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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 PRODUCT DISTRIBUTIONS, INC.
COLUMBUS,  OH,  US.
Repackager/Relabeller;  
AMERICAN PRODUCT DISTRIBUTIONS, INC.
COLUMBUS,  OH ,  US.
AMERICAN PRODUCTS, LLC.
STRAFFORD,  MO,  US.
Contract Manufacturer;  
AMERICAN PRODUCTS, LLC.
STRAFFORD,  MO ,  US.
AMERICAN PROFESSIONAL BRACING, INC.
EATONTOWN,  NJ,  US.
Initial Importer;  
FLA. ORTHOPEDICS, INC.
MIRAMAR,  FL ,  US.
AMERICAN QUALEX, INC.
SAN CLEMENTE,  CA,  US.
Contract Manufacturer;  
AMERICAN QUALEX, INC.
SAN CLEMENTE,  CA ,  US.
AMERICAN QUALITY MFG., INC.
COCOA,  FL,  US.
Manufacturer;  
AMERICAN QUALITY MFG., INC.
COCOA,  FL ,  US.
AMERICAN RADIOSURGERY, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;  
AMERICAN RADIOSURGERY, INC.
SAN DIEGO,  CA ,  US.
AMERICAN RAG CIE
SAN FRANCISCO,  CA,  US.
Initial Importer;  
MARK WERTS
LOS ANGELES,  CA ,  US.
AMERICAN RAG LLC
LOS ANGELES,  CA,  US.
Initial Importer;  
AMERICAN RAG LLC
LOS ANGELES,  CA ,  US.
AMERICAN RED CROSS DIAGNOSTIC MANUFACTURING DIVISI
GAITHERSBURG,  MD,  US.
Initial Importer;   Manufacturer;  
AMERICAN NATIONAL RED CROSS HEADQUARTERS
WASHINGTON,  DC ,  US.
AMERICAN RELIABLE PRODUCTS, INC.
SAN GABRIEL,  CA,  US.
Initial Importer;  
AMERICAN RELIABLE PRODUCTS, INC.
SAN GABRIEL,  CA ,  US.
AMERICAN SAFETY & FIRST AID
OSCEOLA,  IN,  US.
Initial Importer;   Repackager/Relabeller;  
AMERICAN SAFETY & FIRST AID
OSCEOLA,  IN ,  US.
AMERICAN SAFETY RAZOR CO.
VERONA,  VA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
AMERICAN SAFETY RAZOR CO.
VERONA,  VA ,  US.
AMERICAN SAFTIGARD, INC.
GLENDALE,  AZ,  US.
Initial Importer;  
AMERICAN SAFTIGARD, INC.
GLENDALE,  AZ ,  US.
AMERICAN SCIENCE AND ENGINEERING, INC.
BILLERICA,  MA,  US.
Manufacturer;  
AMERICAN SCIENCE AND ENGINEERING, INC.
BILLERICA,  MA ,  US.
AMERICAN SCIENTIFIC RESOURCES, INC.
NEW PALTZ,  NY,  US.
Initial Importer;   Repackager/Relabeller;  
AMERICAN SCIENTIFIC RESOURCES, INC.
NEW PALTZ,  NY ,  US.
AMERICAN SEAL CO.
HAYWARD,  CA,  US.
Initial Importer;  
AMERICAN SEAL CO.
HAYWARD,  CA ,  US.
AMERICAN SIGNATURE INC.
COLUMBUS,  OH,  US.
Initial Importer;  
AMERICAN SIGNATURE INC.
COLUMBUS,  OH ,  US.
AMERICAN SILK SUTURES, INC.
LYNN,  MA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
AMERICAN SILK SUTURES, INC.
LYNN,  MA ,  US.
AMERICAN SKY DENTAL LAB CO., LTD.
ZHUHAI, GUANGDONG P.R.,  CH.
Contract Manufacturer;  
AMERICAN INTERNATIONAL DENTAL LAB
GAINESVILLE,  GA ,  US.
AMERICAN SPINE CENTER, LTD.
BELLEVILLE,  IL,  US.
Initial Importer;   Repackager/Relabeller;  
AMERICAN SPINE CENTER, LTD.
BELLEVILLE,  IL ,  US.
AMERICAN SPRAYTECH, L.L.C.
NORTH BRANCH,  NJ,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
AMERICAN SPRAYTECH, L.L.C.
NORTH BRANCH,  NJ ,  US.
AMERICAN STANDARD IMPORT/EXPORT, INC.
DARIEN,  IL,  US.
Initial Importer;  
AMERICAN STANDARD IMPORT/EXPORT, INC.
DARIEN,  IL ,  US.
AMERICAN STAR MEDICAL
DUARTE,  CA,  US.
Initial Importer;  
DORNA ENGINEERING CORP.
ARCADIA,  CA ,  US.
AMERICAN SUNBED MANUFACTURERS, INC.
BURR RIDGE,  IL,  US.
Initial Importer;   Specification Developer;  
AMERICAN SUNBED MANUFACTURERS, INC.
BURR RIDGE,  IL ,  US.
AMERICAN SUNSHINE EYEWEAR, INC.
MIAMI,  FL,  US.
Initial Importer;  
AMERICAN SUNSHINE EYEWEAR, INC.
MIAMI,  FL ,  US.
AMERICAN SUPPLY CO., INC.
MINNEAPOLIS,  MN,  US.

AMERICAN SUPPLY CO., INC.
MINNEAPOLIS,  MN ,  US.
AMERICAN SURGICAL DEVICES
FREMONT,  CA,  US.
Initial Importer;   Manufacturer;  
AMERICAN SURGICAL DEVICES
FREMONT,  CA ,  US.
AMERICAN SYRINGE COMPANY
MIAMI,  FL,  US.
Initial Importer;   Specification Developer;  
RETRAX SAFETY SYSTEMS, INC.
MIAMI,  FL ,  US.
AMERICAN TAPE CO.
MARYSVILLE,  MI,  US.
Manufacturer;  
AMERICAN TAPE CO.
MARYSVILLE,  MI ,  US.
AMERICAN TELECARE, INC.
EDEN PRAIRIE,  MN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMERICAN TELECARE, INC.
EDEN PRAIRIE,  MN ,  US.
AMERICAN THERMAL INSTRUMENTS, INC.
DAYTON,  OH,  US.
Manufacturer;  
AMERICAN THERMAL INSTRUMENTS, INC.
DAYTON,  OH ,  US.
AMERICAN TOOTH INDUSTRIES
OXNARD,  CA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
AMERICAN TOOTH INDUSTRIES
OXNARD,  CA ,  US.
AMERICAN TRACK ROADSTERS, INC.
LAKEWOOD,  CO,  US.
Manufacturer;  
AMERICAN TRACK ROADSTERS, INC.
LAKEWOOD,  CO ,  US.
AMERICAN TRADE ALLIANCE, INC.
BOCA RATON,  FL,  US.
Initial Importer;  
AMERICAN TRADE ALLIANCE, INC.
BOCA RATON,  FL ,  US.
AMERICAN TRADING COMPANY
WESTCHESTER,  PA,  US.
Initial Importer;  
AMERICAN TRADING COMPANY
WESTCHESTER,  PA ,  US.
AMERICAN TRANSPORTATION SYSTEMS, LLC
NORFOLK,  VA,  US.
Contract Sterilizer;  
AMERICAN TRANSPORTATION SYSTEMS, LLC
NORFOLK,  VA ,  US.
AMERICAN ULTRAVIOLET CO.
LEBANON,  IN,  US.
Manufacturer;  
AMERICAN ULTRAVIOLET CO.
LEBANON,  IN ,  US.
AMERICAN VERMEIREN CORP.
TOWNSHIP OF WASHINGTON,  NJ,  US.
Initial Importer;  
AMERICAN VERMEIREN CORP.
TOWNSHIP OF WASHINGTON,  NJ ,  US.
AMERICAN VISION WORKS INC.
FRESH MEADOWS,  NY,  US.
Initial Importer;  
AMERICAN VISION WORKS INC.
FRESH MEADOWS,  NY ,  US.
AMERICAN WELLNESS FOUNDATION
HOUSTON,  TX,  US.
Manufacturer;  
AMERICAN WELLNESS FOUNDATION
HOUSTON,  TX ,  US.

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Last Modified: 29 April 2006
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