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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
ROXANA TOYS, INC.
RIO PIEDRAS,  PR,  US.
Initial Importer;  
ROXANA TOYS, INC.
RIO PIEDRAS,  PR ,  US.
ROYAL AMERICAN INDUSTRIES, INC.
BOCA RATON,  FL,  US.
Initial Importer;  
ROYAL AMERICAN INDUSTRIES, INC.
BOCA RATON,  FL ,  US.
ROYAL APPLIANCE MFG. CO.
GLENWILLOW,  OH,  US.
Initial Importer;  
ROYAL APPLIANCE MFG. CO.
GLENWILLOW,  OH ,  US.
ROYAL BROWN BEVERAGE SURGICAL SUPPLIES
SIALKOT,  PK.
Unregistered Foreign Lister;  
ROYAL BROWN BEVERAGE SURGICAL SUPPLIES
SIALKOT,  PK.
ROYAL CONVERTING, INC.
POWELL,  TN,  US.
Contract Manufacturer;  
DEROYAL
POWELL,  TN ,  US.
ROYAL CORONA
CENTER CONWAY,  NH,  US.
Initial Importer;  
ROYAL CORONA
CENTER CONWAY,  NH ,  US.
ROYAL DENTAL LABORATORY
NAN SHAN,SHENZHEN,GUANG DONG,  CH.
Manufacturer;  
ROYAL DENTAL LABORATORY
NAN SHAN,SHENZHEN,GUANG DONG,  CH.
ROYAL DENTAL MFG., INC.
EVERETT,  WA,  US.
Initial Importer;   Manufacturer;  
ROYAL DENTAL MFG., INC.
EVERETT,  WA ,  US.
ROYAL FASHION OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
ROYAL FASHION OPTICAL CO.
DAEGU,  KS.
ROYAL FLASH ENTERPRISE CO. LTD.
TAINAN CITY,  TW.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ROYAL FLASH ENTERPRISE CO. LTD.
TAINAN CITY,  TW.
ROYAL HERITAGE HOME BASICS LLC
GREAT NECK,  NY,  US.
Manufacturer;  
ROYAL HERITAGE HOME BASICS LLC
GREAT NECK,  NY ,  US.
ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD.
SAMUTSAKORN,  TH.
Manufacturer;  
ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD.
SAMUTSAKORN,  TH.
ROYAL INDUSTRIES THAILAND CO., LTD.
SIAM-SQ BANKOK,  TH.
Manufacturer;  
ROYAL INDUSTRIES THAILAND CO., LTD.
SIAM-SQ BANKOK,  TH.
ROYAL ITEMS, INC.
NEW YORK,  NY,  US.
Initial Importer;  
ROYAL ITEMS, INC.
NEW YORK,  NY ,  US.
ROYAL KING INFANT PRODUCTS CO. LTD.
KRATHUMBAEN, SAMUTSAKOR,  TH.
Contract Manufacturer;   Manufacturer;  
ROYAL KING INFANT PRODUCTS CO. LTD.
KRATHUMBAEN, SAMUTSAKON,  TH.
ROYAL KING INFANT PRODUCTS CO. LTD.
WANG BURAPHA, BANGKOK,  TH.
Unregistered Foreign Lister;  
ROYAL KING INFANT PRODUCTS CO. LTD.
WANG BURAPHA, BANGKOK,  TH.
ROYAL LATEX GLOVES INTERNATIONAL, INC.
AVENTURA,  FL,  US.
Initial Importer;  
ROYAL LATEX GLOVES INTERNATIONAL, INC.
AVENTURA,  FL ,  US.
ROYAL MEDICA SRL
S. PIETRO IN GU' (PD),  IT.
Unregistered Foreign Lister;  
ROYAL MEDICA SRL
S. PIETRO IN GU' (PD),  IT.
ROYAL PACIFIC INTL. TRADE, INC.
NEW YORK,  NY,  US.
Initial Importer;  
ROYAL PACIFIC INTL. TRADE, INC.
NEW YORK,  NY ,  US.
ROYAL PAPER PRODUCTS, INC.
COATESVILLE,  PA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ROYAL PAPER PRODUCTS, INC.
COATESVILLE,  PA ,  US.
ROYAL PLASTIC SARL
OYONNAX,  FR.
Manufacturer;  
ROYAL PLASTIC SARL
OYONNAX,  FR.
ROYAL PLASTICS, INC.
BROOKINGS,  SD,  US.
Contract Manufacturer;  
ROYAL PLASTICS, INC.
BROOKINGS,  SD ,  US.
ROYAL PRECISION PLASTICS
POWELL,  TN,  US.
Contract Manufacturer;   Manufacturer;  
DEROYAL INDUSTRIES, INC.
POWELL,  TN ,  US.
ROYAL SHINE ENTERPRISES, LTD.
TAIPEI,  TW.
Manufacturer;  
ROYAL SHINE ENTERPRISES, LTD.
TAIPEI,  TW.
ROYAL STERILIZATION SYSTEMS
NEW TAZEWELL,  TN,  US.
Contract Sterilizer;  
DEROYAL INDUSTRIES, INC.
POWELL,  TN ,  US.
ROYAL SURGICAL INSTRUMENTS, INC.
LEWISTOWN,  IL,  US.
Manufacturer;  
ROYAL SURGICAL INSTRUMENTS, INC.
LEWISTOWN,  IL ,  US.
ROYAL TIMES, INC.
NEW YORK,  NY,  US.
Initial Importer;  
ROYAL TIMES, INC.
NEW YORK,  NY ,  US.
ROYAL TOOTH BRUSHES, INC.
NEW ROCHELLE,  NY,  US.
Initial Importer;  
ROYAL TOOTH BRUSHES, INC.
NEW ROCHELLE,  NY ,  US.
ROYAL TOOTHBRUSHES (P) LTD.
NASHIK,  IN.
Contract Manufacturer;   Manufacturer;  
ROYAL BRUSHES PVT. LTD.
MUMBAI,  IN.
ROYAL VENTURE
KOWLOON,  HK.
Foreign Exporter;  
ROYAL VENTURE
KOWLOON,  HK.
ROYAL VISION INTERNATIONAL, INC.
WALNUT,  CA,  US.
Initial Importer;  
ROYAL VISION INTERNATIONAL, INC.
WALNUT,  CA ,  US.
ROYALKING INDUSTRIAL CORP.
TAIPEI,  TW.
Manufacturer;  
ROYALKING INDUSTRIAL CORP.
TAIPEI,  TW.
ROYCE INT.L EYEWEAR, INC.
MORRIS,  NY,  US.
Initial Importer;  
ROYCE INT.L EYEWEAR, INC.
MORRIS,  NY ,  US.
ROYCE MEDICAL
CAMARILLO,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
OSSUR H/F
110 REYKJAVIK,  IC.
ROYDENT DENTAL PRODUCTS
JOHNSON CITY,  TN,  US.
Initial Importer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
ROYSON ENGIN CO.
HATBORO,  PA,  US.
Manufacturer;  
ROYSON ENGIN CO.
HATBORO,  PA ,  US.
ROZIN OPTICAL INTERNATIONAL, LLC
MIAMI,  FL,  US.
Initial Importer;  
ROZIN OPTICAL INTERNATIONAL, LLC
MIAMI,  FL ,  US.
ROZINN ELECTRONICS, INC.
GLENDALE,  NY,  US.
Manufacturer;  
ROZINN ELECTRONICS, INC.
GLENDALE,  NY ,  US.
RPI GROUP LLC
BRONX,  NY,  US.
Initial Importer;  
RPI GROUP LLC
BRONX,  NY ,  US.
RPX MEDICAL PRODUCTS
HOUSTON,  TX,  US.
Initial Importer;  
RENAISSANCE INVESTMENTS, LTD.
SPRING,  TX ,  US.

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Last Modified: 29 April 2006
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