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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
SOLO BAMBINI
SAN MATEO,  CA,  US.
Initial Importer;  
SOLO BAMBINI
SAN MATEO,  CA ,  US.
SOLO CLIP
S. EL MONTE,  CA,  US.
Initial Importer;  
SOLO CLIP
S. EL MONTE,  CA ,  US.
SOLO LABORATORIES, INC.
BELLWOOD,  IL,  US.
Contract Manufacturer;  
SOLO LABORATORIES, INC.
BELLWOOD,  IL ,  US.
SOLOMON TECHNOLOGY LABS
MARICOPA,  AZ,  US.
Manufacturer;  
SOLOMON TECHNOLOGY LABS
MARICOPA,  AZ ,  US.
SOLON MANUFACTURING COMPANY
RHINELANDER,  WI,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
SOLON MANUFACTURING COMPANY
SKOWHEGAN,  ME ,  US.
SOLOPACIFIC CO.
BENICIA,  CA,  US.
Initial Importer;  
SOLOPACIFIC CO.
BENICIA,  CA ,  US.
SOLO-SLED, LLC.
CHATTANOOGA,  TN,  US.
Initial Importer;  
SOLO-SLED, LLC.
CHATTANOOGA,  TN ,  US.
SO-LOW ENVIROMENTAL EQUIP CO., INC.
CINCINNATI,  OH,  US.
Manufacturer;  
SO-LOW ENVIROMENTAL EQUIP CO., INC.
CINCINNATI,  OH ,  US.
SOLSTAR PRODUKTIONS GMBH
SPITTAL/DRAU,  AU.
Manufacturer;  
SOLSTAR PRODUKTIONS GMBH
SPITTAL/DRAU,  AU.
SOLSTICE CORP.
PORTLAND,  ME,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
SOLSTICE CORP.
PORTLAND,  ME ,  US.
SOLTECH USA, INC.
SOUTH JACKSONVILLE,  IL,  US.
Initial Importer;  
SOLTECH USA, INC.
SOUTH JACKSONVILLE,  IL ,  US.
SOLUAIDS RUBBER INDUSTRIES SDN BHD
KUALA LUMPUR W P,  MY.
Manufacturer;  
SOLUAIDS RUBBER INDUSTRIES SDN BHD
KLANG S G,  MY.
SOLUBLE PRODUCTS CO., L.P.
LAKEWOOD,  NJ,  US.
Manufacturer;  
SOLUBLE PRODUCTS CO., L.P.
LAKEWOOD,  NJ ,  US.
SOLUTIONS INC. (S) PRIVATE LIMITED
SINGAPORE,  SN.
Foreign Exporter;  
SOLUTIONS INC. (S) PRIVATE LIMITED
SINGAPORE,  SN.
SOLUTIONS, INC.
LOUIEVILLE,  KY,  US.
Initial Importer;  
SOLUTIONS, INC.
LOUISVILLE,  KY ,  US.
SOM OCCHIALI SRL
CALALZO DI CADORE,  IT.
Manufacturer;  
SOM OCCHIALI SRL
CALALZO DI CADORE,  IT.
SOMA INTERNATIONAL LTD.
KOWLOON,  HK.
Remanufacturer;   Specification Developer;  
SOMA INTERNATIONAL LTD.
KOWLOON,  HK.
SOMANETICS CORP.
TROY,  MI,  US.
Manufacturer;   Remanufacturer;  
SOMANETICS CORP.
TROY,  MI ,  US.
SOMAR IMPORT & EXPORT
EAGLE PASS,  TX,  US.
Initial Importer;  
SOMAR IMPORT & EXPORT
EAGLE PASS,  TX ,  US.
SOMAS INTERNATIONAL B.V.
SINT ANTHONIS,  NL.
Foreign Exporter;  
SOMAS INTERNATIONAL B.V.
SINT ANTHONIS,  NL.
SOMATICS, LLC
LAKE BLUFF,  IL,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SOMATICS, LLC
LAKE BLUFF,  IL ,  US.
SOMECS IMPORT EXPORT LTD.
BROOKLYN,  NY,  US.
Initial Importer;  
SOMECS IMPORT EXPORT LTD.
BROOKLYN,  NY ,  US.
SOMEDIC SALES AB
HORBY,  SW.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
SOMEDIC SALES AB
HORBY,  SW.
SOMEDICS
RIS ORANGIS,  FR.
Manufacturer;  
SOMEDICS
RIS ORANGIS,  FR.
SOMER DENTAL LABORATORIES
ZIONSVILLE,  IN,  US.
Initial Importer;  
SOMER DENTAL LABORATORIES
ZIONSVILLE,  IN ,  US.
SOMERVELL LABORATORIES
GLEN ROSE,  TX,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
STRAIN & STRAIN L.L. CO.
GLEN ROSE,  TX ,  US.
SOMETEC, SA
PARIS,  FR.
Unregistered Foreign Lister;  
SOMETEC, SA
PARIS,  FR.
SOMETECH CORPORATION
NORCROSS,  GA,  US.
Initial Importer;  
SOMETECH, INC.
SEOUL,  KS.
SOMETECH INCORPORATED
SEOUL,  KS.
Foreign Exporter;   Manufacturer;   Specification Developer;  
SOMETECH, INC.
SEOUL,  KS.
SOMNO TECH, L.L.C.
MONROEVILLE,  PA,  US.
Initial Importer;  
SOMNO TECH, L.L.C.
MONROEVILLE,  PA ,  US.
SOMNOMED INC.
DENTON,  TX,  US.
Initial Importer;  
SOMNOMED, LTD.
CROWS NEST,  AS.
SOMNOMED, LTD.
CROWS NEST,  AS.
Foreign Exporter;   Manufacturer;  
SOMNOMED, LTD.
CROWS NEST,  AS.
SOMO LENS, LLC
SANTA FE SPRINGS,  CA,  US.
Initial Importer;  
SOMO LENS, LLC
SANTA FE SPRINGS,  CA ,  US.
SOMO OPTICAL CO., LTD.
KANGWON-DO,  KS.
Manufacturer;  
SOMO OPTICAL CO., LTD.
KANGNAM-GU, SEOUL,  KS.
SONA ENT.
PARAMOUNT,  CA,  US.
Initial Importer;  
SONA ENT.
PARAMOUNT,  CA ,  US.
SONAGE/SELECTIVE ESTHETICS
CHATSWORTH,  CA,  US.
Initial Importer;  
SONAGE/SELECTIVE ESTHETICS
CHATSWORTH,  CA ,  US.
SONAMED CORP.
WALTHAM,  MA,  US.
Manufacturer;  
SONAMED CORP.
WALTHAM,  MA ,  US.
SONG YI PLASTICS INDUSTRIAL CO., LTD.
GUANGXHOU, GUANGDONG,  CH.
Contract Manufacturer;  
ELITE ENGINEERING INDUSTRIAL CORP.
TAIPEI HSIEN,  TW.
SONG YOUNG INTL.
TAIPEI,  TW.
Unregistered Foreign Lister;  
SONG YOUNG INTL. CO.
TAIPEI,  TW.
SONG YOUNG INTL. CO.
TAIPEI,  TW.
Manufacturer;  
SONG YOUNG INTL. CO.
TAIPEI,  TW.

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Last Modified: 29 April 2006
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