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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
PENTAPHARM LTD.
BASEL, BASEL-STADT,  SZ.
Manufacturer;  
PENTAPHARM LTD.
BASEL, BASEL-STADT,  SZ.
PENTAVOX KFT.
BUDAPEST,  HU.
Manufacturer;  
PENTAVOX KFT.
BUDAPEST,  HU.
PENTAX CORP.
TOKYO,  JA.
Foreign Exporter;   Specification Developer;  
PENTAX CORP.
TOKYO,  JA.
PENTAX MEDICAL COMPANY
MONTVALE,  NJ,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;  
PENTAX MEDICAL COMPANY
MONTVALE,  NJ ,  US.
PENTAX TOHUKO CO. YAMAGATA FACTORY
YAMAGATA,  JA.
Contract Manufacturer;  
PENTAX CORP.
TOKYO,  JA.
PENTAX TOHUKO CO., LTD
MIYAGI,  JA.
Contract Manufacturer;  
PENTAX CORP.
TOKYO,  JA.
PENTAX VISION, INC.
MINNETONKA,  MN,  US.
Initial Importer;  
SEIKO OPTICAL PRODUCTS CO.,LTD
1-CHOME CHUO-KU, TOKYO,  JA.
PENTRON CERAMICS, INC
SOMERSET,  NJ,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IVOCLAR VIVADENT, INC.
AMHERST,  NY ,  US.
PENTRON CERAMICS, INC.
SOMERSET,  NJ,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
IVOCLAR VIVADENT, INC.
AMHERST,  NY ,  US.
PENTRON CLINICAL TECHNOLOGIES
WALLINGFORD,  CT,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
PENTRON CLINICAL TECHNOLOGIES
WALLINGFORD,  CT ,  US.
PENTRON LABORATORY TECHNOLOGIES
WALLINGFORD,  CT,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
PENTRON CORP.
WALLINGFORD,  CT ,  US.
PENTRONICS, INC.
SALT LAKE CITY,  UT,  US.
Contract Manufacturer;  
PENTRONICS, INC.
SALT LAKE CITY,  UT ,  US.
PENUMBRA, INC.
SAN LEANDRO,  CA,  US.
Manufacturer;  
PENUMBRA, INC.
SAN LEANDRO,  CA ,  US.
PEOPLE WITH STYLE.COM
PHILADELPHIA,  PA,  US.
Initial Importer;  
PEOPLE WITH STYLE.COM
PHILADELPHIA,  PA ,  US.
PEP BOYS
PHILADELPHIA,  PA,  US.
Initial Importer;  
PEP BOYS
PHILADELPHIA,  PA ,  US.
PEPIN MFG., INC.
LAKE CITY,  MN,  US.
Contract Manufacturer;  
PEPIN MFG., INC.
LAKE CITY,  MN ,  US.
PEPPER MEDICAL, INC.
WESTCHESTER,  PA,  US.
Repackager/Relabeller;  
PEPPER MEDICAL, INC.
WESTCHESTER,  PA ,  US.
PEPPER'S PERFORMANCE EYEWARE, INC.
PITTSBURGH,  PA,  US.
Initial Importer;  
PEPPER'S PERFORMANCE EYEWARE, INC.
PITTSBURGH,  PA ,  US.
PEPSI-COLA BOTTLING CO.
CORVALLIS,  OR,  US.
Initial Importer;  
NEON SPECIALTIES
CORVALLIS,  OR ,  US.
PER ANNUM, INC.
NEW YORK,  NY,  US.
Initial Importer;  
PER ANNUM, INC.
NEW YORK,  NY ,  US.
PER4MAX MEDICAL, LLC
GRAND PRAIRIE,  TX,  US.
Manufacturer;  
PER4MAX MEDICAL, LLC
GRAND PRAIRIE,  TX ,  US.
PERCELL BIOLYTICA AB
ASTORP, SKANE,  SW.
Manufacturer;  
PERCELL BIOLYTICA AB
ASTORP, SKANE,  SW.
PERCEPTIONS, LLC
OREM,  UT,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
PERCEPTIONS, LLC
OREM,  UT ,  US.
PERCEPTRONIX MEDICAL INC
VANCOUVER, BC,  CA.
Manufacturer;  
PERCEPTRONIX MEDICAL INC
VANCOUVER, BC,  CA.
PERCUDISC, INC.
NEW YORK,  NY,  US.
Specification Developer;  
PERCUDISC, INC.
NEW YORK,  NY ,  US.
PERCUSSIONAIRE CORP.
SAGLE,  ID,  US.
Manufacturer;  
PERCUSSIONAIRE CORP.
SAGLE,  ID ,  US.
PERCUTANEOUS SYSTEMS, INCORPORATED
MOUNTAIN VIEW,  CA,  US.
Manufacturer;  
PERCUTANEOUS SYSTEMS, INCORPORATED
MOUNTAIN VIEW,  CA ,  US.
PEREGO INDUSTRIA E COMERCIO DE LENTAS LTDA.
ARACATUBA, SAO PAULO,  BR.
Manufacturer;  
PEREGO INDUSTRIA E COMERCIO DE LENTAS LTDA.
ARACATUBA, SAO PAULO,  BR.
PEREGRINE SURGICAL LTD.
NEW BRITAIN,  PA,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
PEREGRINE SURGICAL LTD.
NEW BRITAIN,  PA ,  US.
PEREZ DISTRIBUTING CO.
NORTH HOLLYWOOD,  CA,  US.
Initial Importer;  
PEREZ DISTRIBUTING CO.
NORTH HOLLYWOOD,  CA ,  US.
PEREZ-CONDE, INC.
MIAMI,  FL,  US.
Initial Importer;  
PEREZ-CONDE, INC.
MIAMI,  FL ,  US.
PERFECSEAL, INC.
OSHKOSH,  WI,  US.
Manufacturer;  
CURWOOD, INC.
OSHKOSH,  WI ,  US.
PERFECT CARE
RICHMOND HILL,  NY,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PERFECT CARE
RICHMOND HILL,  NY ,  US.
PERFECT CHOICE TRADING, INC.
NEW YORK,  NY,  US.
Initial Importer;  
PERFECT CHOICE TRADING, INC.
NEW YORK,  NY ,  US.
PERFECT FIT INDUSTRIES, INC.
CHARLOTTE,  NC,  US.
Manufacturer;  
PERFECT FIT INDUSTRIES, INC.
CHARLOTTE,  NC ,  US.
PERFECT FIT, L.P.
HOUSTON,  TX,  US.
Manufacturer;  
DENTAL WEALTH, LLC.
HOUSTON,  TX ,  US.
PERFECT HEALTH NUTRIENTS, INC.
SOUTH EL MONTE,  CA,  US.
Initial Importer;  
PERFECT HEALTH NUTRIENTS, INC.
SOUTH EL MONTE,  CA ,  US.
PERFECT HEALTH SUPPLIES
ORLANDO,  FL,  US.
Initial Importer;  
PERFECT HEALTH SUPPLIES
ORLANDO,  FL ,  US.
PERFECT LATEX PVT. LTD.
DELHI,  IN.
Manufacturer;  
PERFECT LATEX PVT. LTD.
DELHI,  IN.
PERFECT MEDICAL INDUSTRY CO., LTD.
CHANG HWA HSIEN,  TW.
Contract Manufacturer;   Manufacturer;  
PERFECT MEDICAL INDUSTRY CO., LTD.
CHANG HWA HSIEN,  TW.

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Last Modified: 29 April 2006
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