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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
SABU, LLC
POMPANO BEACH,  FL,  US.
Specification Developer;  
SABU, LLC
MARGATE,  FL ,  US.
SAC SANTE, INC.
VILLE ST-LAURENT, QC,  CA.
Unregistered Foreign Lister;  
SAC SANTE, INC.
VILLE ST-LAURENT, QC,  CA.
SACKS FARMS BIOLOGICAL PRODUCTS
EVANS CITY,  PA,  US.
Initial Importer;  
SACKS BIOLOGICALS
EVANS CITY,  PA ,  US.
SACKS MEDICAL CORPORATION
EVANS CITY,  PA,  US.
Repackager/Relabeller;  
SACKS MEDICAL CORPORATION
EVANS CITY,  PA ,  US.
SACO INTL.
SIALKOT,  PK.
Manufacturer;  
SACO INTL.
SIALKOT,  PK.
SACRED INTERNATIONAL
SIALKOT, PUNJAB,  PK.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
SACRED INTERNATIONAL
SIALKOT, PUNJAB,  PK.
SAE BIANG OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
SAE BIANG OPTICAL CO.
DAEGU,  KS.
SAE HAN MEDICAL CORP.
GOYANG CITY, GYUNGGI-DO,  KS.
Manufacturer;  
SAE HAN MEDICAL CORP.
GOYANG CITY, GYUNGGI-DO,  KS.
SAE IK MEDICAL CO., LTD.
BUCHEON-CITY, KYUNGGI-DO,  KS.
Manufacturer;  
SAE IK MEDICAL CO., LTD.
BUCHEON-CITY, KYUNGGI-DO,  KS.
SAE JONG OPTICAL CO.
DAEGU,  KS.
Unregistered Foreign Lister;  
SAE JONG OPTICAL CO.
DAEGU,  KS.
SAE KWANG CO.
TAEGU,  KS.
Manufacturer;  
SAE KWANG CO.
TAEGU,  KS.
SAE MATERIALS, INC.
SANTA CLARA,  CA,  US.
Contract Manufacturer;  
SAE MATERIALS, INC.
SANTA CLARA,  CA ,  US.
SAE MYUNG INDUSTRIAL CO.
TAEGU,  KS.
Unregistered Foreign Lister;  
SAE MYUNG INDUSTRIAL CO.
TAEGU,  KS.
SAE MYUNG OPTICAL CO.
BUK-GU, TAEGU,  KS.
Manufacturer;  
SAE MYUNG OPTICAL CO.
BUK-GU, TAEGU,  KS.
SAE SHIN INDUSTRIAL CO.
TAEGU,  KS.
Unregistered Foreign Lister;  
SAE SHIN INDUSTRIAL CO.
TAEGU,  KS.
SAE SHIN PRECISION INDUSTRIAL CO.
DAEGU,  KS.
Unregistered Foreign Lister;  
SAE SHIN PRECISION INDUSTRIAL CO.
DAEGU,  KS.
SAE YANG COMPANY
TAEGU,,  KS.
Manufacturer;  
SAE YANG COMPANY
TAEGU,,  KS.
SAEED CLASSICAL WORKS
PUNJAB, SIALKOT-4,  PK.
Manufacturer;  
SAEED CLASSICAL WORKS
PUNJAB, SIALKOT-4,  PK.
SAEGI TRADING CO.
DAEGU,  KS.
Unregistered Foreign Lister;  
SAEGI TRADING CO.
DAEGU,  KS.
SAEHAN CORPORATION
MASAN, KYUNGSANGNAM-DO,  KS.
Manufacturer;  
SAEHAN CORPORATION
MASAN, KYUNGSANGNAM-DO,  KS.
SAEHAN MEDITECH
SEOUL,  KS.
Manufacturer;  
SAEHAN MEDITECH
SEOUL,  KS.
SAEID E. JALAYER
SHOREHAM,  NY,  US.
Initial Importer;  
SAEID E. JALAYER
SHOREHAM,  NY ,  US.
SAEIK MEDICAL CO., LTD.
BUCHEON-CITY, GYEONGGI-DO,  KS.
Manufacturer;  
SAEIK MEDICAL CO., LTD.
BUCHEON-CITY, GYEONGGI-DO,  KS.
SAEJIN CORP.
EYUNPYUNG-GU, SEOUL,  KS.
Unregistered Foreign Lister;  
SAEJIN CORP.
EYUNPYUNG-GU, SEOUL,  KS.
SAFA MEDICAL LTD.
WARRINGTON,  UK.
Foreign Exporter;   Manufacturer;   Specification Developer;  
SAFA MEDICAL LTD.
WARRINGTON,  UK.
SAFARI DENTAL, INC.
BOISBRIAND, QUEBEC,  CA.
Manufacturer;  
SAFARI DENTAL, INC.
BOISBRIAND, QUEBEC,  CA.
SAFARI IMPEX
SIALKOT, PUNJAB,  PK.
Manufacturer;  
SAFARI IMPEX
SIALKOT, PUNJAB,  PK.
SAFCO DENTAL SUPPLY
NORTHBROOK,  IL,  US.
Initial Importer;  
SAFCO DENTAL SUPPLY
NORTHBROOK,  IL ,  US.
SAFCO PRODUCTS CO.
NEW HOPE,  MN,  US.
Initial Importer;   Specification Developer;  
LIBERTY DIVERSIFIED INDUSTRIES
NEW HOPE,  MN ,  US.
SAFE CLEANERS, LLC.
WYOMING,  MI,  US.
Repackager/Relabeller;  
SAFE CLEANERS, LLC.
WYOMING,  MI ,  US.
SAFE GLOVE CO., LTD.
AMPHUR MUANG, SURATTHANI,  TH.
Manufacturer;  
SAFE GLOVE CO., LTD.
AMPHUR MUANG, SURATTHANI,  TH.
SAFE GUARD NEEDLE
MUNDELEIN,  IL,  US.
Specification Developer;  
SAFE GUARD NEEDLE
MUNDELEIN,  IL ,  US.
SAFE MEDICAL SYSTEMS, LLC.
WOODSTOCK,  GA,  US.
Initial Importer;  
POST MEDICAL, INC.
WOODSTOCK,  GA ,  US.
SAFE SHIELD CO. LTD
PHUNPHIN, SURATTHANI,  TH.
Manufacturer;  
SAFE SHIELD CO. LTD
PHUNPHIN, SURATTHANI,  TH.
SAFE SOLUTIONS, INC.
MARNE,  MI,  US.
Manufacturer;  
SAFE SOLUTIONS, INC.
MARNE,  MI ,  US.
SAFE+CARE MEDICAL SUPPLIES INC.
STATEN ISLAND,  NY,  US.
Initial Importer;  
SAFE+CARE MEDICAL SUPPLIES INC.
STATEN ISLAND,  NY ,  US.
SAFECARE CORPORATION
BATON ROUGE,  LA,  US.
Manufacturer;  
SAFECARE CORPORATION
BATON ROUGE,  LA ,  US.
SAFECO AMERICA
WILLOUGHBY,  OH,  US.
Initial Importer;  
SAFETY SUPPLY CANADA, LTD.
RICHMOND HILL, ONTARIO,  CA.
SAFECROSS FIRST AID LTD.
TORONTO, ONTARIO,  CA.
Repackager/Relabeller;  
SAFECROSS FIRST AID LTD.
TORONTO, ONTARIO,  CA.
SAFEGARD MEDICAL (HUNGARY), LTD.
FARKASLYUK,  HU.
Manufacturer;  
SAFEGARD MEDICAL, LMT.
HAMILTON,  BD.

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Last Modified: 29 April 2006
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