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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
SITCA, INC.
ANN ARBOR,  MI,  US.
Manufacturer;   Specification Developer;  
SITCA, INC.
ANN ARBOR,  MI ,  US.
SITCER CORP.
GARWOOD,  NJ,  US.
Initial Importer;  
SITCER CORP.
GARWOOD,  NJ ,  US.
SITESELECT MEDICAL TECHNOLOGIES, LTD
SAN FRANCISCO,  CA,  US.
Specification Developer;  
SITESELECT MEDICAL TECHNOLOGIES, LTD
SAN FRANCISCO,  CA ,  US.
SIU FUNG PLASTIC TOYS FACTORY LTD.
NEW TERRITORIES,  HK.
Unregistered Foreign Lister;  
SIU FUNG PLASTIC TOYS FACTORY LTD.
NEW TERRITORIES,  HK.
SIUDON LTD.
HAIFA,  IS.
Unregistered Foreign Lister;  
SIUDON LTD.
HAIFA,  IS.
SIUI AMERICA, INC.
SANTA CLARA,  CA,  US.
Initial Importer;  
SIUI AMERICA, INC.
SANTA CLARA,  CA ,  US.
SIX-O, LTD.
RAPID CITY,  SD,  US.
Specification Developer;  
SIX-O, LTD.
RAPID CITY,  SD ,  US.
SIXT EYEWEAR
FRIEDRICH SCHMIDT-PLATZ 4/5,  AU.
Unregistered Foreign Lister;  
SIXT EYEWEAR
FRIEDRICH SCHMIDT-PLATZ 4/5,  AU.
SIZMAN SURGICO
SIALKOT,  PK.
Manufacturer;  
SIZMAN SURGICO
SIALKOT,  PK.
SJ HARVEST INTL. (THAILAND) CO., LTD.
RAYONG,  TH.
Manufacturer;  
SJ HARVEST INTL. (THAILAND) CO., LTD.
RAYONG,  TH.
SJ MEDICAL PRODUCTS (M) SDN BHD
KLANG, SELANGOR,  MY.
Manufacturer;  
SJ MEDICAL PRODUCTS (M) SDN BHD
KLANG, SELANGOR,  MY.
SJIN KOREA
ANYANG, GYEONGGI-DO,  KS.
Manufacturer;  
SJIN KOREA
ANYANG, GYEONGGI-DO,  KS.
SJS SPECIALTY CO., INC.
MANALAPAN,  NJ,  US.
Initial Importer;  
SJS SPECIALTY CO., INC.
MANALAPAN,  NJ ,  US.
SJS X-RAY CORP.
MT. PLEASANT,  SC,  US.

SJS X-RAY CORP.
MT. PLEASANT,  SC ,  US.
SKAGA MADE IN SWEDEN
ENGLEWOOD,  CO,  US.
Initial Importer;  
SCORE INTL., INC.
ENGLEWOOD,  CO ,  US.
SKAGEN DESIGNS, LTD.
RENO,  NV,  US.
Initial Importer;   Specification Developer;  
SKAGEN DESIGNS, LTD.
RENO,  NV ,  US.
SKAL DENTAL STUDIO
ERIE,  PA,  US.
Initial Importer;  
SKAL DENTAL STUDIO
ERIE,  PA ,  US.
SKAN INSTRUMENTS, DIV. MEDX, INC.
ARLINGTON HEIGHTS,  IL,  US.
Manufacturer;  
MEDX, INC.
ARLINGTON HEIGHTS,  IL ,  US.
SKANDIALIFE MANUFACTURING
RAPLAMAA,  EN.
Contract Manufacturer;   Manufacturer;  
SYBARITIC, INC.
BLOOMINGTON,  MN ,  US.
SKEDCO, INC.
PORTLAND,  OR,  US.
Manufacturer;  
SKEDCO, INC.
PORTLAND,  OR ,  US.
SKELETAL KINETICS, LLC
CUPERTINO,  CA,  US.
Manufacturer;   Specification Developer;  
SKELETAL KINETICS, LLC
CUPERTINO,  CA ,  US.
SKET IND.
SIALKOT, PUNJAB,  PK.
Manufacturer;  
SKET IND.
SIALKOT, PUNJAB,  PK.
SKIL-CARE CORP.
YONKERS,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SKIL-CARE CORP.
YONKERS,  NY ,  US.
SKILL TECHNOLOGIES, INC.
PHOENIX,  AZ,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SKILL TECHNOLOGIES, INC.
PHOENIX,  AZ ,  US.
SKILLBUILDER POSITIONING DEVICES, INC.
WADSWORTH,  OH,  US.
Contract Manufacturer;  
SKILLBUILDER POSITIONING DEVICES, INC.
WADSWORTH,  OH ,  US.
SKILLS, INC.
SEATTLE,  WA,  US.
Contract Manufacturer;  
SKILLS, INC.
SEATTLE,  WA ,  US.
SKILLTEK INDUSTRIES, INC.
TAIPEI,  TW.
Manufacturer;  
SKILLTEK INDUSTRIES, INC.
TAIPEI,  TW.
SKIN CARE CONSULTANTS
SCARBOROUGH,  CA.
Unregistered Foreign Lister;  
SKIN CARE CONSULTANTS
SCARBOROUGH,  CA.
SKIN DEEP, INC.
PHILADELPHIA,  PA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SKIN DEEP, INC.
PHILADELPHIA,  PA ,  US.
SKIN PERFECTION, INC.
BRAWNTON, ONTARIO,  CA.
Unregistered Foreign Lister;  
SKIN PERFECTION, INC.
BRAWNTON, ONTARIO,  CA.
SKIN RECOVERY CENTER, INC.
HOUSTON,  TX,  US.
Manufacturer;  
SKIN RECOVERY CENTER, INC.
HOUSTON,  TX ,  US.
SKIN TECHNOLOGIES, INC.
FREDERICKSBURG,  VA,  US.
Contract Manufacturer;   Manufacturer;  
SKIN TECHNOLOGIES, INC.
FREDERICKSBURG,  VA ,  US.
SKINCARE SPECIALTY SYSTEMS, INC.
MOORESVILLE,  NC,  US.
Initial Importer;  
SKINCARE SPECIALTY SYSTEMS, INC.
MOORESVILLE,  NC ,  US.
SKINCARE TECHNOLOGY INC.
CHICAGO,  IL,  US.
Specification Developer;  
SKINCARE TECHNOLOGY INC.
CHICAGO,  IL ,  US.
SKINS USA, LLC
VALENCIA,  CA,  US.
Initial Importer;  
SKINS USA, LLC
VALENCIA,  CA ,  US.
SKINSCIENCE LABS, INC.
NEW YORK,  NY,  US.
Manufacturer;  
SKINSCIENCE LABS, INC.
NEW YORK,  NY ,  US.
SKINSTITCH CORP.
MASSENA,  NY,  US.
Repackager/Relabeller;  
SKINSTITCH CORP.
MASSENA,  NY ,  US.
SKLAR CORP.
WEST CHESTER,  PA,  US.
Initial Importer;   Repackager/Relabeller;  
MEDCO GROUP,INC.
WEST CHESTER,  PA ,  US.
SKLAR STERILE
WEST CHESTER,  PA,  US.
Repackager/Relabeller;  
SKLAR STERILE
WEST CHESTER,  PA ,  US.
SKLR & ASSOCIATES, INC.
DAVIE,  FL,  US.
Initial Importer;  
SKLR & ASSOCIATES, INC.
DAVIE,  FL ,  US.

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Last Modified: 29 April 2006
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