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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
PHONIC EAR, INC.
PETALUMA,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
WILLIAM DEMANT HOLDINGS, A/S
SMORUM,  DA.
PHOTO MEDEX, INC.
CARLSBAD,  CA,  US.
Manufacturer;  
PHOTO MEDEX, INC.
CARLSBAD,  CA ,  US.
PHOTO THERAPEUTICS LIMITED
ALTRINCHAM, CHESHIRE,  UK.
Manufacturer;  
PHOTO THERAPEUTICS LIMITED
ALTRINCHAM, CHESHIRE,  UK.
PHOTO THERAPEUTICS, INC.
LAKE FOREST,  CA,  US.
Initial Importer;  
PHOTO THERAPEUTICS LIMITED
ALTRINCHAM, CHESHIRE,  UK.
PHOTOMAX INDUSTRIAL CO., LTD.
TAIPEI,  TW.
Manufacturer;  
PHOTOMAX INDUSTRIAL CO., LTD.
TAIPEI,  TW.
PHOTONICS SERVICE GROUP, INC.
QUARTZ HILL,  CA,  US.
Initial Importer;  
PHOTONICS SERVICE GROUP, INC.
QUARTZ HILL,  CA ,  US.
PHOTOPROTECTIVE TECHNOLOGIES
SAN ANTONIO,  TX,  US.
Initial Importer;   Specification Developer;  
PHOTOPROTECTIVE TECHNOLOGIES
SAN ANTONIO,  TX ,  US.
PHOTOTHERAPY "UV" ASSOC.
LEXINGTON,  SC,  US.
Manufacturer;  
PHOTOTHERAPY "UV" ASSOC.
LEXINGTON,  SC ,  US.
PHOTO-THERM
TRENTON,  NJ,  US.
Manufacturer;  
PHOTO-THERM
TRENTON,  NJ ,  US.
PHOXXOR, INC.
MOBILE,  AL,  US.
Specification Developer;  
PHOXXOR, INC.
MOBILE,  AL ,  US.
PHP USA, INC
PEACHTREE CITY,  GA,  US.
Initial Importer;  
PERFORMANCE HEALTH PRODUCTS LTD
PYLE, MID GLAM,  UK.
PHS CUSTOM PACKAGING
TEMECULA,  CA,  US.
Repackager/Relabeller;  
PROFESSIONAL HOSPITAL SUPPLY, INC.
TEMECULA,  CA ,  US.
PHS MEDICAL GMBH
KAUFUNGEN,  GM.
Contract Manufacturer;  
PHS MEDICAL GMBH
KAUFUNGEN,  GM.
PHYSICAL RESEARCH CO.
CHARLTON,  MA,  US.
Manufacturer;  
PHYSICAL RESEARCH CO.
CHARLTON,  MA ,  US.
PHYSICIAN ENGINEERED PRODUCTS, INC.
FRYEBURG,  ME,  US.
Manufacturer;  
PHYSICIAN ENGINEERED PRODUCTS, INC.
FRYEBURG,  ME ,  US.
PHYSICIAN INDUSTRIES, INC.
SALT LAKE CITY,  UT,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PHYSICIAN INDUSTRIES, INC.
SALT LAKE CITY,  UT ,  US.
PHYSICIANS FORMULA INC.
AZUSA,  CA,  US.
Initial Importer;  
PFI HOLDINGS CORP.
AZUSA,  CA ,  US.
PHYSICIANS SURGEONS PURCHASING GROUP
LOS ANGELES,  CA,  US.
Initial Importer;  
PHYSICIANS SURGEONS PURCHASING GROUP
LOS ANGELES,  CA ,  US.
PHYSIOCAM LLC
BAY HARBOR ISLANDS,  FL,  US.
Initial Importer;  
PHYSIOMINS INTERNATIONAL
VALENCE, DROME,  FR.
PHYSIODYNAMICS, INC.
CENTENNIAL,  CO,  US.
Manufacturer;  
PHYSIODYNAMICS, INC.
CENTENNIAL,  CO ,  US.
PHYSIO-DYNE INSTRUMENT CORP.
QUOGUE,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PHYSIO-DYNE INSTRUMENT CORP.
QUOGUE,  NY ,  US.
PHYSIOMED ELEKTROMEDIZIN AG
SCHNAITTACH/LAIPERSDORF,  GM.
Manufacturer;  
PHYSIOMED ELEKTROMEDIZIN AG
SCHNAITTACH/LAIPERSDORF,  GM.
PHYSIOMED NORTH AMERICA
FARMERVILLE,  LA,  US.
Initial Importer;  
PHYSIOMED NORTH AMERICA
FARMERVILLE,  LA ,  US.
PHYSIOMEDICS MANUFACTURING, LLC
MINNETONKA,  MN,  US.
Manufacturer;  
PHYSIOMEDICS MANUFACTURING, LLC
MINNETONKA,  MN ,  US.
PHYSIOMINS INTERNATIONAL
VALENCE, DROME,  FR.
Manufacturer;  
PHYSIOMINS INTERNATIONAL
VALENCE, DROME,  FR.
PHYSION S.R.L.
MEDOLLA (MO),  IT.
Contract Manufacturer;  
PHYSION S.R.L.
MEDOLLA (MO),  IT.
PHYSITEMP INSTRUMENTS, INC.
CLIFTON,  NJ,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
PHYSITEMP INSTRUMENTS, INC.
CLIFTON,  NJ ,  US.
PHYTATEK LABORATORIES, INC.
SANTEE,  CA,  US.
Manufacturer;  
PHYTATEK LABORATORIES, INC.
SANTEE,  CA ,  US.
PHYTOLAB S.L.
COLMENAR VIEJO, MADRID,  SP.
Manufacturer;  
PHYTOLAB S.L.
COLMENAR VIEJO, MADRID,  SP.
PI DIRECT INC.
HILLSDALE,  NJ,  US.
Initial Importer;  
PI DIRECT INC.
HILLSDALE,  NJ ,  US.
PI PROFESSIONAL THERAPY PRODUCTS
ATHENS,  TN,  US.
Contract Manufacturer;   Manufacturer;  
PI, INC.
ATHENS,  TN ,  US.
PIAZZA OPTICAL CORP.
HIALEAH GARDENS,  FL,  US.
Initial Importer;  
PIAZZA OPTICAL CORP.
HIALEAH GARDENS,  FL ,  US.
PICIS INC.
WAKEFIELD,  MA,  US.
Initial Importer;  
PICIS INC.
WAKEFIELD,  MA ,  US.
PICSEE, INC.
ROSEVILLE,  CA,  US.
Initial Importer;  
PICSEE, INC.
ROSEVILLE,  CA ,  US.
PIE FEET COMPANY, INC.
MAUMEE,  OH,  US.
Initial Importer;   Specification Developer;  
PIE FEET COMPANY, INC.
MAUMEE,  OH ,  US.
PIE IMPORT EXPORT, INC.
NEW YORK,  NY,  US.
Initial Importer;  
PIE IMPORT EXPORT, INC.
NEW YORK,  NY ,  US.
PIE MEDICAL EQUIPMENT B.V.
MAASTRICHT,  NL.
Manufacturer;  
PIE MEDICAL EQUIPMENT B.V.
MAASTRICHT,  NL.
PIE MEDICAL IMAGING B.V.
MAASTRICHT,  NL.
Manufacturer;  
PIE MEDICAL IMAGING B.V.
MAASTRICHT,  NL.
PIE MEDICAL INTL., INC.
DULUTH,  GA,  US.
Specification Developer;  
PIE MEDICAL INTL., INC.
DULUTH,  GA ,  US.
PIEDMONT SPORTS MEDICINE COMPLEX
MACON,  GA,  US.
Initial Importer;   Specification Developer;  
PIEDMONT SPORTS MEDICINE COMPLEX
MACON,  GA ,  US.

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Last Modified: 29 April 2006
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