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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
PREVENTIVE DENTAL SPECIALTIES, INC.
WESTON,  WI,  US.
Specification Developer;  
PREVENTIVE DENTAL SPECIALTIES, INC.
WESTON,  WI ,  US.
PREVENTIVE DENTISTRY PRODUCTS, INC.
COSTA MESA,  CA,  US.
Manufacturer;  
PREVENTIVE DENTISTRY PRODUCTS, INC.
COSTA MESA,  CA ,  US.
PREVENTIVE TECHNOLOGIES, INC.
MATTHEWS,  NC,  US.
Manufacturer;   Specification Developer;  
PREVENTIVE TECHNOLOGIES, INC.
MATTHEWS,  NC ,  US.
PREXA INDUSTRIES
SIALKOT,  PK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PREXA INDUSTRIES
SIALKOT,  PK.
PRICE CHOPPER, INC.
ORLANDO,  FL,  US.
Initial Importer;  
PRICE CHOPPER, INC.
ORLANDO,  FL ,  US.
PRICE INVENA APS
COPENHAGEN K,  DA.
Manufacturer;  
PRICE INVENA APS
COPENHAGEN K,  DA.
PRICE LIGATING, INC.
MAPLE PLAIN,  MN,  US.
Manufacturer;   Specification Developer;  
PRICE LIGATING, INC.
MAPLE PLAIN,  MN ,  US.
PRICE WORLD
FLUSHING,  NY,  US.
Initial Importer;  
HAMANT MULLICK, PROPRIETOR
FLUSHING,  NY ,  US.
PRICE WORLD
BROOKLYN,  NY,  US.
Initial Importer;  
PRICE WORLD
BROOKLYN,  NY ,  US.
PRIDE C.A.S., INC.
NEW YORK,  NY,  US.
Initial Importer;  
PRIDE C.A.S., INC.
NEW YORK,  NY ,  US.
PRIDE INDUSTRIES
ROSEVILLE,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PRIDE INDUSTRIES
ROSEVILLE,  CA ,  US.
PRIDE MOBILITY PRODUCTS CORP.
DURYEA,  PA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
PRIDE MOBILITY PRODUCTS CORP.
EXETER,  PA ,  US.
PRIDE MOBILITY PRODUCTS CORP.
EXETER,  PA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
PRIDE MOBILITY PRODUCTS CORP.
EXETER,  PA ,  US.
PRIDE PRODUCTS CORP.
RONKONKOMA,  NY,  US.
Initial Importer;  
PRIDE PRODUCTS CORP.
RONKONKOMA,  NY ,  US.
PRIDECRAFT ENT.
ENTERPRISE,  AL,  US.
Initial Importer;   Manufacturer;  
STANDARD TEXTILE CO., INC.
CINCINNATI,  OH ,  US.
PRIDENT INTERNATIONAL INC.
YORK,  PA,  US.
Initial Importer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
PRIDENT INTERNATIONAL, INC.
SHANGHAI,  CH.
Foreign Exporter;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
PRIM S.A.
MOSTOLES, MADRID,  SP.
Unregistered Foreign Lister;  
PRIM S.A.
MOSTOLES, MADRID,  SP.
PRIM,S.A.
MOSTOLES,MADRID,  SP.
Manufacturer;  
PRIM,S.A.
MOSTOLES,MADRID,  SP.
PRIMA DENTAL GROUP
GLOUCESTER,  UK.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
S.S. WHITE GROUP LTD.
GLOUCESTER, ENGLAND,  UK.
PRIMACARE MEDICAL SUPPLIES, INC.
LINDEN,  NJ,  US.
Initial Importer;  
PRIMACARE MEDICAL SUPPLIES, INC.
LINDEN,  NJ ,  US.
PRIMARY CARE SOLUTIONS, INC.
ZEPHYRHILLS,  FL,  US.
Manufacturer;  
PRIMARY CARE SOLUTIONS, INC.
MOBILE,  AL ,  US.
PRIMARY MEDICAL CO., INC.
LARGO,  FL,  US.
Repackager/Relabeller;  
PRIMEDCO
LARGO,  FL ,  US.
PRIMARY VISION CARE, INC.
NEWARK,  OH,  US.
Manufacturer;  
PRIMARY VISION CARE, INC.
NEWARK,  OH ,  US.
PRIMATEC CORP.
TOKYO,  JA.
Repackager/Relabeller;  
PRIMATEC CORP.
TOKYO,  JA.
PRIMATEC, INC.
CLARKSVILLE,  TN,  US.
Specification Developer;  
PRIMATEC, INC.
CLARKSVILLE,  TN ,  US.
PRIMATECH MEDICAL SYSTEMS, INC.
OKLAHOMA CITY,  OK,  US.
Initial Importer;  
PRIMATECH MEDICAL SYSTEMS, INC.
OKLAHOMA CITY,  OK ,  US.
PRIMAX SURGICAL LIMITED
REDDITCH, WORCESTERSHIRE,  UK.
Specification Developer;  
STERIMEDIX LTD.
REDDITCH WORCESTERSHIRE,  UK.
PRIME ACCURATE, INC.
CHUNG LI, TAO YUAN SHIEN,  TW.
Manufacturer;  
PRIME ACCURATE, INC.
CHUNG LI, TAO YUAN SHIEN,  TW.
PRIME CARE MEDICAL SUPPLIES, INC.
HOLTSVILLE,  NY,  US.
Repackager/Relabeller;  
PRIME CARE MEDICAL SUPPLIES, INC.
HOLTSVILLE,  NY ,  US.
PRIME DENTAL MANUFACTURING, INC.
CHICAGO,  IL,  US.
Contract Manufacturer;   Manufacturer;  
PRIME DENTAL MANUFACTURING, INC.
CHICAGO,  IL ,  US.
PRIME DISTRIBUTORS LLC
BROOKLYN,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
PRIME DISTRIBUTORS LLC
BROOKLYN,  NY ,  US.
PRIME ENTERPRISES, INC.
MIAMI,  FL,  US.
Contract Manufacturer;  
PRIME ENTERPRISES, INC.
MIAMI,  FL ,  US.
PRIME HEALTH SUPPLY INC.
BROOKLYN,  NY,  US.
Initial Importer;  
PRIME HEALTH SUPPLY INC.
BROOKLYN,  NY ,  US.
PRIME HERBS CORPORATION
SUNNYVALE,  CA,  US.
Initial Importer;  
PRIME HERBS CORPORATION
SUNNYVALE,  CA ,  US.
PRIME INSTRUMENTS, INC.
RANDOLPH,  NJ,  US.
Initial Importer;  
PRIME INSTRUMENTS, INC.
RANDOLPH,  NJ ,  US.
PRIME INTERNATIONAL TRADERS, INC.
DEERFIELD BEACH,  FL,  US.
Initial Importer;  
PRIME INTERNATIONAL TRADERS, INC.
DEERFIELD BEACH,  FL ,  US.
PRIME MATERIALS CORP.
BATAVIA,  NY,  US.
Manufacturer;  
PRIME MATERIALS CORP.
BATAVIA,  NY ,  US.
PRIME MEDICAL PRODUCTS, INC.
ROUND LAKE PARK,  IL,  US.
Specification Developer;  
PRIME MEDICAL PRODUCTS, INC.
ROUND LAKE PARK,  IL ,  US.
PRIME MEDICAL SUPPLIES
SIALKOT, PUNJAB,  PK.
Manufacturer;  
PRIME MEDICAL SUPPLIES
SIALKOT, PUNJAB,  PK.

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Last Modified: 29 April 2006
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