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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
REEDCO, INC.
HUMACAO,  PR,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
SMITHKLINE BEECHAM CONSUMER HEALTHCARE, L.P.
PITTSBURG,  PA ,  US.
REEL RESEARCH AND DEVELOPMENT, INC.
BEN LOMOND,  CA,  US.
Manufacturer;  
REEL RESEARCH AND DEVELOPMENT, INC.
BEN LOMOND,  CA ,  US.
REEVES EMERGENCY MANAGEMENT SYSTEMS, LLC.
FREDERICK,  MD,  US.
Manufacturer;  
REEVES EMERGENCY MANAGEMENT SYSTEMS, LLC.
FREDERICK,  MD ,  US.
REEVES-SAIN MEDICAL
MURFREESBORO,  TN,  US.
Initial Importer;  
SHANE REEVES
MURFREESBORO,  TN ,  US.
REFERENCE DIAGNOSTICS, INC.
BEDFORD,  MA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
REFERENCE DIAGNOSTICS, INC.
BEDFORD,  MA ,  US.
REFINEMENT OPTICAL MFG. CO., LTD.
KWUN TONG, KOWLOON,  HK.
Manufacturer;  
REFINEMENT OPTICAL MFG. CO., LTD.
KWUN TONG, KOWLOON,  HK.
REFLECT EYES INC.
FLANDERS,  NJ,  US.
Initial Importer;  
REFLECT EYES INC.
LYNNBROOK,  NY ,  US.
REFLECTO CO., LTD.
TAIPEI,  TW.
Manufacturer;  
REFLECTO CO., LTD.
TAIPEI,  TW.
REFLEX INDUSTRIES, INC.
SANTEE,  CA,  US.
Manufacturer;  
REFLEX INDUSTRIES, INC.
SAN DIEGO,  CA ,  US.
REFLEX SRL
SOSPIROLO,  IT.
Manufacturer;  
REFLEX SRL
SOSPIROLO,  IT.
REFLEX TECHNOLOGIES, INC.
NORTH MIAMI,  FL,  US.
Manufacturer;  
REFLEX TECHNOLOGIES, INC.
NORTH MIAMI,  FL ,  US.
REFOCUS GROUP, INC.
DALLAS,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
REFOCUS GROUP, INC.
DALLAS,  TX ,  US.
REFRACTEC, INC.
IRVINE,  CA,  US.
Manufacturer;   Specification Developer;  
REFRACTEC, INC.
IRVINE,  CA ,  US.
REFRACTEC, INC.
IRVINE,  CA,  US.
Manufacturer;   Specification Developer;  
REFRACTEC, INC.
IRVINE,  CA ,  US.
REGAL MEDI-SPA CO., INC.
MARKHAM, ON,  CA.
Manufacturer;  
DEVJO HOLDINGS LTD.
MARKHAM, ON,  CA.
REGAL OPTICAL PTY LTD.
WACOL, QUEENSLAND,  AS.
Unregistered Foreign Lister;  
REGAL OPTICAL PTY LTD.
WACOL, QUEENSLAND,  AS.
REGAL PROSTHESIS LTD.
KOWLOON,  HK.
Manufacturer;  
REGAL PROSTHESIS LTD.
KOWLOON,  HK.
REGAL SALES ASSOCIATES, INC.
COVENTRY,  RI,  US.
Initial Importer;  
REGAL SALES ASSOCIATES, INC.
COVENTRY,  RI ,  US.
REGALTEX INTL., INC.
AVENEL,  NJ,  US.
Initial Importer;  
REGALTEX INTL., INC.
AVENEL,  NJ ,  US.
REGANESTH MEDIZINTECHNIK GMBH
VS-VILLINGEN, BADEN-WURTEMBERG,  GM.
Manufacturer;  
REGANESTH MEDIZINTECHNIK GMBH
VS-VILLINGEN, BADEN-WURTEMBERG,  GM.
REGE VENTURES, INC.
KEY BISCAYNE,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
REGE VENTURES, INC.
KEY BISCAYNE,  FL ,  US.
REGEN BIOLOGICS, INC.
REDWOOD CITY,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
REGEN BIOLOGICS, INC.
REDWOOD CITY,  CA ,  US.
REGENCY MERCHANDISE, INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
REGENCY MERCHANDISE, INC.
LOS ANGELES,  CA ,  US.
REGENERATION TECHNOLOGIES, INC.
ALACHUA,  FL,  US.
Manufacturer;  
REGENERATION TECHNOLOGIES, INC.
ALACHUA,  FL ,  US.
REGENESIS BIOMEDICAL, INC.
SCOTTSDALE,  AZ,  US.
Specification Developer;  
REGENESIS BIOMEDICAL, INC.
SCOTTSDALE,  AZ ,  US.
REGENT BABY PRODUCTS CORP.
JAMAICA,  NY,  US.
Initial Importer;  
REGENT BABY PRODUCTS CORP.
JAMAICA,  NY ,  US.
REGENT GLOBAL COMPANY LIMITED
HONG KONG,  HK.
Manufacturer;  
REGENT GLOBAL COMPANY LIMITED
HONG KONG,  HK.
REGENT GROUP CO., LTD.
HSIN CHU,  TW.
Manufacturer;  
TZE-YU CHOU/REGENT GROUP CO., LTD.
TAIPEI,  TW.
REGENT HOSPITAL PRODUCTS, SDN BHD
KULIM, KEDAH DARULAMAN,  MY.
Manufacturer;  
REGENT MEDICAL OVERSEAS LIMITED
IRLAM,  UK.
REGENT LABS, INC.
DEERFIELD BEACH,  FL,  US.
Manufacturer;  
REGENT LABS, INC.
DEERFIELD BEACH,  FL ,  US.
REGENT MEDICAL AMERICAS, LLC
NORCROSS,  GA,  US.
Specification Developer;  
REGENT MEDICAL OVERSEAS LIMITED
IRLAM,  UK.
REGENT MEDICAL AMERICAS, LLC DISTRIBUTION CENTER
ANDERSON,  SC,  US.
Initial Importer;  
REGENT MEDICAL OVERSEAS LIMITED
IRLAM,  UK.
REGENT MEDICAL LTD
IRLAM,  UK.
Specification Developer;  
REGENT MEDICAL OVERSEAS LIMITED
IRLAM,  UK.
REGENT SPORTS CORP.
HAUPPAUGE,  NY,  US.
Initial Importer;  
REGENT SPORTS CORP.
HAUPPAUGE,  NY ,  US.
REGINAL MEDICAL SOLUTIONS, INC.
SANTA CLARA,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
REGINAL MEDICAL SOLUTIONS, INC.
SANTA CLARA,  CA ,  US.
REGINE SWITZERLAND
MORBIO, INFERIORE,  SZ.
Manufacturer;  
REGINE SWITZERLAND
MORBIO, INFERIORE,  SZ.
REGITAR U.S.A., INC.
MONTGOMERY,  AL,  US.
Initial Importer;  
STONE WALL INDUSTRIAL CO.
TAIPEI,  TW.
REGO X-RAY GMBH
AUGSBURG,  GM.
Manufacturer;  
REGO X-RAY GMBH
AUGSBURG,  GM.
REHAB DESIGNS OF COLORADO
DENVER,  CO,  US.
Initial Importer;  
REHAB DESIGNS OF AMERICA
RIVERSIDE,  MO ,  US.
REHAB FABRICATORS, INC.
SYRACUSE,  NY,  US.
Manufacturer;  
REHAB FABRICATORS, INC.
SYRACUSE,  NY ,  US.

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Last Modified: 29 April 2006
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