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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
POLIDENT D.D., DENTAL PRODUCTS INDUSTRY
VOLCJA DRAGA,  SI.
Manufacturer;  
POLIDENT D.D., DENTAL PRODUCTS INDUSTRY
VOLCJA DRAGA,  SI.
POLIDENT P.O. DENTAL PRODUCTS INDUSTRY
VOLCJA DRAGA,  SI.
Unregistered Foreign Lister;  
POLIDENT D.D., DENTAL PRODUCTS INDUSTRY
VOLCJA DRAGA,  SI.
POLIFORCE
SAN DIEGO,  CA,  US.
Initial Importer;  
POLIFORCE
SAN DIEGO,  CA ,  US.
POLINELLI S.R.L.
DAVERIO VA,  IT.
Manufacturer;  
POLINELLI S.R.L.
DAVERIO VA,  IT.
POLK VOCATIONAL SERVICES
COLUMBUS,  NC,  US.
Contract Manufacturer;  
POLK VOCATIONAL SERVICES
COLUMBUS,  NC ,  US.
POLLAK (INTL.), LTD.
ROSH HA'AYIN,  IS.
Manufacturer;  
POLLAK (INTL.), LTD.
ROSH HA'AYIN,  IS.
POLLAK FOOD DIST., INC.
EAST CLEVELAND,  OH,  US.
Initial Importer;  
POLLAK FOOD DIST., INC.
EAST CLEVELAND,  OH ,  US.
POLLUX ENDOSCOPY, INC.
PLANT CITY,  FL,  US.
Initial Importer;  
POLLUX ENDOSCOPY, INC.
PLANT CITY,  FL ,  US.
POLO CUSTOM PRODUCTS
MONTICELLO,  IA,  US.
Manufacturer;  
M-C IND., INC.
TOPEKA,  KS ,  US.
POLTECO, INC.
HAYWARD,  CA,  US.
Manufacturer;  
POLTECO, INC.
HAYWARD,  CA ,  US.
POLY IMPLANTS PROTHESES
LA SEYNE-SUR-MER,  FR.
Manufacturer;  
POLY IMPLANTS PROTHESES
LA SEYNE-SUR-MER,  FR.
POLY MEDICURE LTD.
NEW DELHI,  IN.
Manufacturer;  
POLY MEDICURE LTD.
NEW DELHI,  IN.
POLY PROFIT INDUSTRIAL CO., LTD.
FO TAN, SHATIN,  HK.
Manufacturer;  
POLY PROFIT INDUSTRIAL CO., LTD.
FO TAN, SHATIN,  HK.
POLY SCIENTIFIC RESEARCH & DEVELOPMENT CORP.
BAYSHORE,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
POLY SCIENTIFIC RESEARCH & DEVELOPMENT CORP.
BAYSHORE,  NY ,  US.
POLY SHIELD INDUSTRIES (MALAYSIA) SDN. BHD.
KUALA LUMPUR,  MY.
Contract Manufacturer;   Manufacturer;  
POLY SHIELD INDUSTRIES (MALAYSIA) SDN. BHD.
KUALA LUMPUR,  MY.
POLY SUN CO., LTD.
BANGBUATHONG, NONTHABURI,  TH.
Manufacturer;  
POLY SUN CO., LTD.
BANGBUATHONG, NONTHABURI,  TH.
POLYCHROME MEDICAL
BROOKLYN CENTER,  MN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
POLYCHROME MEDICAL
BROOKLYN CENTER,  MN ,  US.
POLYCOM INC.
ANDOVER,  MA,  US.
Manufacturer;  
POLYCOM INC.
PLEASANTON,  CA ,  US.
POLYCONVERSIONS, INC.
RANTOUL,  IL,  US.
Contract Manufacturer;   Manufacturer;  
POLYCONVERSIONS, INC
RANTOUL,  IL ,  US.
POLYCORE OPTICAL (M) SDN BHD
SENAI, JOHOR,  MY.
Manufacturer;  
POLYCORE OPTICAL (M) SDN BHD
SENAI, JOHOR,  MY.
POLYCORE OPTICAL PTE LTD.
SINGAPORE,  SN.
Manufacturer;  
POLYCORE OPTICAL PTE LTD.
SINGAPORE,  SN.
POLYDENTIA S.A.
MEZZOVICO,  SZ.
Manufacturer;  
POLYDENTIA S.A.
MEZZOVICO,  SZ.
POLYDIAGNOST GMBH
PFAFFENHOFEN,  GM.
Foreign Exporter;   Manufacturer;   Specification Developer;  
POLYDIAGNOST GMBH
PFAFFENHOFEN,  GM.
POLY-FLEX CIRCUITS, LTD.
NEWPORT, ISLE OF WRIGHT,  UK.
Contract Manufacturer;   Manufacturer;  
POLYFLEX CIRCUITS, INC.
NEWPORT, ISLE OF WIGHT,  UK.
POLYGANICS BV
GRONINGEN,  NL.
Manufacturer;  
POLYGANICS BV
GRONINGEN,  NL.
POLYGELL LLC.
WHIPPANY,  NJ,  US.
Manufacturer;  
POLYGELL LLC.
WHIPPANY,  NJ ,  US.
POLYGENEX INTL., INC.
CARY,  NC,  US.
Contract Manufacturer;   Manufacturer;  
POLYGENEX INTL., INC.
CARY,  NC ,  US.
POLYGREEN (HK) CO., LTD.
KWUN TONG, HONG KONG,  CH.
Manufacturer;  
K-JUMP HEALTH CO., LTD.
TAIPEI HSIEN,  TW.
POLYGREEN ELECTRONIC MANUFACTORY
DONGGUAN, GUANG DONG,  CH.
Manufacturer;  
K-JUMP HEALTH CO., LTD.
TAIPEI HSIEN,  TW.
POLYLITE TAIWAN CO., LTD.
TAIPEI,  TW.
Manufacturer;  
POLYLITE TAIWAN CO., LTD.
TAIPEI,  TW.
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
XIAMEN,  CH.
Manufacturer;  
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
XIAMEN,  CH.
POLYMEDCO, INC.
CORTLANDT MANOR,  NY,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
POLYMEDCO, INC.
CORTLANDT MANOR,  NY ,  US.
POLYMEDCO, INC.
CORTLANDT MANOR,  NY,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
POLYMEDCO, INC.
CORTLANDT MANOR,  NY ,  US.
POLYMEDIC PTY LTD
ASHMORE QLD,  AS.
Foreign Exporter;   Manufacturer;  
POLYCANE AUSTRALIA PTY LTD
ASHMORE QLD,  AS.
POLYMEDICS N.V.
KREDIET BANK OVERPELT,  BE.
Manufacturer;  
POLYMEDICS N.V.
KREDIET BANK OVERPELT,  BE.
POLYMER CONCEPTS, INC.
MENTOR,  OH,  US.
Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
POLYMER CONCEPTS, INC.
MENTOR,  OH ,  US.
POLYMER CONVERSIONS INC.
ORCHARD PARK,  NY,  US.
Contract Manufacturer;  
POLYMER CONVERSIONS INC.
ORCHARD PARK,  NY ,  US.
POLYMER SCIENCE, INC.
MONTICELLO,  IN,  US.
Contract Manufacturer;  
POLYMER SCIENCE, INC.
MONTICELLO,  IN ,  US.
POLYMER TECHNOLOGY SYSTEMS, INC.
INDIANAPOLIS,  IN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Repackager/Relabeller;  
POLYMER TECHNOLOGY SYSTEMS, INC.
INDIANAPOLIS,  IN ,  US.
POLYMEREX MEDICAL CORP.
SAN DIEGO,  CA,  US.
Contract Manufacturer;   Manufacturer;  
POLYMEREX MEDICAL CORP.
SAN DIEGO,  CA ,  US.

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Last Modified: 29 April 2006
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