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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
SEQUOIA EYEWEAR LTD.
CHEUNG SHA WAN, KOWLOON,  HK.
Manufacturer;  
SEQUOIA EYEWEAR LTD.
CHEUNG SHA WAN, KOWLOON,  HK.
SERACARE BIOSERVICES
GAITHERSBURG,  MD,  US.
Manufacturer;  
SERACARE LIFE SCIENCES, INC
OCEANSIDE,  CA ,  US.
SERACARE LIFE SCIENCES, INC.
OCEANSIDE,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SERACARE LIFE SCIENCES, INC
OCEANSIDE,  CA ,  US.
SERADYN INC.
INDIANAPOLIS,  IN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
FISHER SCIENTIFIC CO., LLC.
PITTSBURGH,  PA ,  US.
SERAG-WIESSNER KG
NAILA, BAVARIA,  GM.
Manufacturer;  
SERAG-WIESSNER KG
NAILA, BAVARIA,  GM.
SERASTONE USA, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
SERASTONE USA, INC.
LOS ANGELES,  CA ,  US.
SERENGETI EYEWEAR, INC.
OVERLAND PARK,  KS,  US.
Initial Importer;  
BUSHNELL PERFORMANCE OPTICS
OVERLAND PARK,  KS ,  US.
SERES ENTERPRISE CO., LTD.
TAIPEI,  TW.
Manufacturer;  
SERES ENTERPRISE CO., LTD.
TAIPEI,  TW.
SERIM RESEARCH CORP.
ELKHART,  IN,  US.
Manufacturer;  
SERIM RESEARCH CORP.
ELKHART,  IN ,  US.
SERITEX, INC.
EAST RUTHERFORD,  NJ,  US.
Initial Importer;  
SERITEX, INC.
EAST RUTHERFORD,  NJ ,  US.
SERO A/S
BILLINSTAD,  NO.
Manufacturer;  
SERO A/S
BILLINSTAD,  NO.
SEROLOGICAL RESEARCH INST.
RICHMOND,  CA,  US.
Repackager/Relabeller;  
SEROLOGICAL RESEARCH INST.
RICHMOND,  CA ,  US.
SEROLOGICALS, INC.
LIVINGSTON,  UK.
Manufacturer;  
SEROLOGICALS CORPORATION
NORCROSS,  GA ,  US.
SERONO, INC.
ROCKLAND,  MA,  US.
Initial Importer;   Specification Developer;  
SERONO, INC.
ROCKLAND,  MA ,  US.
SEROTEC, LTD.
KIDLINGTON, OXFORD,  UK.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SEROTEC, LTD.
KIDLINGTON, OXFORD,  UK.
SERRAL, S.A. DE C.V.
MEXICO CITY; D.F., C.P.,  MX.
Manufacturer;   Specification Developer;  
SERRAL, S.A. DE C.V.
MEXICO CITY; D.F., C.P.,  MX.
SERRAO OPTICAL INTL., INC.
MIAMI,  FL,  US.
Initial Importer;  
SERRAO OPTICAL INTL., INC.
MIAMI,  FL ,  US.
SERTECH AMERICA CORP.
MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
SERTECH AMERICA CORP.
MIAMI,  FL ,  US.
SERVALL CORP.
ANDERSON,  SC,  US.
Manufacturer;  
SERVALL CORP.
ANDERSON,  SC ,  US.
SERV-A-PURE COMPANY
BAY CITY,  MI,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
SERV-A-PURE COMPANY
BAY CITY,  MI ,  US.
SERVICE CARE, INC.
HUNTINGTON WOODS,  MI,  US.
Initial Importer;  
SERVICE CARE, INC.
HUNTINGTON WOODS,  MI ,  US.
SERVICE GRAPHICS, INC.
INDIANAPOLIS,  IN,  US.
Contract Manufacturer;  
SERVICE GRAPHICS, INC.
INDIANAPOLIS,  IN ,  US.
SERVICE MEDICAL SUPPLY, INC.
LOCKLAND,  OH,  US.
Initial Importer;  
SERVICE MEDICAL SUPPLY, INC.
LOCKLAND,  OH ,  US.
SERVICES INDUSTRIELS SAVARIA, INC.
LAVAL, QUEBEC,  CA.
Manufacturer;  
SERVICES INDUSTRIELS SAVARIA, INC.
LAVAL, QUEBEC,  CA.
SERVICIOS DE ENSAMBLE INTERNACIONALES S.A. DE C.V.
JUAREZ CHIHUAHUA,  MX.
Contract Manufacturer;  
SERVICIOS DE ENSAMBLE INTERNACIONALES S.A. DE C.V.
JUAREZ CHIHUAHUA,  MX.
SERVICIOS DE MANUFACTURA INTERNACIONAL, S.A. DE C.
JUAREZ,  MX.
Contract Manufacturer;  
QUALITY MANUFACTURING SERVICES
EL PASO,  TX ,  US.
SERVICIOS INDUSTRIALES NOVA/LINK, S.A. DE C.V.
MATAMOROS, TAMPS,  MX.
Contract Manufacturer;  
NOVA LINK, INC.
BROWNSVILLE,  TX ,  US.
SERVICOM SERVICES SDN BHD
KUALA LUMPAR,  MY.
Repackager/Relabeller;  
SERVICOM SERVICES SDN BHD
KUALA LUMPAR,  MY.
SERVISHARP, INC.
MASSILLON,  OH,  US.
Manufacturer;  
SERVISHARP, INC.
MASSILLON,  OH ,  US.
SERVI-TECH, INC.
SALT LAKE CITY,  UT,  US.
Initial Importer;  
SERVI-TECH, INC.
SALT LAKE CITY,  UT ,  US.
SERVIZI MEDICO ESTETICI ITALINAI SRL.
CASALE MONFERRATO (AL),  IT.
Manufacturer;  
SERVIZI MEDICO ESTETICI ITALINAI SRL.
CASALE MONFERRATO (AL),  IT.
SERVO DENTAL USA, INC.
NORTHBROOK,  IL,  US.
Initial Importer;  
SERVO DENTAL USA, INC.
NORTHBROOK,  IL ,  US.
SERVO-DENTAL, RADEMACHER & DORKEN OHG
HAGEN-HALDEN,  GM.
Manufacturer;  
SERVO-DENTAL, RADEMACHER & DORKEN OHG
HAGEN-HALDEN,  GM.
SERVO-MED INDUSTRIES PVT. LTD.
ANDHERI,MUMBAI, BOMBAY,  IN.
Manufacturer;  
SERVO-MED INDUSTRIES PVT. LTD.
ANDHERI,MUMBAI, BOMBAY,  IN.
SERVOX AG
TROISDORF,  GM.
Manufacturer;   Remanufacturer;  
SERVOX AG
TROISDORF,  GM.
SETLAZ
CHANGHUA,  TW.
Manufacturer;  
SETLAZ
CHANGHUA,  TW.
SETO CORP.
FUNABASHI CHIBA,  JA.
Manufacturer;  
SETO CORP.
FUNABASHI CHIBA,  JA.
SETO FACTORY OF ASAHI INTECC CO., LTD.
SETO, AICHI,  JA.
Manufacturer;   Specification Developer;   Contract Sterilizer;  
ASAHI INTECC CO., LTD.
NAGOYA, AICHI,  JA.
SEVEN HARVEST INTL. IMPORT & EXPORT
KOKOMO,  IN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SEVEN HARVEST INTL. IMPORT & EXPORT
KOKOMO,  IN ,  US.
SEVEN PYRAMID ENT CO., LTD.
TAIPEI,  TW.
Manufacturer;  
SEVEN PYRAMID ENT CO., LTD.
TAIPEI,  TW.

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Last Modified: 29 April 2006
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