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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
PAUL H. GESSWEIN & CO.
BRIDGEPORT,  CT,  US.
Initial Importer;  
PAUL H. GESSWEIN & CO.
BRIDGEPORT,  CT ,  US.
PAUL HARTMANN AG
HEIDENHEIM,  GM.
Manufacturer;  
PAUL HARTMANN AG
HEIDENHEIM,  GM.
PAUL HARTMANN QINGDAO MEDICAL COMPANY
JIAONON, QINGDAO,  CH.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
PAUL HARTMANN AG
HEIDENHEIM,  GM.
PAUL INSTRUMENTS (INDIA)
CALCUTTA,  IN.
Manufacturer;  
PAUL INSTRUMENTS (INDIA)
CALCUTTA,  IN.
PAUL LOSENBECK GMBH CO. KG.
SOLINGEN,  GM.
Manufacturer;  
PAUL LOSENBECK GMBH CO. KG.
SOLINGEN,  GM.
PAUL MARIENFELD GMBH & CO. KG.
LAUDA-KOENIGSHOFEN,  GM.
Foreign Exporter;   Manufacturer;  
PAUL MARIENFELD GMBH & CO. KG.
LAUDA-KOENIGSHOFEN,  GM.
PAUL PESCHKE GMBH
LEIBERTINGEN,  GM.
Unregistered Foreign Lister;  
PAUL PESCHKE GMBH
LEIBERTINGEN,  GM.
PAUL SMITH, INC.
NEW YORK,  NY,  US.
Initial Importer;  
PAUL SMITH, INC.
NEW YORK,  NY ,  US.
PAUL STENGELIN KG.
TUTTLINGEN,  GM.
Manufacturer;  
PAUL STENGELIN KG.
TUTTLINGEN,  GM.
PAUL TAYLOR EYEWEAR PTY LTD
SYDNEY N.S.W.,  AS.
Specification Developer;  
PAUL TAYLOR EYEWEAR PTY LTD
SYDNEY N.S.W.,  AS.
PAULDRACH MEDICAL GMBH
GARBSEN,  GM.
Unregistered Foreign Lister;  
PAULDRACH MEDICAL GMBH
GARBSEN,  GM.
PAULINE RAYMOND-MARTIMBEAU, MD
HOUSTON,  TX,  US.
Initial Importer;  
PAULINE RAYMOND-MARTIMBEAU, MD
HOUSTON,  TX ,  US.
PAUSCH LLC
TINTON FALLS,  NJ,  US.
Initial Importer;   Manufacturer;  
PAUSCH LLC
TINTON FALLS,  NJ ,  US.
PAVILION INVESTMENT LTD.
HUNG HOM,  HK.
Foreign Exporter;  
PAVILION INVESTMENT LTD.
BROOKLYN,  NY ,  US.
PAVIS VARESE S.R.L.
BUGUGGIATE,  IT.
Manufacturer;  
PAVIS VARESE S.R.L.
BUGUGGIATE,  IT.
PAXTON COMPANY LTD.
KAOHSIUNG,  TW.
Manufacturer;  
PAXTON COMPANY LTD.
KAOHSIUNG,  TW.
PAXXONE ENT. CO., LTD.
SHIHLIN, TAIPEI CITY,  TW.
Manufacturer;  
PAXXONE ENT. CO., LTD.
SHIHLIN, TAIPEI CITY,  TW.
PAYLESS SHOE SOURCE WORLDWIDE, INC.
TOPEKA,  KS,  US.
Initial Importer;  
PAYLESS SHOE SOURCE WORLDWIDE, INC.
TOPEKA,  KS ,  US.
PAYLESS WHOLESALE, INC.
MASPETH,  NY,  US.
Initial Importer;  
PAYLESS WHOLESALE, INC.
MASPETH,  NY ,  US.
PAYNESVILLE AREA HOSPITAL
PAYNESVILLE,  MN,  US.
Initial Importer;  
PAYNESVILLE AREA HOSPITAL
PAYNESVILLE,  MN ,  US.
PAYTON SCIENTIFIC, INC.
BUFFALO,  NY,  US.
Initial Importer;   Manufacturer;  
PAYTON SCIENTIFIC, INC.
BUFFALO,  NY ,  US.
PB MEDICAL LTD
WORCESTER, WORCESTERSHIRE,  UK.
Manufacturer;  
PB MEDICAL LTD
WORCESTER, WORCESTERSHIRE,  UK.
PBC INT'L.
OXNARD,  CA,  US.
Initial Importer;  
PBC INT'L.
OXNARD,  CA ,  US.
PBN MEDICALS DENMARK A/S
STENLOESE,  DA.
Contract Manufacturer;  
MANAN MEDICAL PRODUCTS, INC.
WHEELING,  IL ,  US.
PBR, INC.
HARTLEY,  IA,  US.
Initial Importer;  
PBR, INC.
HARTLEY,  IA ,  US.
PCI TECHNOLOGY
DALLAS,  TX,  US.
Contract Manufacturer;  
PCI TECHNOLOGY
DALLAS,  TX ,  US.
PCK ELECTRONIC INDUSTRY & TRADE CO., LTD.
ANKARA,  TU.
Manufacturer;  
PCK ELECTRONIC INDUSTRY & TRADE CO., LTD.
ANKARA,  TU.
PCN, INC.
TAUNTON,  MA,  US.
Manufacturer;  
PCN, INC.
TAUNTON,  MA ,  US.
PDC MACHINE, INC.
ROWLEY,  MA,  US.
Contract Manufacturer;  
PDC MACHINE, INC.
ROWLEY,  MA ,  US.
PDG PRODUCT DESIGN GROUP, INC.
VANCOUVER, BC,  CA.
Manufacturer;  
PDG PRODUCT DESIGN GROUP, INC.
VANCOUVER, BC,  CA.
PDQ PRECISION INC.
NATIONAL CITY,  CA,  US.
Initial Importer;  
PDQ PRECISION INC.
NATIONAL CITY,  CA ,  US.
PDT, INC.
MISSOULA,  MT,  US.
Manufacturer;  
PDT, INC.
MISSOULA,  MT ,  US.
PDZ-EUROPA LTD.
RUDHEATH, NORTHWICH, CHESHIRE,  UK.
Manufacturer;   Specification Developer;  
PDZ-EUROPA LTD.
RUDHEATH, NORTHWICH, CHESHIRE,  UK.
PE & LE ENTERPRISE LTD.
TAIPEI HSIEN,  TW.
Manufacturer;  
PE & LE ENTERPRISE LTD.
TAIPEI HSIEN,  TW.
PE INTERNATIONAL/PE IMPORTING & EXPORTING INC.
FREMONT,  CA,  US.
Initial Importer;  
PE INTERNATIONAL/PE IMPORTING & EXPORTING INC.
FREMONT,  CA ,  US.
PEACE MEDICAL, INC.
ORANGE,  NJ,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PEACE MEDICAL, INC.
ORANGE,  NJ ,  US.
PEACHTREE PLAYTHINGS (HK) LTD.
TSIMSHATSUI, KOWLOON,  HK.
Manufacturer;  
SOUTHERN STATES MARKETING
MARIETTA,  GA ,  US.
PEACOCK ENGINEERING COMPANY
ITASCA,  IL,  US.
Repackager/Relabeller;  
PEACOCK ENGINEERING COMPANY
GENEVA,  IL ,  US.
PEAK ENTERPRISES, INC.
SARASOTA,  FL,  US.
Specification Developer;  
PEAK ENTERPRISES, INC.
SARASOTA,  FL ,  US.
PEAK INTERNATIONAL
SHENZHEN,  CH.
Contract Manufacturer;  
PEAK INTERNATIONAL
SHENZHEN,  CH.

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Last Modified: 29 April 2006
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