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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
SMALL BEGINNINGS, INC.
HESPERIA,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SMALL BEGINNINGS, INC.
HESPERIA,  CA ,  US.
SMALL BONE INNOVATIONS INTERNATIONAL, SA
PERONNAS,  FR.
Manufacturer;  
SMALL BONE INNOVATIONS, INC.
NEW YORK,  NY ,  US.
SMALL BONE INNOVATIONS, INC.
MORRISVILLE,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
SMALL BONE INNOVATIONS, INC.
NEW YORK,  NY ,  US.
SMALL BONE INNOVATIONS, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
SMALL BONE INNOVATIONS, INC.
NEW YORK,  NY ,  US.
SMALL FLAGS
OREGON CITY,  OR,  US.
Initial Importer;  
GIFFORD & SONS, LLC
OREGON CITY,  OR ,  US.
SMALL PARTS, INC.
MIAMI LAKES,  FL,  US.
Repackager/Relabeller;  
SMALL PARTS, INC.
MIAMI LAKES,  FL ,  US.
SMART GEAR ACCESSORIES L.L.C.
OCEAN,  NJ,  US.
Initial Importer;  
SMART GEAR ACCESSORIES L.L.C.
OCEAN,  NJ ,  US.
SMART GIFT INC.
NORTH MIAMI BEACH,  FL,  US.
Initial Importer;  
SMART GIFT INC.
NORTH MIAMI BEACH,  FL ,  US.
SMART GLOVE CORP. SDN BHD
KLANG SELANGOR,  MY.
Manufacturer;  
SMART GLOVE CORP. SDN BHD
KLANG SELANGOR,  MY.
SMART INNOVATIONS INC.
CANOGA PARK,  CA,  US.
Initial Importer;  
SMART INNOVATIONS INC.
CANOGA PARK,  CA ,  US.
SMART MATERIALS
NORTON,  MA,  US.
Contract Manufacturer;  
SMART MATERIALS
NORTON,  MA ,  US.
SMART MEDICAL TECHNOLOGY, INC
DARIEN,  IL,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
SMART MEDICAL TECHNOLOGY, INC
DARIEN,  IL ,  US.
SMART OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
SMART OPTICAL CO.
DAEGU,  KS.
SMART OPTICAL, INCORPORATION
CHICAGO,  IL,  US.
Initial Importer;  
SHUI MAN WONG
CHICAGO,  IL ,  US.
SMART PRACTICE
PHOENIX,  AZ,  US.
Initial Importer;   Repackager/Relabeller;  
SMART PRACTICE
PHOENIX,  AZ ,  US.
SMART SUCCESS (HONG KONG) LIMITED
SHENZHEN,  CH.
Foreign Exporter;  
SMART SUCCESS (HONG KONG) LIMITED
SHENZHEN,  CH.
SMART THERAPEUTICS, INC.
SAN LEANDRO,  CA,  US.
Manufacturer;  
SMART THERAPEUTICS, INC.
SAN LEANDRO,  CA ,  US.
SMART VICTORY OPTICAL MFY. CO. LTD.
TSUEN WAN, NEW TERRITORIES,  HK.
Manufacturer;  
SMART VICTORY OPTICAL MFY. CO. LTD.
TSUEN WAN, NEW TERRITORIES,  HK.
SMARTECH PRECISION CERAMIC TECHNOLOGY (SHENZHEN) C
DISTRICT, SHENZHEN CITY,  CH.
Manufacturer;  
SMARTECH PRECISION CERAMIC TECHNOLOGY (SHENZHEN) C
DISTRICT, SHENZHEN CITY,  CH.
SMARTER FUND LIMITED
KWUN TONG, KOWLOON,  HK.
Foreign Exporter;  
SMARTER FUND LIMITED
KWUN TONG, KOWLOON,  HK.
SMARTLIGHT, INC.
FAIRLAWN,  NJ,  US.
Initial Importer;  
SMARTLIGHT, LTD.
YOKNEAM ELITE,  IS.
SMARTSCIENCE LABORATORIES, INC.
ODESSA,  FL,  US.
Repackager/Relabeller;  
SMARTSCIENCE LABORATORIES, INC.
ODESSA,  FL ,  US.
SMB CORPORATION OF INDIA
JOGESHWARI(E), MAHARASHTRA,  IN.
Manufacturer;  
SMB CORPORATION OF INDIA
JOGESHWARI(E), MAHARASHTRA,  IN.
SMB SA
S. ANTONIO,  SZ.
Manufacturer;  
SMB SA
S. ANTONIO,  SZ.
SMC MEDICAL MANUFACTURING DIVISION
SOMERSET,  WI,  US.
Contract Manufacturer;   Manufacturer;  
SCIENTIFIC MOLDING CORPORATION LTD
SOMERSET,  WI ,  US.
SMC PNEUMATICS (UK) LTD.
MILTON KEYNES, BUCKINGHAMSHIRE,  UK.
Contract Manufacturer;  
SMC PNEUMATICS (UK) LTD.
MILTON KEYNES, BUCKINGHAMSHIRE,  UK.
SMI DIV. OF SOHN MFG., INC.
ELKHART LAKE,  WI,  US.
Contract Manufacturer;  
SMI DIV. OF SOHN MFG., INC.
ELKHART LAKE,  WI ,  US.
SMI HOME PRODUCTS, INC.
GLEN GARDNER,  NJ,  US.
Initial Importer;  
SMI HOME PRODUCTS, INC.
GLEN GARDNER,  NJ ,  US.
SMILE BRITE DISTRIBUTING LLC
PITTSFORD,  NY,  US.
Manufacturer;  
SMILE BRITE DISTRIBUTING LLC
PITTSFORD,  NY ,  US.
SMILE DENTAL LAB
TOWN, SHENZHEN, GUANGDONG,  CH.
Contract Manufacturer;  
SMILE DENTAL LAB
TOWN, SHENZHEN, GUANGDONG,  CH.
SMILE INDUSTRIES LTD.
FANLING,N.T.,  HK.
Unregistered Foreign Lister;  
SMILE INDUSTRIES LTD.
FANLING,N.T.,  HK.
SMILE INTERNATIONAL TRADING
CHESTERFIELD,  VA,  US.
Initial Importer;  
SMILE INTERNATIONAL TRADING
CHESTERFIELD,  VA ,  US.
SMILE MAKERS, INC.
SPARTANBURG,  SC,  US.
Initial Importer;  
SMILE MAKERS, INC.
SPARTANBURG,  SC ,  US.
SMILE OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
SMILE OPTICAL CO.
DAEGU,  KS.
SMILEN EYEWEAR
CEDARHURST,  NY,  US.
Initial Importer;  
SMILE EYE INC.
CEDARHURST,  NY ,  US.
SMIT ROENTGEN
BEST,  NL.
Foreign Exporter;  
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
BOTHELL,  WA ,  US.
SMITH & NEPHEW ORTHOPAEDICS, GMBH
TUTTLINGEN,  GM.
Manufacturer;  
SMITH & NEPHEW, INC.
MEMPHIS,  TN ,  US.
SMITH & NEPHEW ORTHOPEADICS LTD.
BROMSGROVE,  UK.
Specification Developer;  
SMITH & NEPHEW, INC.
MEMPHIS,  TN ,  US.
SMITH & NEPHEW, INC.
ANDOVER,  MA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SMITH & NEPHEW, INC.
ANDOVER,  MA ,  US.
SMITH & NEPHEW, INC.
ANDOVER,  MA,  US.
Manufacturer;   Specification Developer;  
SMITH & NEPHEW, INC.
ANDOVER,  MA ,  US.

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Last Modified: 29 April 2006
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