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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
PLAXTRON INDUSTRIAL (M) SDN. BHD.
IPOH, PERAK,  MY.
Contract Manufacturer;   Manufacturer;  
PLAXTRON INDUSTRIAL (M) SDN. BHD.
IPOH, PERAK,  MY.
PLAYFULLY YOURS HONG KONG, LTD.
HK.
Unregistered Foreign Lister;  
PLAYFULLY YOURS HONG KONG, LTD.
NEW YORK,  NY ,  US.
PLAYTEX PRODUCTS, INC.
DOVER,  DE,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
PLAYTEX PRODUCTS, INC.
ALLENDALE,  NJ ,  US.
PLAYTEX PRODUCTS, INC.
SIDNEY,  OH,  US.
Repackager/Relabeller;  
PLAYTEX PRODUCTS, INC.
ALLENDALE,  NJ ,  US.
PLAYTEX PRODUCTS, INC.
WESTPORT,  CT,  US.
Specification Developer;  
PLAYTEX PRODUCTS, INC.
ALLENDALE,  NJ ,  US.
PLC MEDICAL SYSTEMS, INC.
FRANKLIN,  MA,  US.
Manufacturer;  
PLC MEDICAL SYSTEMS, INC.
FRANKLIN,  MA ,  US.
PLEASANT DRUG CO.
FALL RIVER,  MA,  US.
Initial Importer;  
J.J.S., INC.
FALL RIVER,  MA ,  US.
PLEASANT SURGICO
SIALKOT PAKISTAN,  PK.
Manufacturer;  
PLEASANT SURGICO
SIALKOT PAKISTAN,  PK.
PLEASURE LATEX PRODUCTS SDN. BHD.
JERAM, SELANGOR DARUL EHSAN,  MY.
Manufacturer;  
PLEASURE LATEX PRODUCTS SDN. BHD.
JERAM, SELANGOR DARUL EHSAN,  MY.
PLEOMORPHIC PRODUCT SALES, INC.
GLENDALE,  AZ,  US.
Initial Importer;  
SANUM-KEHLBECK GMBH & CO. KG
HOYA, NIEDERSACHSEN,  GM.
PLEXAR ASSOC., INC.
SOLON,  OH,  US.
Manufacturer;  
PLEXAR ASSOC., INC.
SOLON,  OH ,  US.
PLEXUS BIOMEDICAL INC.
WHITEVILLE,  TN,  US.
Manufacturer;  
PLEXUS BIOMEDICAL INC.
WHITEVILLE,  TN ,  US.
PLEXUS CORP (UK) LIMITED
MALDON, ESSEX,  UK.
Contract Manufacturer;  
PLEXUS SERVICES CORP.
NEENAH,  WI ,  US.
PLEXUS ELECTRONIC ASSEMBLY
CD.JUAREZ, CHIHUAHUA,  MX.
Contract Manufacturer;  
PLEXUS SERVICES CORP.
NEENAH,  WI ,  US.
PLEXUS ELECTRONIC ASSEMBLY
PENANG,  MY.
Contract Manufacturer;  
PLEXUS SERVICES CORP.
NEENAH,  WI ,  US.
PLEXUS ELECTRONIC ASSEMBLY
BUFFALO GROVE,  IL,  US.
Contract Manufacturer;  
PLEXUS SERVICES CORP.
NEENAH,  WI ,  US.
PLEXUS SERVICES CORP.
BOTHELL,  WA,  US.
Contract Manufacturer;  
PLEXUS SERVICES CORP.
NEENAH,  WI ,  US.
PLITEK, L.L.C.
DES PLAINES,  IL,  US.
Contract Manufacturer;  
PLITEK, L.L.C.
DES PLAINES,  IL ,  US.
PLURIBUS PRODUCTS, INC.
BROOKLYN,  NY,  US.
Manufacturer;  
PLURIBUS PRODUCTS, INC.
BROOKLYN,  NY ,  US.
PLURIMETER GONIO SYSTEM
LA CONVERSION,  SZ.
Unregistered Foreign Lister;  
PLURIMETER GONIO SYSTEM
LA CONVERSION,  SZ.
PLUS ORTHOPEDICS AG
AARAU,  SZ.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
PLUS ORTHOPEDICS AG
ROTKREUZ,  SZ.
PLUS ORTHOPEDICS AG
ROTKREUZ,  SZ.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
PLUS ORTHOPEDICS AG
ROTKREUZ,  SZ.
PLUS ORTHOPEDICS USA, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
PLUS ORTHOPEDICS USA, INC.
SAN DIEGO,  CA ,  US.
PLUSOPTIX GMBH
NUERNBERG, BAVARIA,  GM.
Manufacturer;  
PLUSOPTIX GMBH
NUERNBERG, BAVARIA,  GM.
PLYMOUTH RUBBER CO., LTD.
BANGKOK,  TH.
Manufacturer;  
PLYMOUTH RUBBER CO., LTD.
BANGKOK,  TH.
PM DEVICES, INC.
RICHMOND, BC,  CA.
Contract Manufacturer;   Manufacturer;  
PM DEVICES, INC.
RICHMOND, BC,  CA.
PM FROST GMBH - EYEWEAR & ACCESSORIES
SASBACH,  GM.
Manufacturer;  
PM FROST GMBH - EYEWEAR & ACCESSORIES
SASBACH,  GM.
PM GLOVES, INC.
CHINO,  CA,  US.
Initial Importer;  
PM GLOVES, INC.
CHINO,  CA ,  US.
PMC MEDICAL INDIA PVT. LTD.
NANI DAMAN, UNION TERRITORY,  IN.
Foreign Exporter;   Reprocessor of single-use devices;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
PREMIER MEDICAL CORPORATION
COLONIA,  NJ ,  US.
PMCG, INC.
SANATOGA,  PA,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
PMCG, INC.
SANATOGA,  PA ,  US.
PMI INDUSTRIES, INC.
MARIETTA,  GA,  US.
Initial Importer;  
PMI INDUSTRIES, INC.
MARIETTA,  GA ,  US.
PML FLIGHTLINK LTD.
ALTON,HAMPSHIRE,  UK.
Manufacturer;  
PML FLIGHTLINK, LTD.
ALTON,HAMPSHIRE,  UK.
PML MICROBIOLOGICALS
MISSISSAUGA, ONTARIO,  CA.
Manufacturer;  
PML MICROBIOLOGICALS
WILSONVILLE,  OR ,  US.
PML MICROBIOLOGICALS
WILSONVILLE,  OR,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
PML MICROBIOLOGICALS
WILSONVILLE,  OR ,  US.
PMT CORP.
CHANHASSEN,  MN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
PMT CORP.
CHANHASSEN,  MN ,  US.
PNEUMEX, INC.
SANDPOINT,  ID,  US.
Manufacturer;  
PNEUMEX, INC.
SANDPOINT,  ID ,  US.
PNEU-MOBILITY, INC.
ALLENTOWN,  PA,  US.
Manufacturer;  
PNEU-MOBILITY, INC.
ALLENTOWN,  PA ,  US.
PNI CORP.
SANTA ROSA,  CA,  US.
Initial Importer;   Specification Developer;  
PNI CORP.
SANTA ROSA,  CA ,  US.
PO WAH CO.,LTD.
WAN CHAI, HONG KONG,  CH.
Foreign Exporter;  
PO WAH CO.,LTD.
WAN CHAI,  HK.
POAMAX L.L.C.
POQUOSON,  VA,  US.
Specification Developer;  
POAMAX L.L.C.
POQUOSON,  VA ,  US.

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Last Modified: 29 April 2006
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