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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
ABBOTT IRELAND VASCULAR DIVISION
GALWAY,  EI.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT JAPAN CO., LTD
MATSUDO CITY, CHIBA,  JA.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
ABBOTT PARK,  IL,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
COLUMBUS,  OH,  US.
Specification Developer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
COLUMBUS,  OH,  US.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
COLUMBUS,  OH,  US.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
IRVING,  TX,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
NORTH CHICAGO,  IL,  US.
Contract Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
NORTH CHICAGO,  IL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
SANTA CLARA,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES
SOUTH PASADENA,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES (PUERTO RICO), INC.
CAROLINA,  PR,  US.
Initial Importer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT LABORATORIES VASCULAR ENTERPRISES, LTD., DU
BERINGEN,  SZ.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT MOLECULAR, INC.
DES PLAINES,  IL,  US.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT RESEARCH GROUP, INC.
PITTSBURGH,  PA,  US.
Specification Developer;  
ABBOTT RESEARCH GROUP, INC.
PITTSBURGH,  PA ,  US.
ABBOTT SMITH LABS, LLC
WESTON,  FL,  US.
Manufacturer;   Specification Developer;  
ABBOTT SMITH LABS, LLC
WESTON,  FL ,  US.
ABBOTT SPINE, INC.
BORDEAUX,  FR.
Manufacturer;   Specification Developer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT SPINE, INC.
AUSTIN,  TX,  US.
Initial Importer;   Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT VASCULAR INC.
REDWOOD CITY,  CA,  US.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND GMBH
RANGENDINGEN,  GM.
Manufacturer;  
ABBOTT LABORATORIES
ABBOTT PARK,  IL ,  US.
ABBS VISION SYSTEMS
VENTURA,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
ABBS VISION SYSTEMS
VENTURA,  CA ,  US.
ABC DISTRIBUTING, LLC
NORTH MIAMI,  FL,  US.
Initial Importer;  
ABC DISTRIBUTING, LLC
NORTH MIAMI,  FL ,  US.
ABC HEALTH SOLUTIONS LLC
KENT,  WA,  US.
Manufacturer;  
ABC HEALTH SOLUTIONS LLC
KENT,  WA ,  US.
ABC OPTICAL MANUFACTURERS & TRADERS LTD.
KOWLOON, TST,  HK.
Unregistered Foreign Lister;  
ABC OPTICAL MANUFACTURERS & TRADERS LTD.
KOWLOON, TST,  HK.
ABC SHEET METAL
ANAHEIM,  CA,  US.
Contract Manufacturer;  
STEELDYN INDUSTRIES
ANAHEIM,  CA ,  US.
ABC VISION CENTER
LOS ANGELES,  CA,  US.
Initial Importer;  
ABC VISION CENTER
LOS ANGELES,  CA ,  US.
ABCZRURAL
MOORESTOWN,  NJ,  US.
Initial Importer;  
ABCZRURAL
MOORESTOWN,  NJ ,  US.
ABDUL REHMAN & SONS
LAHORE,  PK.
Foreign Exporter;   Manufacturer;  
ABDUL REHMAN & SONS
LAHORE,  PK.
ABE SYSTEMS
SANTA CRUZ,  CA,  US.
Manufacturer;  
ABE SYSTEMS
SANTA CRUZ,  CA ,  US.
ABEAMED, INC.
CORAL GABLES,  FL,  US.
Initial Importer;  
ABEAMED, INC.
CORAL GABLES,  FL ,  US.
ABEL DENTAL LAB
UNIONTOWN,  PA,  US.
Initial Importer;   Manufacturer;  
SENTAGE CORPORATION
MINNEAPOLIS,  MN ,  US.
ABEL UNLIMITED, INC.
WEST PALM BEACH,  FL,  US.
Initial Importer;  
ABEL UNLIMITED, INC.
WEST PALM BEACH,  FL ,  US.
ABENA INTERNATIONAL A/S
AABENRAA,  DA.
Manufacturer;  
ABENA INTERNATIONAL A/S
AABENRAA,  DA.
ABERCROMBIE & FITCH
NEW ALBANY,  OH,  US.
Initial Importer;  
ABERCROMBIE & FITCH
NEW ALBANY,  OH ,  US.
ABERDEEN BANDAGE PRODUCTS
HAMILTON, ONTARIO,  CA.
Manufacturer;  
ABERDEEN BANDAGE PRODUCTS
HAMILTON, ONTARIO,  CA.
ABERTEK
SAN FRANCISCO,  CA,  US.
Initial Importer;  
COTRONIC MANUFACTURING
SHEN ZHEN, GUANG DONG PROVINCE,  CH.
ABET MEDICAL
ABINGTON,  PA,  US.

ABET MEDICAL
ABINGTON,  PA ,  US.
ABHI ASSOC.
AURORA,  CO,  US.
Initial Importer;  
ABHI ASSOC.
AURORA,  CO ,  US.
ABI CORP.
GUAYNABO,  PR,  US.
Initial Importer;  
ABI CORP.
GUAYNABO,  PR ,  US.
ABIGO MEDICAL AB
ASKIM,  SW.
Manufacturer;   Specification Developer;  
ABIGO MEDICAL AB
ASKIM,  SW.

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Last Modified: 29 April 2006
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