,  GM.
Manufacturer;  
SENSLAB GESELLSCHAFT ZUR ENTWICKLUNG UND HERSTELLU
LEIPZIG,  GM.
SENSOMOTORIC INSTRUMENTS, INC.
NEEDHAM,  MA,  US.
Manufacturer;  
SENSOMOTORIC INSTRUMENTS, INC.
NEEDHAM,  MA ,  US.
SENSONICS, INC.
HADDON HEIGHTS,  NJ,  US.
Initial Importer;  
SENSONICS, INC.
HADDON HEIGHTS,  NJ ,  US.
SENSOR DYNAMICS, INC.
FREMONT,  CA,  US.
Specification Developer;  
SENSOR DYNAMICS, INC.
FREMONT,  CA ,  US.
SENSOR HEALTH PRODUCTS, INC.
CAMBRIDGE, ONTARIO,  CA.
Repackager/Relabeller;  
SENSOR HEALTH PRODUCTS, INC.
CAMBRIDGE, ONTARIO,  CA.
SENSOR TECHNOLOGY AND DEVICES LIMITED
BELFAST, NORTHERN IRELAND,  UK.
Contract Manufacturer;   Manufacturer;  
SENSOR TECHNOLOGY AND DEVICES LIMITED
BELFAST, NORTHERN IRELAND,  UK.
SENSORONICS
MURRIETA,  CA,  US.
Repackager/Relabeller;  
SENSORONICS
MURRIETA,  CA ,  US.
SENSORS ELECTRO OPTICS
SALINE,  MI,  US.
Manufacturer;  
SENSORS ELECTRO OPTICS
SALINE,  MI ,  US.
SENSORY ARTS & SCIENCE, LLC
KING OF PRUSSIA,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
SENSORY ARTS & SCIENCE, LLC
KING OF PRUSSIA,  PA ,  US.
SENSOURCE GLOBAL SOURCING
MILFORD,  OH,  US.
Initial Importer;  
SENSOURCE GLOBAL SOURCING
MILFORD,  OH ,  US.
SENTEC AG
THERWIL,  SZ.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
SENTEC AG
THERWIL,  SZ.
SENTECH KOREA CORP.
GOYANG-SI, KYEONGGI-DO,  KS.
Manufacturer;  
SENTECH KOREA CORP.
GOYANG-SI, KYEONGGI-DO,  KS.
SENTECH MEDICAL SYSTEMS, INC.
CORAL SPRINGS,  FL,  US.
Initial Importer;   Manufacturer;  
SENTECH MEDICAL SYSTEMS, INC.
CORAL SPRINGS,  FL ,  US.
SENTINEL CH. SRL
MILANO,  IT.
Manufacturer;  
SENTINEL CH. SRL
MILANO,  IT.
SENTINEL CONSUMER PRODUCTS, INC.
CLEARFIELD,  UT,  US.
Repackager/Relabeller;  
SENTINEL CONSUMER PRODUCTS, INC.
MENTOR,  OH ,  US.
SENTRON EUROPE BV
AC RODEN,  NL.
Unregistered Foreign Lister;  
SENTRON EUROPE BV
AC RODEN,  NL.
SENTRY MEDICAL PRODUCTS, INC.
GREEN BAY,  WI,  US.
Initial Importer;  
SENTRY MEDICAL PRODUCTS, INC.
GREEN BAY,  WI ,  US.
SENZPAK SDN BHD
SENAI, JOHOR,  MY.
Manufacturer;  
SENZPAK SDN BHD
SENAI, JOHOR,  MY.
SEO IN CORPORATION
SEOUL,  KS.
Manufacturer;  
SEO IN CORPORATION
SEOUL,  KS.
SEO JEON CO., LTD.
SEOUL,  KS.
Manufacturer;  
SEO JEON CO., LTD.
SEOUL,  KS.
SEO WON OPTICAL CO.
DALSEOGU, DAEGU,  KS.
Manufacturer;  
SEO WON OPTICAL CO.
DALSEOGU, DAEGU,  KS.
SEO-IL CHEMICAL CO., LTD.
HWA SUNG, KYUNGGI-DO,  KS.
Manufacturer;  
SEO-IL CHEMICAL CO., LTD.
HWA SUNG, KYUNGGI-DO,  KS.
SEOUL OPTICAL CO., LTD.
INCHON,  KS.
Manufacturer;  
SEOUL OPTICAL CO., LTD.
INCHON,  KS.
SEOUNG WOO OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
SEOUNG WOO OPTICAL CO.
DAEGU,  KS.
SEOWHA CORP.
DAEGU,  KS.
Manufacturer;  
SEOWHA CORP.
DAEGU,  KS.
SEPAL REPRODUCTIVE DEVICES, INC.
SUDBURY,  MA,  US.
Initial Importer;  
SEPAL REPRODUCTIVE DEVICES, INC.
SUDBURY,  MA ,  US.
SEPARATION TECHNOLOGY, INC.
ALTAMONTE SPRINGS,  FL,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
FISHER SCIENTIFIC CO., LLC.
PITTSBURGH,  PA ,  US.
SEPTA CORP.
MASON,  NH,  US.
Manufacturer;  
SEPTA CORP.
MASON,  NH ,  US.
SEPTODONT
CEDEX,  FR.
Manufacturer;  
SEPTODONT
CEDEX,  FR.
SEPTODONT HEALTHCARE INDIA PRIVATE LTD.
VILLAGE-NAVADE, TALUKA-PANVEL,  IN.
Manufacturer;  
SEPTODONT
CEDEX,  FR.
SEPTODONT, INC.
NEW CASTLE,  DE,  US.
Initial Importer;  
SEPTODONT, INC.
NEW CASTLE,  DE ,  US.
SEPULVEDA MULTI DENTAL
RIO PIEDRAS,  PR,  US.
Initial Importer;  
SEPULVEDA MULTI DENTAL
RIO PIEDRAS,  PR ,  US.
SEQUAL TECHNOLOGIES, INC.
SAN DIEGO,  CA,  US.
Manufacturer;   Specification Developer;  
SEQUAL TECHNOLOGIES, INC.
SAN DIEGO,  CA ,  US.
SEQUEL SPECIAL PRODUCTS, LLC.
WATERBURY,  CT,  US.
Contract Manufacturer;  
SEQUEL SPECIAL PRODUCTS, LLC.
WATERBURY,  CT ,  US.
SEQUOIA DENTAL STUDIO, LLC
WESTMONT,  IL,  US.
Initial Importer;  
SEQUOIA DENTAL STUDIO, LLC
WESTMONT,  IL ,  US.

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Last Modified: 29 April 2006
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