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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
SSL MANUFACTURING LTD.
BANGSAMAK,BANGPAKONG,CHACHOENG,  TH.
Manufacturer;  
SSL INTERNATIONAL, PLC
MANCHESTER,  UK.
SSN MEDICAL PRODUCTS SDN. BHD.
PETALING JAYA, SELANGOR,  MY.
Manufacturer;  
SSN MEDICAL PRODUCTS SDN. BHD.
PETALING JAYA, SELANGOR,  MY.
SSN USA, INC.
LIVONIA,  MI,  US.
Initial Importer;  
EXAMGLOV USA, INC.
LIVONIA,  MI ,  US.
ST CORP. (STAR FASHION)
DAE GU,  KS.
Manufacturer;  
ST CORP. (STAR FASHION)
DAE GU,  KS.
ST. FRANCIS HOSPITAL, INC.
MILWAUKEE,  WI,  US.
Reprocessor of single-use devices;  
WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN
GLENDALE,  WI ,  US.
ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.
SAN CHUNG CITY, TAIPEI HSIEN,  TW.
Manufacturer;  
ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.
SAN CHUNG CITY TAIPEI CITY,  TW.
ST. FRANCIS MEDICAL EQUIPMENT, INC.
WATERBURY,  CT,  US.

ST. FRANCIS MEDICAL EQUIPMENT, INC.
WATERBURY,  CT ,  US.
ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
ALAMEDA,  CA,  US.
Manufacturer;  
ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
ALAMEDA,  CA ,  US.
ST. JOHN AMBULANCE
OTTAWA, ONTARIO,  CA.
Repackager/Relabeller;  
ST. JOHN AMBULANCE
OTTAWA, ONTARIO,  CA.
ST. JOSEPH REGIONAL MEDICAL CENTER
MILWAUKEE,  WI,  US.
Reprocessor of single-use devices;  
WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN
GLENDALE,  WI ,  US.
ST. JOSEPH SURGICAL SUPPLY, INC.
ST. JOSEPH,  MO,  US.

ST. JOSEPH SURGICAL SUPPLY, INC.
ST. JOSEPH,  MO ,  US.
ST. JUDE MEDICAL
MAPLE GROVE,  MN,  US.
Manufacturer;   Specification Developer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL
SYLMAR,  CA,  US.
Initial Importer;   Manufacturer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL AB
JARFALLA,  SW.
Manufacturer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL BRASIL LTDA.
NOVA LIMA, MINAS GERAIS,  BR.
Manufacturer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL, DAIG DIVISION, INC.
MINNETONKA,  MN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL, INC.
ST. HYACINTHE, QUEBEC,  CA.
Manufacturer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL, INC.
MAPLE GROVE,  MN,  US.
Specification Developer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN,  US.
Manufacturer;   Specification Developer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL, INC.
SUNNYVALE,  CA,  US.
Specification Developer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS
ST. PAUL,  MN,  US.
Manufacturer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUDE MEDICAL, PUERTO RICO, B.V.
CAGUAS,  PR,  US.
Manufacturer;  
ST. JUDE MEDICAL, INC.
ST. PAUL,  MN ,  US.
ST. JUSTINE, INC.
TAIPEI,  TW.
Specification Developer;  
ST. JUSTINE, INC.
TAIPEI,  TW.
ST. LOUIS OPHTHALMIC EQUIPMENT CO.
ST. LOUIS,  MO,  US.
Initial Importer;  
ST. LOUIS OPHTHALMIC EQUIPMENT CO.
ST. LOUIS,  MO ,  US.
ST. MICHAEL HOSPITAL, INC.
MILWAUKEE,  WI,  US.
Reprocessor of single-use devices;  
WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN
GLENDALE,  WI ,  US.
ST. PAUL BIOTECH
GARDEN GROVE,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ST. PAUL BIOTECH
GARDEN GROVE,  CA ,  US.
ST. SHINE OPTICAL CO., LTD.
TAIPEI HSIEN,  TW.
Manufacturer;  
ST. SHINE OPTICAL CO., LTD.
TAIPEI HSIEN,  TW.
STA AMI, INC.
CERRITOS,  CA,  US.
Initial Importer;  
STA AMI, INC.
CERRITOS,  CA ,  US.
STAAR SURGICAL AG
NIDAU,  SZ.
Manufacturer;  
STAAR SURGICAL CO.
MONROVIA,  CA ,  US.
STAAR SURGICAL CO.
ALISO VIEJO,  CA,  US.
Manufacturer;  
STAAR SURGICAL CO.
MONROVIA,  CA ,  US.
STAAR SURGICAL CO.
MONROVIA,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
STAAR SURGICAL CO.
MONROVIA,  CA ,  US.
STABLE SURGICAL WORKS
SIALKOT-1,  PK.
Unregistered Foreign Lister;  
STABLE SURGICAL WORKS
SIALKOT-1,  PK.
STADO ENTERPRISES
SANTA ANA,  CA,  US.
Initial Importer;  
STADO ENTERPRISES
SANTA ANA,  CA ,  US.
STAFCO, INC.
BROOKLYN,  NY,  US.
Initial Importer;  
STAFCO, INC.
BROOKLYN,  NY ,  US.
STAFFORD-MILLER IRELAND, LTD.
DUNGARVAN CO., WATERFORD,  EI.
Manufacturer;  
SMITHKLINE BEECHAM CONSUMER HEALTHCARE, L.P.
PITTSBURG,  PA ,  US.
STAFFORD-MILLER LTD.
PLYMOUTH, DEVON,  UK.
Manufacturer;  
SMITHKLINE BEECHAM CONSUMER HEALTHCARE, L.P.
PITTSBURG,  PA ,  US.
STAGO INSTRUMENTS P.A.E. PARISPACE3
GENNEVILLIERS, CEDEX,  FR.
Contract Manufacturer;  
STAGO B.V.
AMSTERDAM,  NL.
STAGO R & D
GENNEVILLIERS,  FR.
Manufacturer;  
DIAGNOSTICA-STAGO
ASNIERES,  FR.
STAIN ENTERPRISES
WELLINGTON, WESTERN CAPE,  SF.
Manufacturer;  
STAIN ENTERPRISES
WELLINGTON, WESTERN CAPE,  SF.
STAINLESS DESIGN CORP.
SAUGERTIES,  NY,  US.
Contract Manufacturer;  
STAINLESS DESIGN CORP.
SAUGERTIES,  NY ,  US.

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Last Modified: 29 April 2006
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