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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
PRE PAK PRODUCTS, INC.
OCEANSIDE,  CA,  US.
Manufacturer;  
PRE PAK PRODUCTS, INC.
OCEANSIDE,  CA ,  US.
PREANALYTIX GMBH
HOMBRECHTIKON,  SZ.
Specification Developer;  
PREANALYTIX GMBH
HOMBRECHTIKON,  SZ.
PREAT CORP.
SANTA YNEZ,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
PREAT CORP.
SANTA YNEZ,  CA ,  US.
PREAT CORPORATION
SANTA YNEZ,  CA,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
PREAT CORPORATION
SANTA YNEZ,  CA ,  US.
PRECEPT MEDICAL PRODUCTS, INC.
AGUA PRIETA, SONORA,  MX.
Manufacturer;  
PRECEPT MEDICAL PRODUCTS, INC.
ARDEN,  NC ,  US.
PRECEPT MEDICAL PRODUCTS, INC.
ARDEN,  NC,  US.
Specification Developer;  
PRECEPT MEDICAL PRODUCTS, INC.
ARDEN,  NC ,  US.
PRECEPT MEDICAL PRODUCTS, INC.
CHILDERSBURG,  AL,  US.
Manufacturer;  
PRECEPT MEDICAL PRODUCTS, INC.
ARDEN,  NC ,  US.
PRECEPT MEDICAL PRODUCTS, INC.
DOUGLAS,  AZ,  US.
Manufacturer;  
PRECEPT MEDICAL PRODUCTS, INC.
ARDEN,  NC ,  US.
PRECIMED
COLUMBIA CITY,  IN,  US.
Contract Manufacturer;  
PRECIMED SA.
ORVIN,  SZ.
PRECIMED SA.
ORVIN,  SZ.
Manufacturer;   Specification Developer;  
PRECIMED SA.
ORVIN,  SZ.
PRECIMED, INC.
EXTON,  PA,  US.
Initial Importer;  
PRECIMED SA.
ORVIN,  SZ.
PRECIOUS LIFE SAVING PRODUCTS, INC.
HALIFAX, NOVA SCOTIA,  CA.
Manufacturer;  
PRECIOUS LIFE SAVING PRODUCTS, INC.
HALIFAX, NOVA SCOTIA,  CA.
PRECIOUS MOUNTAIN ENT. CORP.
TAIPEI,  TW.
Manufacturer;  
PRECIOUS MOUNTAIN ENT. CORP.
TAIPEI,  TW.
PRECISA INTL. CORP.
MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
PRECISA INTL. CORP.
MIAMI,  FL ,  US.
PRECISE DENTAL INTERNACIONAL S.A.C.V.
ZAPOPAN, JALISOO,  MX.
Manufacturer;  
PRECISE DENTAL PRODUCTS LTD.
CANOGA PARK,  CA ,  US.
PRECISE DENTAL PRODUCTS LTD.
CANOGA PARK,  CA,  US.
Initial Importer;  
PRECISE DENTAL PRODUCTS LTD.
CANOGA PARK,  CA ,  US.
PRECISE MEDICAL PRODUCTS, LTD.
SHLOMI,  IS.
Manufacturer;  
PRECISE MEDICAL PRODUCTS, LTD.
SHLOMI,  IS.
PRECISE METAL WORKS
AHMEDABAD,  IN.
Manufacturer;  
PRECISE METAL WORKS
AHMEDABAD,  IN.
PRECISE OPTICS
BAY SHORE,  NY,  US.
Manufacturer;  
PRECISE OPTICS
BAY SHORE,  NY ,  US.
PRECISE PLASTICS
FAIRVIEW,  PA,  US.
Manufacturer;  
PRECISE PLASTICS
FAIRVIEW,  PA ,  US.
PRECISE TECHNOLOGY, INC.
BUFFALO GROVE,  IL,  US.
Contract Manufacturer;  
PRECISION TECHNOLOGY, INC.
NORTH VERSAILLES,  PA ,  US.
PRECISE-PAK, INC.
DOVER,  NH,  US.
Contract Manufacturer;  
PRECISE-PAK, INC.
DOVER,  NH ,  US.
PRECISION ACOUSTICS IND., INC.
NEW YORK,  NY,  US.
Repackager/Relabeller;  
PRECISION ACOUSTICS IND., INC.
NEW YORK,  NY ,  US.
PRECISION ASSEMBLY CORP.
NORTHVALE,  NJ,  US.
Contract Manufacturer;  
PRECISION ASSEMBLY CORP.
NORTHVALE,  NJ ,  US.
PRECISION ASSEMBLY CORP.
WILLOW GROVE,  PA,  US.
Contract Manufacturer;  
PRECISION ASSEMBLY CORP.
WILLOW GROVE,  PA ,  US.
PRECISION BIOLOGIC INC.
DARTMOUTH, N.S.,  CA.
Manufacturer;  
PRECISION BIOLOGIC, INC.
DARTMOUTH, N.S.,  CA.
PRECISION BIOMETRICS, INC.
SAN CARLOS,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PRECISION BIOMETRICS, INC.
SAN CARLOS,  CA ,  US.
PRECISION CAST PLASTIC PARTS, LLC.
REDDING,  CA,  US.
Contract Manufacturer;   Manufacturer;  
PRECISION CAST PLASTIC PARTS, LLC.
REDDING,  CA ,  US.
PRECISION CONCEPTS COSTA RICA S.A.
ALAJUELA,  CS.
Contract Manufacturer;   Manufacturer;  
PRECISION CONCEPTS GROUP LLC
WINSTON-SALEM,  NC ,  US.
PRECISION CROWN & BRIDGE, INC.
HARRISON,  AR,  US.
Repackager/Relabeller;  
PRECISION CROWN & BRIDGE, INC.
HARRISON,  AR ,  US.
PRECISION DENTAL INT, INC.
CANOGA PARK,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
PRECISION DENTAL INT, INC.
CANOGA PARK,  CA ,  US.
PRECISION DENTAL LABORATORIES, INC.
FARGO,  ND,  US.
Manufacturer;  
PRECISION DENTAL LABORATORIES, INC.
FARGO,  ND ,  US.
PRECISION DYNAMICS CORP.
SAN FERNANDO,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
PRECISION DYNAMICS CORP.
SAN FERNANDO,  CA ,  US.
PRECISION EAR MOLD LABORATORIES
ALTAMONTE SPRINGS,  FL,  US.
Initial Importer;   Manufacturer;  
PRECISION LABORATORIES, INC.
ALTAMONTE SPRINGS,  FL ,  US.
PRECISION EDGE SURGICAL PRODUCTS COMPANY LLC
SAULT STE. MARIE,  MI,  US.
Contract Manufacturer;  
COLSON ASSOCIATES, INC.
CHICAGO,  IL ,  US.
PRECISION ELECTROLYSIS NEEDLES, INC.
BARRINGTON,  RI,  US.
Manufacturer;  
PRECISION ELECTROLYSIS NEEDLES, INC.
BARRINGTON,  RI ,  US.
PRECISION ENDOSCOPY OF AMERICA, INC.
HUNT VALLEY,  MD,  US.
Initial Importer;  
PRECISION ENDOSCOPY OF AMERICA, INC.
HUNT VALLEY,  MD ,  US.
PRECISION ENGINEERED PRODUCTS INC.
TAIPEI,  TW.
Manufacturer;  
PRECISION ENGINEERED PRODUCTS INC.
TAIPEI,  TW.
PRECISION EYEWEAR, INC.
DEAL,  NJ,  US.
Initial Importer;  
PRECISION EYEWEAR, INC.
DEAL,  NJ ,  US.
PRECISION FABRICS GROUP, INC.
GREENSBORO,  NC,  US.
Manufacturer;  
PRECISION FABRICS GROUP, INC.
GREENSBORO,  NC ,  US.

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Last Modified: 29 April 2006
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