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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
POLYMERS RECONSTRUCTIVE A/S
FARUM,  DA.
Unregistered Foreign Lister;  
POLYMERS RECONSTRUCTIVE A/S
FARUM,  DA.
POLYMERS, INC.
HOT SPRINGS,  AR,  US.
Manufacturer;  
POLYMERS, INC.
HOT SPRINGS,  AR ,  US.
POLY-OPTICAL PRODUCTS, INC.
IRVINE,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
TRIMEDYNE, INC.
IRVINE,  CA ,  US.
POLYPAZ, LTD.
YOKNEAM,  IS.
Foreign Exporter;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
TTMI INTERNATIONAL LTD.
LONG ISLAND CITY,  NY ,  US.
POLYSCIENCES, INC.
WARRINGTON,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
POLYSCIENCES, INC.
WARRINGTON,  PA ,  US.
POLYTECH INTERNATIONAL, INC.
CHINO,  CA,  US.
Initial Importer;  
POLYTECH INTERNATIONAL, INC.
CHINO,  CA ,  US.
POLYTEX DE MARACAY, C.A.
LA VICTORIA, AR,  VE.
Contract Manufacturer;   Manufacturer;  
POLYTEX DE MARACAY, C.A.
CARACAS, DF,  VE.
POLYVISION, INC.
RENO,  NV,  US.
Initial Importer;   Manufacturer;  
POLYCORE OPTICAL PTE LTD.
SINGAPORE,  SN.
POLYVUE DISTRIBUTION, INC.
PINOLE,  CA,  US.
Initial Importer;  
POLYVUE DISTRIBUTION, INC.
PINOLE,  CA ,  US.
POLYVUE TECHNOLOGIES, INC.
SACRAMENTO,  CA,  US.
Specification Developer;  
POLYVUE TECHNOLOGIES, INC.
SACRAMENTO,  CA ,  US.
POLYZEN, INC.
APEX,  NC,  US.
Contract Manufacturer;  
POLYZEN, INC.
APEX,  NC ,  US.
POMONA VALLEY WORKSHOP
MONTCLAIR,  CA,  US.
Contract Manufacturer;  
POMONA VALLEY WORKSHOP
MONTCLAIR,  CA ,  US.
PONDEROSA PRODUCTS.
HARRISON,  ME,  US.
Manufacturer;  
BOURDON P. SCRIBNER
HARRISON,  ME ,  US.
PONTUS INDUSTRIES LTD.
SHANGHAI,  CH.
Foreign Exporter;   Contract Manufacturer;  
PONTUS INDUSTRIES LTD.
SHANGHAI,  CH.
PONY EXPRESS CREATIONS, INC.
SAN DIEGO,  CA,  US.
Initial Importer;  
PONY EXPRESS CREATIONS, INC.
SAN DIEGO,  CA ,  US.
PONZINI S.P.A.
MISINTO(MILANO),  IT.
Manufacturer;  
PONZINI S.P.A.
MILAN,  IT.
POONGGOG MEDICAL INSTRUMENT CO.
SEOUL,  KS.
Foreign Exporter;   Manufacturer;  
POONGGOG MEDICAL INSTRUMENT CO.
SEOUL,  KS.
POP EYEWEAR INC.
FAIRFIELD,  NJ,  US.
Initial Importer;  
POP EYEWEAR INC.
FAIRFIELD,  NJ ,  US.
POPE PLASTICS, INC.
CANOGA PARK,  CA,  US.
Contract Manufacturer;  
POPE PLASTICS, INC.
CANOGA PARK,  CA ,  US.
POP-IN POP-OUT, INC.
KERRVILLE,  TX,  US.
Manufacturer;  
POP-IN POP-OUT, INC.
KERRVILLE,  TX ,  US.
POPP DCS, LLC.
GREENDALE,  WI,  US.
Initial Importer;  
POPP DENTAL LABORATORY INC.
GREENDALE,  WI ,  US.
POPPER & SONS, INC.
NEW HYDE PARK,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
POPPER & SONS, INC.
NEW HYDE PARK,  NY ,  US.
POPPER PRECISION INSTRUMENTS
LINCOLN,  RI,  US.
Manufacturer;  
POPPER & SONS, INC.
NEW HYDE PARK,  NY ,  US.
POPULAR MERCHANDISE USA, INC.
STAFFORD,  TX,  US.
Initial Importer;  
POPULAR MERCHANDISE USA, INC.
STAFFORD,  TX ,  US.
PORCHUCK LTD.
NEW YORK,  NY,  US.
Initial Importer;  
PORCHUCK LTD.
NEW YORK,  NY ,  US.
POREX CORP.
FAIRBURN,  GA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
EMDEON
ELMWOOD PARK,  NJ ,  US.
POREX SURGICAL, INC.
NEWNAN,  GA,  US.
Initial Importer;   Manufacturer;  
POREX CORPORATION
FAIRBURN,  GA ,  US.
PORGES S.A.
SARLAT,  FR.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
MENTOR CORP.
SANTA BARBARA,  CA ,  US.
PORI & ROWE ASSOC., INC.
PACIFICA,  CA,  US.
Manufacturer;  
PORI & ROWE ASSOC., INC.
PACIFICA,  CA ,  US.
POROUS MEDIA CORP.
ST. PAUL,  MN,  US.
Manufacturer;  
POROUS MEDIA CORP.
ST. PAUL,  MN ,  US.
PORPHYRIN PRODUCTS, INC.
LOGAN,  UT,  US.
Manufacturer;  
PORPHYRIN PRODUCTS, INC.
LOGAN,  UT ,  US.
PORSCHE CARS NORTH AMERICA, INC.
ATLANTA,  GA,  US.
Initial Importer;  
PORSCHE ENTERPRISES, INC.
LISLE,  IL ,  US.
PORSCHE DESIGN OF AMERICA
COSTA MESA,  CA,  US.
Initial Importer;  
PORSCHE LIZENZ-UND HANDELSGESELLSSCHFT MBH & CO. K
BISSINGEN,  GM.
PORSCHE INTL. LTD.
TAIPEI,  TW.
Manufacturer;  
PORSCHE INTL. LTD.
TAIPEI,  TW.
PORTABLE MEDICAL LABORATORIES, INC.
SOLANA BEACH,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PORTABLE MEDICAL LABORATORIES, INC.
SOLANA BEACH,  CA ,  US.
PORTACARE LLC
SPOKANE,  WA,  US.
Initial Importer;   Manufacturer;  
PORTACARE LLC
SPOKANE,  WA ,  US.
PORTAL INDUSTRIES, INC.
GRAFTON,  WI,  US.
Repackager/Relabeller;  
PORTAL INDUSTRIES, INC.
GRAFTON,  WI ,  US.
PORTAL, INC.
LOGAN,  UT,  US.
Initial Importer;   Manufacturer;  
PORTAL, INC.
LOGAN,  UT ,  US.
PORTA-LUNG CO.
DENVER,  CO,  US.
Manufacturer;  
PORTA-LUNG CO.
DENVER,  CO ,  US.
PORTER INSTRUMENT CO., INC.
HATFIELD,  PA,  US.
Manufacturer;  
PARKER HANNIFIN CORPORATION - INSTRUMENTATION
CLEVELAND,  OH ,  US.

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Last Modified: 29 April 2006
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