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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
PRIME MEDICAL, INC.
HWASEONG-SHI, GYEONGGI-DO,  KS.
Manufacturer;   Specification Developer;  
PRIME MEDICAL, INC.
HWASEONG-SHI, GYEONGGI-DO,  KS.
PRIME MEDICAL, INC.
PAXTON,  MA,  US.

PRIME MEDICAL, INC.
PAXTON,  MA ,  US.
PRIME MEDITECH CORP.
SEOUL,  KS.
Manufacturer;  
PRIME MEDITECH CORP.
SEOUL,  KS.
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
NORTH VANCOUVER,  CA.
Manufacturer;   Repackager/Relabeller;  
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
NORTH VANCOUVER,  CA.
PRIME RESOURCES CORP.
BRIDGEPORT,  CT,  US.
Initial Importer;  
PRIME RESOURCES CORP.
BRIDGEPORT,  CT ,  US.
PRIME SOURCE HEALTHCARE SYSTEMS, INC.
DEERFIELD,  IL,  US.
Initial Importer;  
PRIME SOURCE HEALTHCARE SYSTEMS, INC.
DEERFIELD,  IL ,  US.
PRIME TEST CORPORATION
LANTANA,  FL,  US.
Contract Manufacturer;  
PRIME TEST CORPORATION
LANTANA,  FL ,  US.
PRIME WAY COMPANIES LTD.
WELLAND, ONTARIO,  CA.
Manufacturer;  
PRIME WAY COMPANIES LTD.
WELLAND, ONTARIO,  CA.
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
HALBERSTADT,  GM.
Manufacturer;  
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
HALBERSTADT,  GM.
PRIMED INSTRUMENTS, INC.
MISSISSAUGA, ONTARIO,  CA.
Manufacturer;  
PRIMED INSTRUMENTS, INC.
MISSISSAUGA, ONTARIO,  CA.
PRIMED LIYANG MEDICAL PRODUCTS MANUFACTURING CO.,
LIYANG, JIANGSU,  CH.
Manufacturer;  
PRIMELINE MEDICAL PRODUCTS, INC.
EDMONTON, ALBERTA,  CA.
PRIMELINE MEDICAL PRODUCTS, INC.
EDMONTON, ALBERTA,  CA.
Manufacturer;   Specification Developer;  
PRIMELINE MEDICAL PRODUCTS, INC.
EDMONTON, ALBERTA,  CA.
PRIMERA LABORATORIES, LLC
GARLAND,  TX,  US.
Contract Manufacturer;   Manufacturer;  
PRIMERA LABORATORIES, LLC
GARLAND,  TX ,  US.
PRIMESTAR INSTRUMENTS
SIALKO, PUNJAB,  PK.
Manufacturer;  
PRIMESTAR INSTRUMENTS
SIALKOT, PUNJAB,  PK.
PRIMESYN LAB INC.
MONMOUTH,  NJ,  US.
Manufacturer;  
PRIMESYN LAB INC.
MONMOUTH,  NJ ,  US.
PRIMO, INC.
TYRONE,  GA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
PRIMO, INC.
TYRONE,  GA ,  US.
PRIMUS CORP.
KANSAS CITY,  MO,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
TRINITY BIOTECH, PLC
CO. WICKLOW,  EI.
PRIMUS GLOVES PRIVATE LTD.
KAKKANAD, COCHIN, KERALA,  IN.
Manufacturer;   Specification Developer;  
PRIMUS GLOVES PRIVATE LTD.
KAKKANAD, COCHIN, KERALA,  IN.
PRIMUS STERILIZER CO., INC.
GREAT BEND,  KS,  US.
Manufacturer;  
PRIMUS STERILIZER CO., INC.
OMAHA,  NE ,  US.
PRIMUS STERILIZER CO., INC.
OMAHA,  NE,  US.
Specification Developer;  
PRIMUS STERILIZER CO., INC.
OMAHA,  NE ,  US.
PRINCE & IZANT NUTEC METAL JOINING
CLEVELAND,  OH,  US.
Manufacturer;  
PRINCE & IZANT NUTEC METAL JOINING
CLEVELAND,  OH ,  US.
PRINCE FASHION CO.
DAEGU,  KS.
Manufacturer;  
PRINCE FASHION CO.
DAEGU,  KS.
PRINCE MEDICAL, INC.
WILLISTON,  VT,  US.
Manufacturer;  
PRINCE S.A.
ERCUIS,  FR.
PRINCE OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
PRINCE OPTICAL CO.
DAEGU,  KS.
PRINCE SPORTS, INC.
BORDENTOWN,  NJ,  US.
Initial Importer;  
PRINCE SPORTS, INC.
BORDENTOWN,  NJ ,  US.
PRINCESS CREATION CO., LTD. THAILAND
BANGKAPI, BANGKOK,  TH.
Unregistered Foreign Lister;  
PRINCESS CREATION CO., LTD. THAILAND
BANGKAPI, BANGKOK,  TH.
PRINCETON BIOMEDITECH CORP.
MONMOUTH JUNCTION,  NJ,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
PRINCETON BIOMEDITECH CORP.
MONMOUTH JUNCTION,  NJ ,  US.
PRINCETON LABORATORY SERVICES, LLC
KEASBEY,  NJ,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
PRINCETON LABORATORY SERVICES, LLC
KEASBEY,  NJ ,  US.
PRINCETON MEDICAL GROUP, INC.
MT. PLEASANT,  SC,  US.
Initial Importer;  
PRINCETON MEDICAL GROUP, INC.
MT. PLEASANT,  SC ,  US.
PRINCETON PARTNERS/DEVCOM
PRINCETON,  NJ,  US.
Specification Developer;  
PRINCETON PARTNERS/DEVCOM
PRINCETON,  NJ ,  US.
PRINCETON SEPARATIONS, INC.
FREEHOLD,  NJ,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PRINCETON SEPARATIONS, INC.
FREEHOLD,  NJ ,  US.
PRINCETON TECHNOLOGY CORP.
HUDSON,  NH,  US.
Contract Manufacturer;  
PRINCETON TECHNOLOGY CORP.
HUDSON,  NH ,  US.
PRINCIPAL GROUP LLC, SPORTS EQUIPMENT DIVISION
LANCASTER,  PA,  US.
Specification Developer;  
PRINCIPAL GROUP LLC, SPORTS EQUIPMENT DIVISION
LANCASTER,  PA ,  US.
PRINCIPLE BUSINESS ENT.
DUNBRIDGE,  OH,  US.
Manufacturer;  
PRINCIPLE BUSINESS ENT.
DUNBRIDGE,  OH ,  US.
PRINT ALL, INC.
BELLE CHASSE,  LA,  US.
Initial Importer;  
PRINT ALL, INC.
BELLE CHASSE,  LA ,  US.
PRINT DIRECTION, INC.
NORCROSS,  GA,  US.
Repackager/Relabeller;  
PRINT DIRECTION, INC.
NORCROSS,  GA ,  US.
PRINT MEDIA, INC.
MIAMI,  FL,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
PRINT MEDIA, INC.
MIAMI,  FL ,  US.
PRIO CORP.
BEAVERTON,  OR,  US.
Initial Importer;  
PRIO CORP.
BEAVERTON,  OR ,  US.
PRIORITY AIRFREIGHT, N.Y. LTD.
QUEENS,  NY,  US.
Initial Importer;  
PRIORITY AIRFREIGHT, N.Y. LTD.
QUEENS,  NY ,  US.
PRIORITY HEALTHCARE CORP.
GROVE CITY,  OH,  US.
Initial Importer;  
PRIORITY HEALTHCARE CORP.
LAKE MARY,  FL ,  US.

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Last Modified: 29 April 2006
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