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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
BACKLIFE, LTD.
TEL AVIV,  IS.
Manufacturer;  
BACKLIFE, LTD.
TEL AVIV,  IS.
BACK-MUELLER, INC.
ST. LOUIS,  MO,  US.
Manufacturer;  
BACK-MUELLER, INC. SURGICAL INSTR.
ST. LOUIS,  MO ,  US.
BACKPROJECT CORPORATION
SUNNYVALE,  CA,  US.
Specification Developer;  
BACKPROJECT CORPORATION
SUNNYVALE,  CA ,  US.
BACKSTRONG INTERNATIONAL LLC.
BREA,  CA,  US.
Manufacturer;  
BACKSTRONG INTL.
BREA,  CA ,  US.
BACTERIN INTERNATIONAL INC.
BELGRADE,  MT,  US.
Contract Manufacturer;   Manufacturer;  
BACTERIN INTERNATIONAL INC.
BELGRADE,  MT ,  US.
BACTI-LAB, INC.
MOUNTAIN VIEW,  CA,  US.
Manufacturer;  
BACTI-LAB, INC.
MOUNTAIN VIEW,  CA ,  US.
BACTON ASSAY SYSTEMS, INC.
SAN MARCOS,  CA,  US.
Contract Manufacturer;   Manufacturer;  
BACTON ASSAY SYSTEMS, INC.
SAN MARCOS,  CA ,  US.
BACTUS AB
HUDDINGE,  SW.
Manufacturer;  
BACTUS AB
HUDDINGE,  SW.
BAD ISCHLER EDELSTAHL-KONSTRUKTIONS-UND-LEICHTMETA
BAD ISCHL,  AU.
Contract Manufacturer;  
BAD ISCHLER EDELSTAHL-KONSTRUKTIONS-UND-LEICHTMETA
BAD ISCHL,  AU.
BADA U.S.A., INC.
LOS ANGELES,  CA,  US.
Initial Importer;  
BADA U.S.A., INC.
LOS ANGELES,  CA ,  US.
BAG ENTERPRISES, INC.
MIAMI,  FL,  US.
Specification Developer;  
BAG ENTERPRISES, INC.
MIAMI,  FL ,  US.
BAGBLOCKER, INC
GREENWOOD,  IN,  US.
Manufacturer;  
BAGBLOCKER, INC
GREENWOOD,  IN ,  US.
BAGRAD
MIDDLEBURG,  FL,  US.
Manufacturer;  
BAGRAD
MIDDLEBURG,  FL ,  US.
BAHAMONDE EYE INSTRUMENTS, INC.
MIAMI,  FL,  US.
Initial Importer;  
BAHAMONDE EYE INSTRUMENTS, INC.
MIAMI,  FL ,  US.
BAI QING TEXTILE MANUFACTURY CO., LTD.
ANQING, ANHUI,  CH.
Unregistered Foreign Lister;  
BAI QING TEXTILE MANUFACTURY CO., LTD.
ANQING, ANHUI,  CH.
BAIGSONS INTL.
RAWALPINI,  PK.
Unregistered Foreign Lister;  
BAIGSONS INTL.
RAWALPINI,  PK.
BAILEY INSTRUMENTS LTD.
MANCHESTER,  UK.
Manufacturer;  
BAILEY INSTRUMENTS LTD.
MANCHESTER,  UK.
BAILEY MEDICAL ENGINEERING
LOS OSOS,  CA,  US.
Initial Importer;   Manufacturer;  
BAILEY MEDICAL ENGINEERING
LOS OSOS,  CA ,  US.
BAILEY MFG. CO.
LODI,  OH,  US.
Manufacturer;  
BAILEY MFG. CO.
LODI,  OH ,  US.
BAIMAI HOT & COLD PACKS INDUSTRIES, INC
SHANGHAI,  CH.
Manufacturer;   Specification Developer;  
BAIMAI HOT & COLD PACKS INDUSTRIES, INC
SHANGHAI,  CH.
BAIRD INDUSTRIES
HOHOKUS,  NJ,  US.
Contract Manufacturer;  
BAIRD INDUSTRIES
HOHOKUS,  NJ ,  US.
BAIWA, INC.
ZEPHYR COVE,  NV,  US.
Manufacturer;  
BAIWA, INC.
STATELINE,  NV ,  US.
BAIYI GROUP CO.
IRVINE,  CA,  US.
Initial Importer;  
BAIYI GROUP CO.
IRVINE,  CA ,  US.
BAJA BIOMEDICAL
TECATE B C,  MX.
Manufacturer;  
BAJA BIOMEDICAL
TECATE B C,  MX.
BAJWA SURGICAL WORKS
SAILKOT, PUNJAB,  PK.
Manufacturer;  
BAJWA SURGICAL WORKS
SAILKOT, PUNJAB,  PK.
BAKER CHIROPRACTIC CLINIC
KANSAS CITY,  KS,  US.
Initial Importer;  
BAKER CHIROPRACTIC CLINIC
KANSAS CITY,  KS ,  US.
BAKER EYE ASSOCIATES, PC
PEABODY,  MA,  US.
Initial Importer;  
BAKER EYE ASSOCIATES, PC
PEABODY,  MA ,  US.
BAKERS SERVICES LTD.
EVERETT,  WA,  US.

BAKERS SERVICES LTD.
EVERETT,  WA ,  US.
BAKTEC, INC.
SARASOTA,  FL,  US.

BAKTEC, INC.
SARASOTA,  FL ,  US.
BALANCE SYSTEMS, INC.
REDMOND,  OR,  US.
Specification Developer;  
BALANCE SYSTEMS, INC.
REDMOND,  OR ,  US.
BALANCETEC CO., LTD.
HWASEONG, GYEONGGI-DO,  KS.
Manufacturer;  
BALANCETEC CO., LTD.
HWASEONG, GYEONGGI-DO,  KS.
BALBOA MANUFACTURING CO., LLC
POWAY,  CA,  US.
Initial Importer;  
BALBOA MANUFACTURING CO., LLC
POWAY,  CA ,  US.
BALCO INDUSTRIES, INC.
GARDEN CITY,  NY,  US.
Initial Importer;  
BALCO INDUSTRIES, INC.
GARDEN CITY,  NY ,  US.
BALEGO AND ASSOC., INC.
NEW BRIGHTON,  MN,  US.

BALEGO AND ASSOC., INC.
NEW BRIGHTON,  MN ,  US.
BALESTER OPTICAL CO., INC.
WILKES-BARRE,  PA,  US.
Initial Importer;  
BALESTER OPTICAL CO., INC.
WILKES-BARRE,  PA ,  US.
BALL DYNAMICS INTL., INC.
LONGMONT,  CO,  US.
Initial Importer;  
BALL DYNAMICS INTL., INC.
LONGMONT,  CO ,  US.
BALLARD MEDICAL PRODUCTS
DRAPER,  UT,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
KIMBERLY-CLARK CORP.
IRVING,  TX ,  US.
BALLARD MEDICAL PRODUCTS
POCATELLO,  ID,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KIMBERLY-CLARK CORP.
IRVING,  TX ,  US.
BALLARD OPTICAL, P.S.
SEATTLE,  WA,  US.
Initial Importer;  
BALLARD OPTICAL, P.S.
SEATTLE,  WA ,  US.
BALLET TECHNOLOGIES LTD.
BIGGLESWADE, BEDFORDSHIRE,  UK.
Foreign Exporter;  
BALLET TECHNOLOGIES LTD.
BIGGLESWADE, BEDFORDSHIRE,  UK.

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Last Modified: 29 April 2006
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