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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
AMERICAN CONTRACT SYSTEMS
AUBURN,  WA,  US.
Contract Sterilizer;   Repackager/Relabeller;  
AMERICAN CONTRACT SYSTEMS
BLOOMINGTON,  MN ,  US.
AMERICAN CONTRACT SYSTEMS
KANSAS CITY,  MO,  US.
Contract Sterilizer;   Repackager/Relabeller;  
AMERICAN CONTRACT SYSTEMS
BLOOMINGTON,  MN ,  US.
AMERICAN CONTRACT SYSTEMS
TAMPA,  FL,  US.
Contract Sterilizer;   Repackager/Relabeller;  
AMERICAN CONTRACT SYSTEMS
BLOOMINGTON,  MN ,  US.
AMERICAN CONTRACT SYSTEMS
WAUNAKEE,  WI,  US.
Contract Sterilizer;   Repackager/Relabeller;  
AMERICAN CONTRACT SYSTEMS
BLOOMINGTON,  MN ,  US.
AMERICAN COPAK CORP.
CHATSWORTH,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMERICAN COPAK CORP.
CHATSWORTH,  CA ,  US.
AMERICAN CROWN INC.
MOBILE,  AL,  US.
Initial Importer;  
AMERICAN CROWN INC.
MOBILE,  AL ,  US.
AMERICAN DAWN, INC.
COMPTON,  CA,  US.
Initial Importer;  
AMERICAN DAWN, INC.
COMPTON,  CA ,  US.
AMERICAN DENTAL ACCESSORIES, INC.
ST. LOUIS PARK,  MN,  US.
Initial Importer;   Repackager/Relabeller;  
AMERICAN DENTAL ACCESSORIES, INC.
ST. LOUIS PARK,  MN ,  US.
AMERICAN DENTAL CENTER OF PROVO
PROVO,  UT,  US.
Initial Importer;   Manufacturer;  
AMERICAN DENTAL CENTER OF PROVO
PROVO,  UT ,  US.
AMERICAN DENTAL CENTERS, L.L.C.
LOS ANGELES,  CA,  US.
Initial Importer;  
AMERICAN DENTAL CENTERS, L.L.C.
LOS ANGELES,  CA ,  US.
AMERICAN DENTAL DESIGNS INC.
NORTH WALES,  PA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMERICAN DENTAL DESIGNS INC.
NORTH WALES,  PA ,  US.
AMERICAN DENTAL IMPLANT CORPORATION
NEW CASTLE,  PA,  US.
Specification Developer;  
AMERICAN DENTAL IMPLANT CORPORATION
NEW CASTLE,  PA ,  US.
AMERICAN DENTAL PRODUCTS, INC.
BENSENVILLE,  IL,  US.
Manufacturer;  
AMERICAN DENTAL PRODUCTS, INC.
BENSENVILLE,  IL ,  US.
AMERICAN DENTAL PRODUCTS, INC.
FLORAL PARK,  NY,  US.
Initial Importer;  
AMERICAN DENTAL PRODUCTS, INC.
FLORAL PARK,  NY ,  US.
AMERICAN DENT-ALL, INC.
GLENDALE,  CA,  US.
Manufacturer;  
AMERICAN DENT-ALL, INC.
GLENDALE,  CA ,  US.
AMERICAN DIAGNOSTIC CORP.
HAUPPAUGE,  NY,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
AMERICAN DIAGNOSTIC CORP.
HAUPPAUGE,  NY ,  US.
AMERICAN DIAGNOSTICA, INC.
STAMFORD,  CT,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMERICAN DIAGNOSTICA, INC.
STAMFORD,  CT ,  US.
AMERICAN DIAMOND INSTRUMENTS
BLAIRSDEN,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
AMERICAN DIAMOND INSTRUMENTS
BLAIRSDEN,  CA ,  US.
AMERICAN DISPOSABLES, INC.
WARE,  MA,  US.
Manufacturer;  
AMERICAN DISPOSABLES, INC.
WARE,  MA ,  US.
AMERICAN EAGLE INSTRUMENTS, INC.
MISSOULA,  MT,  US.
Manufacturer;  
AMERICAN EAGLE INSTRUMENTS, INC.
MISSOULA,  MT ,  US.
AMERICAN ELECTRONIC ASSEMBLY, INC.
BOYNTON BEACH,  FL,  US.
Contract Manufacturer;  
AMERICAN ELECTRONIC ASSEMBLY, INC.
BOYNTON BEACH,  FL ,  US.
AMERICAN ENTERPRISES
CARSON CITY,  NV,  US.
Initial Importer;   Repackager/Relabeller;  
THE URUGUAIAN CROWN CORP. S.A.
BUENOS AIRES,  AR.
AMERICAN EYEWEAR, INC.
DALLAS,  TX,  US.
Initial Importer;  
AMERICAN EYEWEAR, INC.
DALLAS,  TX ,  US.
AMERICAN FIBER & FINISHING, INC.
ALBEMARLE,  NC,  US.
Contract Manufacturer;   Manufacturer;  
AMERICAN FIBER & FINISHING, INC.
ALBEMARLE,  NC ,  US.
AMERICAN FIRST AID CO.
HANOVER,  MD,  US.
Initial Importer;   Repackager/Relabeller;  
AMERICAN FIRST AID CO.
HANOVER,  MD ,  US.
AMERICAN FUN AND TOY CREATORS, INC.
SALT POINT,  NY,  US.
Initial Importer;  
AMERICAN FUN AND TOY CREATORS, INC.
SALT POINT,  NY ,  US.
AMERICAN FUNDING GROUP, INC.
ROCHESTER,  MI,  US.
Initial Importer;  
AMERICAN FUNDING GROUP, INC.
ROCHESTER,  MI ,  US.
AMERICAN GAGE & MEDICAL, INC.
SAN FRANCISCO,  CA,  US.
Initial Importer;  
AMERICAN GAGE & MEDICAL, INC.
SAN FRANCISCO,  CA ,  US.
AMERICAN GIRL, INC.
MIDDLETON,  WI,  US.
Specification Developer;   Repackager/Relabeller;  
AMERICAN GIRL, INC.
MIDDLETON,  WI ,  US.
AMERICAN GLOVES INC.
PALM DESERT,  CA,  US.
Initial Importer;  
AMERICAN GLOVES INC.
PALM DESERT,  CA ,  US.
AMERICAN HAIR REMOVAL SYSTEM, INC.
SOUTHERN PINES,  NC,  US.
Manufacturer;  
AMERICAN HAIR REMOVAL SYSTEM, INC.
SOUTHERN PINES,  NC ,  US.
AMERICAN HAND PROSTHETICS, INC.
BROOKLYN,  NY,  US.
Manufacturer;  
AMERICAN HAND PROSTHETICS, INC.
NEW YORK,  NY ,  US.
AMERICAN HEALTH & SAFETY, INC.
MADISON,  WI,  US.
Initial Importer;  
AMERICAN HEALTH & SAFETY, INC.
MADISON,  WI ,  US.
AMERICAN HEALTH AND BEAUTY CARE INC.
E. FREETOWN,  MA,  US.
Initial Importer;  
AMERICAN HEALTH AND BEAUTY CARE INC.
E. FREETOWN,  MA ,  US.
AMERICAN HEALTH CARE SYSTEMS, INC.
METAIRIE,  LA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
AMERICAN HEALTH CARE SYSTEMS, INC.
METAIRIE,  LA ,  US.
AMERICAN HEALTH PRODUCTS CORP.
GLENDALE HTS.,  IL,  US.
Initial Importer;  
AMERICAN HEALTH PRODUCTS CORP.
GLENDALE HTS.,  IL ,  US.
AMERICAN HEALTH SERVICE SALES CORP.
METTAWA,  IL,  US.
Initial Importer;  
AMERICAN HEALTH SERVICE SALES CORP.
METTAWA,  IL ,  US.
AMERICAN HEALTH SYSTEMS, INC.
GREENVILLE,  SC,  US.
Specification Developer;  
AMERICAN HEALTH SYSTEMS, INC.
GREENVILLE,  SC ,  US.
AMERICAN HEALTHCARE
SCARBOROUGH,  ME,  US.
Manufacturer;  
AMERICAN HEALTHCARE
SCARBOROUGH,  ME ,  US.
AMERICAN HEALTHCARE (CHINA), LTD.
NANJING,  CH.
Manufacturer;  
AMERICAN HEALTHCARE GROUP, INC.
WILMINGTON,  NC ,  US.

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Last Modified: 29 April 2006
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