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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
SPECTRUM MEDICAL X-RAY CO.
SANTA MONICA,  CA,  US.
Initial Importer;  
SPECTRUM MEDICAL X-RAY CO.
SANTA MONICA,  CA ,  US.
SPECTRUM OPTICAL
LOS ANGELES,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
SPECTRUM OPTICAL
LOS ANGELES,  CA ,  US.
SPECTRUM PRODUCTS USA
PHOENIX,  AZ,  US.
Contract Manufacturer;  
SPECTRUM PRODUCTS USA
PHOENIX,  AZ ,  US.
SPECTRUM PRODUCTS, LLC
MISSOULA,  MT,  US.
Manufacturer;   Specification Developer;  
THE MENDOTA GROUP, INC.
MADISON,  WI ,  US.
SPECTRUM SCIENTIFIC, INC.
NORTHVILLE,  MI,  US.
Specification Developer;   Repackager/Relabeller;  
SPECTRUM SCIENTIFIC, INC.
NORTHVILLE,  MI ,  US.
SPECTRUM SOURCE CORP.
NEW YORK,  NY,  US.
Initial Importer;  
SPECTRUM SOURCE CORP.
NEW YORK,  NY ,  US.
SPECTRUM SURGICAL SUPPLIES
SIALKOT,  PK.
Manufacturer;  
SPECTRUM SURGICAL SUPPLIES
SIALKOT,  PK.
SPECTRUM SURGICAL SUPPLY CORP.
STOW,  OH,  US.
Initial Importer;  
SPECTRUM SURGICAL SUPPLY CORP.
STOW,  OH ,  US.
SPECTRUM SYSTEMS, LLC
YORK,  PA,  US.
Specification Developer;  
SPECTRUM SYSTEMS, LLC
YORK,  PA ,  US.
SPECTRUM TECHNOLOGIES
HEALDSBURG,  CA,  US.
Initial Importer;  
SPECTRUM TECHNOLOGIES
HEALDSBURG,  CA ,  US.
SPECTRUM TECHNOLOGY
CINCINNATI,  OH,  US.
Manufacturer;  
SPECTRUM TECHNOLOGY
CINCINNATI,  OH ,  US.
SPECTRUM THERAPY PRODUCTS, INC.
JASPER,  MI,  US.

SPECTRUM THERAPY PRODUCTS, INC.
JASPER,  MI ,  US.
SPECTRUMMED, INC.
LIVINGSTON,  NJ,  US.
Initial Importer;  
SPECTRUMMED, INC.
LIVINGSTON,  NJ ,  US.
SPECTRX, INC.
NORCROSS,  GA,  US.
Manufacturer;   Specification Developer;  
SPECTRX, INC.
NORCROSS,  GA ,  US.
SPECWELL CORP.
TOKYO,  JA.
Manufacturer;  
SPECWELL CORP.
TOKYO,  JA.
SPEECHEASY INTERNATIONAL, LLC
GREENVILLE,  NC,  US.
Remanufacturer;  
JANUS DEVELOPMENT GROUP, INC.
GREENVILLE,  NC ,  US.
SPEED FAIR CO., LTD.
CAUSEWAY BAY,  HK.
Unregistered Foreign Lister;  
SPEED FAIR CO., LTD.
CAUSEWAY BAY,  HK.
SPEEDENT CORP.
TAIPEI,  TW.
Manufacturer;  
SPEEDENT CORP.
TAIPEI,  TW.
SPEEDENT DENTAL SUPPLIES
MONTCLAIR,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PRECISION CERAMICS DENTAL LABORATORY
MONTCLAIR,  CA ,  US.
SPEEDSTAR INDUSTRIES CO., LTD.
KAOHSIUNG, TAIWAN,  TW.
Manufacturer;  
SPEEDSTAR INDUSTRIES CO., LTD.
KAOHSIUNG, TAIWAN,  TW.
SPEEDTECH SDN BHD
SELANGOR DARUL EHSAN,  MY.
Manufacturer;  
SPEEDTECH SDN BHD
SELANGOR DARUL EHSAN,  MY.
SPEEDWAY SURGICAL CO.
CHANDNI CHOWK, DELHI,  IN.
Unregistered Foreign Lister;  
SPEEDWAY SURGICAL CO.
CHANDNI CHOWK, DELHI,  IN.
SPEEDY-TECH ELECTRONICS (HK) LTD.
NANXUN, HUZHOU, ZHEJIANG,  CH.
Unregistered Foreign Lister;  
SPEEDY-TECH ELECTRONICS (HK) LTD.
NANXUN, HUZHOU, ZHEJIANG,  CH.
SPEIKO-DR. SPEIER GMBH
MUNSTER,  GM.
Manufacturer;  
SPEIKO-DR. SPEIER GMBH
MUNSTER,  GM.
SPEKKLES
WEST DRAYTON MIDDX,  UK.
Specification Developer;  
SPEKKLES
WEST DRAYTON MIDDX,  UK.
SPELL INT'L USA, INC.
WILLINGBORO,  NJ,  US.
Initial Importer;  
SURGICON, LTD.
SIALKOT, PUNJAB,  PK.
SPELLMAN HIGH VOLTAGE ELECTRONICS CORP.
HAUPPAUGE,  NY,  US.
Manufacturer;  
SPELLMAN HIGH VOLTAGE ELECTRONICS CORP.
HAUPPAUGE,  NY ,  US.
SPENCER GIFTS, LLC
EGG HARBOR TOWNSHIP,  NJ,  US.
Initial Importer;  
SPENCER GIFTS, LLC
EGG HARBOR TOWNSHIP,  NJ ,  US.
SPENCER TECHNOLOGIES
SEATTLE,  WA,  US.
Manufacturer;  
SPENCER TECHNOLOGIES
SEATTLE,  WA ,  US.
SPENCO MEDICAL CORP.
WACO,  TX,  US.
Initial Importer;   Manufacturer;  
SBS ENTERPRISES
WACO,  TX ,  US.
SPES MEDICA S.R.L.
BATTIPAGLIA,  IT.
Manufacturer;  
SPES MEDICA S.R.L.
BATTIPAGLIA,  IT.
SPEXTRA ENTERPRISE COMPANY LTD.
TAINAN,  TW.
Manufacturer;  
SPEXTRA ENTERPRISE COMPANY LTD.
TAINAN,  TW.
SPF OPTICAL
AIEA,  HI,  US.
Initial Importer;  
SPF OPTICAL
AIEA,  HI ,  US.
SPG DE MEXICO S.A. DE C.V.
MEXICALI, BAJA CALIFORNIA,  MX.
Foreign Exporter;   Manufacturer;  
SANFORD, L.P.
OAK BROOK,  IL ,  US.
SPHINX TOOLS LTD.
DERENDINGEN,  SZ.
Manufacturer;  
SPHINX TOOLS LTD.
DERENDINGEN,  SZ.
SPI DENTAL MFG., INC.
BAYSIDE,  NY,  US.
Initial Importer;  
SPI DENTAL MFG., INC.
BAYSIDE,  NY ,  US.
SPICES USA, INC.
MIAMI,  FL,  US.
Initial Importer;  
SPICES USA, INC.
MIAMI,  FL ,  US.
SPICO, INC.
ORLANDO,  FL,  US.
Initial Importer;  
SPICO, INC.
ORLANDO,  FL ,  US.
SPIEGEL CATALOG, INC.
DOWNERS GROVE,  IL,  US.
Initial Importer;  
SPIEGEL, INC.
DOWNERS GROVE,  IL ,  US.
SPIERINGS ORTHOPAEDICS B.V.
NIJMEGEN,  NL.
Specification Developer;  
SPIERINGS ORTHOPAEDICS B.V.
NIJMEGEN,  NL.

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Last Modified: 29 April 2006
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