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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
SELECT PRODUCTS CO. OF MPLS.
MINNEAPOLIS,  MN,  US.
Initial Importer;  
SELECT PRODUCTS CO. OF MINNEAPOLIS
MINNEAPOLIS,  MN ,  US.
SELECT RESOURCES SENDIRIAN BERHAD
PENANG,  MY.
Manufacturer;  
SELECT RESOURCES SENDIRIAN BERHAD
PENANG,  MY.
SELECT SURGICAL TECHNOLOGIES, INC.
ALPHARETTA,  GA,  US.
Repackager/Relabeller;  
SELECT SURGICAL TECHNOLOGIES, INC.
ALPHARETTA,  GA ,  US.
SELECTIVE IMPORTS CORP.
VERNON,  CA,  US.
Initial Importer;  
SELECTIVE IMPORTS CORP.
VERNON,  CA ,  US.
SELECTIVE MED COMPONENTS, INC.
MOUNT VERNON,  OH,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
SELECTIVE MED COMPONENTS, INC.
MOUNT VERNON,  OH ,  US.
SELECTO ENTERPRISE CORP.
TAIPEI,  TW.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SELECTO ENTERPRISE CORP.
TAIPEI,  TW.
SELF EXPRESSIONS
SHALIMAR,  FL,  US.
Initial Importer;  
SELF EXPRESSIONS
SHALIMAR,  FL ,  US.
SELICOR, INC.
AUSTIN,  TX,  US.
Manufacturer;   Specification Developer;  
SELICOR, INC.
AUSTIN,  TX ,  US.
SELIMA OPTIQUE & ACCESSORIES
NEW YORK,  NY,  US.
Initial Importer;  
SELIMA SALAUN, INC.
NEW YORK,  NY ,  US.
SELLAS MEDIZINISCHE GERATE GMBH
GEVELSBERG, VOGELSANG,  GM.
Unregistered Foreign Lister;   Manufacturer;  
SELLAS MEDIZINISCHE GERATE GMBH
GEVELSBERG, VOGELSANG,  GM.
SEL-LEB MARKETING, INC.
PATERSON,  NJ,  US.
Initial Importer;  
SEL-LEB MARKETING, INC.
PATERSON,  NJ ,  US.
SELLERS UNION CO. LTD.
NINGBO,  CH.
Manufacturer;  
WATCH CLUB, INC.
VERNON,  CA ,  US.
SELLSTROM MFG. CO.
PALATINE,  IL,  US.
Repackager/Relabeller;  
SELLSTROM MFG. CO.
PALATINE,  IL ,  US.
SELSI CO., INC.
MIDLAND PARK,  NJ,  US.
Initial Importer;  
SELSI CO., INC.
MIDLAND PARK,  NJ ,  US.
SELTOM PACIFIC SDN. BHD.
SELANGOR DARUL EHSAN,  MY.
Manufacturer;  
SELTOM PACIFIC SDN. BHD.
SELANGOR DARUL EHSAN,  MY.
SEMMELWEIS
I 20128 MILAN,  IT.
Manufacturer;  
SEMMELWEIS
I 20128 MILAN,  IT.
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
VIENNA,  AU.
Manufacturer;  
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
VIENNA,  AU.
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
WIMPASSING,  AU.
Manufacturer;  
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
VIENNA,  AU.
SEMPERMED KFT.
SOPRON,  HU.
Manufacturer;  
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
VIENNA,  AU.
SEMPERMED USA, INC.
CLEARWATER,  FL,  US.
Initial Importer;  
SEMPERMED USA, INC.
CLEARWATER,  FL ,  US.
SEMPRE BRASIL INC.
MAPLE GROVE,  MN,  US.
Initial Importer;  
SEMPRE BRASIL INC.
MAPLE GROVE,  MN ,  US.
SEMYUNG OPTICAL ELECTRONICS CO., LTD.
DAEJEON,  KS.
Manufacturer;  
SEMYUNG OPTICAL ELECTRONICS CO., LTD.
DAEJEON,  KS.
SEMZA TRADERS
SIALKOT,  PK.
Manufacturer;  
SEMZA TRADERS
SIALKOT,  PK.
SENATOR DESIGNER SRL
CALALZO DI CADORE (BL),  IT.
Manufacturer;  
SENATOR DESIGNER SRL
CALALZO DI CADORE (BL),  IT.
SENDOLINE AB
TABY,  SW.
Manufacturer;  
SENDOLINE AB
TABY,  SW.
SENDX MEDICAL, INC.
CARLSBAD,  CA,  US.
Manufacturer;  
RADIOMETER MEDICAL APS
BRONSHOJ,  DA.
SENECA LABORATORIES, INC.
SOMERVILLE,  MA,  US.
Initial Importer;  
SENECA LABORATORIES, INC.
SOMERVILLE,  MA ,  US.
SENECARE ENTERPRISES INC
BOHEMIA,  NY,  US.
Specification Developer;  
SENECARE ENTERPRISES INC
BOHEMIA,  NY ,  US.
SENERGY MEDICAL GROUP
IRVING,  TX,  US.
Specification Developer;   Repackager/Relabeller;  
SENERGY MEDICAL GROUP
IRVING,  TX ,  US.
SENIOR SYSTEMS TECHNOLOGY, INC.
PALMDALE,  CA,  US.
Contract Manufacturer;  
SENIOR SYSTEMS TECHNOLOGY, INC.
PALMDALE,  CA ,  US.
SENIOR TECHNOLOGIES
LINCOLN,  NE,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
STANLEY SECURITY SOLUTIONS, INC.
INDIANAPOLIS,  IN ,  US.
SENITECH MEDICAL INSTRUMENTS
CARLSBAD,  CA,  US.
Contract Manufacturer;   Manufacturer;  
SENITECH MEDICAL INSTRUMENTS
CARLSBAD,  CA ,  US.
SENITH BIOMED TEORANTA
CO. GALWAY,  EI.
Contract Manufacturer;   Manufacturer;  
XENITH BIOMED
CO. GALWAY,  EI.
SENKO MEDICAL TRADING CO.
TOKYO,  JA.
Manufacturer;  
YOSHIO AOKI
TOKYO,  JA.
SENON FREESTYLE (SINGAPORE)
SINGAPORE,  SN.
Repackager/Relabeller;  
SENON FREESTYLE (SINGAPORE)
SINGAPORE,  SN.
SENORX, INC.
ALISO VIEJO,  CA,  US.
Manufacturer;   Specification Developer;  
SENORX, INC.
ALISO VIEJO,  CA ,  US.
SENSACIONES SA DE CV
BARRIO BELEN, SAN SALVADOR,  ES.
Contract Manufacturer;  
SENSACIONES SA DE CV
BARRIO BELEN, SAN SALVADOR,  ES.
SENSARRAY INFRARED CORP.
BURLINGTON,  MA,  US.
Initial Importer;   Repackager/Relabeller;  
SENSARRAY INFRARED CORP.
BURLINGTON,  MA ,  US.
SENSATIONAL GIFTS LTD
LILBURN,  GA,  US.
Initial Importer;  
SENSATIONAL GIFTS LTD
LILBURN,  GA ,  US.
SENSE TECHNOLOGIES, INC.
SAN ANTONIO,  TX,  US.
Contract Manufacturer;  
SENSE TECHNOLOGIES, INC.
SAN ANTONIO,  TX ,  US.

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Last Modified: 29 April 2006
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