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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
SCA PERSONAL CARE
MOLNDAL, GOTEBORG,  SW.
Manufacturer;   Specification Developer;  
SCA PERSONAL CARE
MUNCHEN-FLUGHAFEN,  GM.
SCA PERSONAL CARE, NORTH AMERICA
DRUMMONDVILLE, QUEBEC,  CA.
Manufacturer;  
SCA PERSONAL CARE
MUNCHEN-FLUGHAFEN,  GM.
SCA PERSONAL CARE, NORTH AMERICA
BOWLING GREEN,  KY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SCA PERSONAL CARE
MUNCHEN-FLUGHAFEN,  GM.
SCALE-TRONIX, INC.
CAROL STREAM,  IL,  US.
Manufacturer;  
SCALE-TRONIX, INC.
CAROL STREAM,  IL ,  US.
SCAN FRAMES APS
CHARLOTTENLUND,  DA.
Manufacturer;  
SCAN FRAMES DIST., INC.
TUCKER,  GA ,  US.
SCAN MEDICAL, LTD.
MIDDLESEX, ENGLAND,  UK.
Unregistered Foreign Lister;  
SCAN MEDICAL, LTD.
MIDDLESEX, ENGLAND,  UK.
SCAN OPTICS PTY., LTD.
THEBARTON, ADELAIDE, S.A.,  AS.
Manufacturer;  
SYNOPTIC SYSTEMS PTY., LTD.
THEBARTON, ADELAIDE, S.A.,  AS.
SCAN TECH MEDICAL, LLC.
COLUMBIA,  SC,  US.
Initial Importer;  
SCAN TECH MEDICAL, LLC.
COLUMBIA,  SC ,  US.
SCANDIA PLASTICS, INC.
SHEBOYGAN,  WI,  US.
Contract Manufacturer;  
SCANDIA PLASTICS, INC.
SHEBOYGAN,  WI ,  US.
SCANDIDOS AB
UPPSALA,  SW.
Specification Developer;  
SCANDIDOS AB
UPPSALA,  SW.
SCANDIMED INTERNATIONAL
GLOSTROP,  DA.
Manufacturer;  
SCANDIMED INTERNATIONAL
GLOSTROP,  DA.
SCANDINAVIAN CONSULTING, INC.
PHOENIZ,  AZ,  US.
Initial Importer;  
SCANDINAVIAN CONSULTING, INC.
PHOENIX,  AZ ,  US.
SCANDINAVIAN EYEWEAR AB
JONKOPING,  SW.
Foreign Exporter;   Manufacturer;  
SCANDINAVIAN EYEWEAR AB
JONKOPING,  SW.
SCANDINAVIAN FORMULAS, INC.
SELLERSVILLE,  PA,  US.
Initial Importer;   Manufacturer;  
SCANDINAVIAN FORMULAS, INC.
SELLERSVILLE,  PA ,  US.
SCANDINAVIAN GENE SYNTHESIS AB
KOPING,  SW.
Manufacturer;  
SCANDINAVIAN GENE SYNTHESIS AB
KOPING,  SW.
SCANDINAVIAN HEALTH LTD.
TAOYUAN,  TW.
Manufacturer;   Specification Developer;  
SCANDINAVIAN HEALTH LTD.
TAOYUAN,  TW.
SCANDINAVIAN MOBILITY
BRONDBY,  SW.
Unregistered Foreign Lister;  
SCANDINAVIAN MOBILITY
BRONDBY,  SW.
SCANDITRONIX WELLHOFER AB
UPPSALA,  SW.
Manufacturer;  
SCANDITRONIX WELLHOFER AB
UPPSALA,  SW.
SCANDITRONIX WELLHOFER NORTH AMERICA
BARTLETT,  TN,  US.
Initial Importer;  
WELLHOFER DOSIMETRIE
SCHWARZENBRUCK,  GM.
SCANDIUS BIOMEDICAL, INC.
LITTLETON,  MA,  US.
Manufacturer;  
SCANDIUS BIOMEDICAL, INC.
LITTLETON,  MA ,  US.
SCANDMED AB
STOCKHOLM,  SW.
Manufacturer;  
SCANDMED
DJURSHOLM,  SW.
SCANLAB INC
CLEVELAND,  OH,  US.
Initial Importer;  
SCANLAB INC
CLEVELAND,  OH ,  US.
SCANLAN INTERNATIONAL, INC.
ST PAUL,  MN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
SCANLAN INTERNATIONAL, INC.
ST PAUL,  MN ,  US.
SCANMED
DJURSHOLM,  SW.
Unregistered Foreign Lister;  
SCANMED
DJURSHOLM,  SW.
SCAN-MED, INC.
PORTER CORNERS,  NY,  US.
Initial Importer;  
SCAN-MED, INC.
PORTER CORNERS,  NY ,  US.
SCANNEX, INC.
MARGATE,  FL,  US.
Manufacturer;  
HORIZONS RESEARCH LABORATORIES, INC.
MARGATE,  FL ,  US.
SCANTEK MEDICAL, INC.
CEDAR KNOLLS,  NJ,  US.
Manufacturer;  
SCANTEK MEDICAL, INC.
CEDAR KNOLLS,  NJ ,  US.
SCANTIBODIES LABORATORY, INC.
SANTEE,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SCANTIBODIES LABORATORY, INC.
SANTEE,  CA ,  US.
SCANWELL SYSTEMS
MONTREAL, QC,  CA.
Manufacturer;   Specification Developer;  
SCANWELL SYSTEMS
MONTREAL, QC,  CA.
SCAPA INC. (DBA FOR ACUTEK INTL.)
INGLEWOOD,  CA,  US.
Manufacturer;  
SCAPA, INC.
INGLEWOOD,  CA ,  US.
SCAPA TAPES NORTH AMERICA
RENFREW, ONTORIO,  CA.
Manufacturer;  
SCAPA NORTH AMERICA
WINDSOR,  CT ,  US.
SCARTH
WANCHAI,  HK.
Unregistered Foreign Lister;  
SCARTH
WANCHAI,  HK.
SCC COMPANY LTD.
CHAIWAN, HONG KONG,  CH.
Foreign Exporter;   Manufacturer;  
PHARMERA GOTHIA PHARMACEUTICAL AB
GOTEBORG,  SW.
SCC SOFT COMPUTER
PALM HARBOR,  FL,  US.
Manufacturer;  
SCC SOFT COMPUTER
PALM HARBOR,  FL ,  US.
SCENAR TRAINING CENTER
DALLAS,  TX,  US.
Manufacturer;  
SCENAR TRAINING CENTER
CHELTENHAM,  UK.
SCENARTRONICS USA LLC
GRAND RAPIDS,  MI,  US.
Initial Importer;  
SCENARTRONICS USA LLC
GRAND RAPIDS,  MI ,  US.
SCEYE AB
BORAS,  SW.
Foreign Exporter;   Manufacturer;  
SCEYE AB
BORAS,  SW.
SCHAAN HEALTHCARE PRODUCTS, INC.
SASKATOON,SASKATCHEWAN,  CA.
Unregistered Foreign Lister;  
SCHAAN HEALTHCARE PRODUCTS, INC.
SASKATOON,SASKATCHEWAN,  CA.
SCHAD MEDICAL INSTRUMENTS GMBH
NEUHAUSEN OB ECK,  GM.
Repackager/Relabeller;  
SCHAD MEDICAL INSTRUMENTS GMBH
NEUHAUSEN OB ECK,  GM.
SCHAEFER BROS., INC.
LISLE,  IL,  US.
Contract Manufacturer;  
TIMOTHY K. BYRNE
LISLE,  IL ,  US.

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Last Modified: 29 April 2006
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