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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
BRAY HEALTH AND LEISURE LTD.
ALCESTER,  UK.
Manufacturer;  
BRAY HEALTH AND LEISURE LTD.
ALCESTER,  UK.
BRC OPERATIONS PTY LIMITED
SYDNEY NSW,  AS.
Manufacturer;  
BRC OPERATIONS PTY LIMITED
SYDNEY NSW,  AS.
BRDR. LUDVIGSEN APS
TOMMERUP,  DA.
Manufacturer;  
BRDR. LUDVIGSEN APS
TOMMERUP,  DA.
BREAKAWAY IMAGING, LLC
LITTLETON,  MA,  US.
Manufacturer;   Specification Developer;  
BREAKAWAY IMAGING, LLC
LITTLETON,  MA ,  US.
BREAS MEDICAL AB
MOLNLYCKE,  SW.
Manufacturer;   Remanufacturer;  
BREAS MEDICAL AB
MOLNLYCKE,  SW.
BREASY MEDICAL EQUIPMENT LTD.
LONDON,  UK.
Manufacturer;  
BREASY MEDICAL EQUIPMENT LTD.
LONDON,  UK.
BREATH FREE LEE, INC.
SLC-SALT LAKE CITY,  UT,  US.
Manufacturer;  
BREATH FREE LEE, INC.
SLC-SALT LAKE CITY,  UT ,  US.
BREATHAID, LLC.
CAMDEN,  SC,  US.
Specification Developer;  
BREATHAID, LLC.
CAMDEN,  SC ,  US.
BREATHE E-Z SYSTEMS, INC.
LEAWOOD,  KS,  US.
Manufacturer;  
BREATHE E-Z SYSTEMS, INC.
LEAWOOD,  KS ,  US.
BREATHE WITH EEZ CORP.
BROOKLYN,  NY,  US.
Manufacturer;  
BREATHE WITH EEZ CORP.
BROOKLYN,  NY ,  US.
BREATHE-ENFORCER CO.
ROCHESTER,  MN,  US.
Manufacturer;  
BREATHE-ENFORCER CO.
ROCHESTER,  MN ,  US.
BREAUX DENTAL PROSTHETICS
BEAUMONT,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
BREAUX DENTAL PROSTHETICS
BEAUMONT,  TX ,  US.
BRECONRIDGE MANUFACTURING SOLUTIONS
OTTAWA, ONTARIO,  CA.
Contract Manufacturer;  
BRECONRIDGE MANUFACTURING SOLUTIONS
OTTAWA, ONTARIO,  CA.
BRECONRIDGE MANUFACTURING SOLUTIONS
OGDENSBURG,  NY,  US.
Contract Manufacturer;  
BRECONRIDGE MANUFACTURING SOLUTIONS
OGDENSBURG,  NY ,  US.
BRECONRIDGE MANUFACTURING SOLUTIONS
OGDENSBURG,  NY,  US.
Contract Manufacturer;  
BRECONRIDGE MANUFACTURING SOLUTIONS
OGDENSBURG,  NY ,  US.
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
SENDEN, BAYERN,  GM.
Manufacturer;  
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
SENDEN, BAYERN,  GM.
BREEN LABS
ADELANTO,  CA,  US.
Manufacturer;  
BREEN LABS
ADELANTO,  CA ,  US.
BREEZE HEALTHCARE PRODUCT, INC.
CARLSBAD,  CA,  US.
Initial Importer;  
BREEZE HEALTHCARE PRODUCT, INC.
CARLSBAD,  CA ,  US.
BREG MEXICO S.A. DE RL DE C.V.
MEXICALI, BAJA CALIFORNIA,  MX.
Manufacturer;  
BREG, INC.
VISTA,  CA ,  US.
BREG, INC., AN ORTHOFIX COMPANY
VISTA,  CA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ORTHOFIX INTERNATIONAL NV
CURACAO,  NT.
BREGAS AB
BROMMA,  SW.
Manufacturer;  
BREGAS AB
BROMMA,  SW.
BREGMA INTERNATIONAL TRADING COMPANY LTD.
SASKATOON, SASKATCHEWAN,  CA.
Manufacturer;  
BREGMA INTERNATIONAL TRADING COMPANY LTD.
SASKATOON, SASKATCHEWAN,  CA.
BREMED ITALIA, S.R.L.
GORIZIA,  IT.
Contract Manufacturer;   Manufacturer;  
BREMED ITALIA, S.R.L.
GORIZIA,  IT.
BREMEN CORP.
BREMEN,  IN,  US.
Manufacturer;  
BREMEN CORP.
BREMEN,  IN ,  US.
BRENDEL LUNETTES
FUERTH,  GM.
Unregistered Foreign Lister;  
BRENDEL LUNETTES
FUERTH,  GM.
BRENNAN LAKE CORPORATION
GEORGETOWN, ONTARIO,  CA.
Specification Developer;  
BRENNAN LAKE CORPORATION
GEORGETOWN, ONTARIO,  CA.
BRENNEN MEDICAL, LLC
ST. PAUL,  MN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
BRENNEN MEDICAL, LLC
ST. PAUL,  MN ,  US.
BRENNER METAL PROD CORP.
WALLINGTON,  NJ,  US.
Contract Manufacturer;   Manufacturer;  
BRENNER METAL PROD CORP.
WALLINGTON,  NJ ,  US.
BRENNER TOOL & DIE, INC.
CROYDON,  PA,  US.
Contract Manufacturer;  
BRENNER TOOL & DIE, INC.
CROYDON,  PA ,  US.
BRENTFORTON ACADEMY AND CLINIC
BRETFORTON, WORCESTERSHIRE,  UK.
Manufacturer;  
DR.SIR.PETER GUY MANNERS
BRETFORTON,  UK.
BRENTWOOD MEDICAL TECHNOLOGY CORP.
TORRANCE,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
BRENTWOOD MEDICAL TECHNOLOGY CORP.
TORRANCE,  CA ,  US.
BREONICS, INC.
OTISVILLE,  NY,  US.
Contract Manufacturer;   Manufacturer;  
BREONICS INC
OTISVILLE,  NY ,  US.
BRETHERTON THERAPY PRODUCTS
BEESTON SANDY, BEDFORDSHIRE,  UK.
Unregistered Foreign Lister;  
BRETHERTON THERAPY PRODUCTS
BEESTON SANDY, BEDFORDSHIRE,  UK.
BRETHREN CORP.
TOKYO,  JA.
Repackager/Relabeller;  
BRETHREN CORP.
TOKYO,  JA.
BRETTON SQUARE INDUSTRIES
LANSING,  MI,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
COMMUNITY SERVICES FOR DEVELOPMENTALLY DISABLED
LANSING,  MI ,  US.
BREVET, INC.
IRVINE,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
BREVET, INC.
IRVINE,  CA ,  US.
BRICK MEDICAL, LLC
MCKINNEY,  TX,  US.
Initial Importer;  
BRICK MEDICAL, LLC
MCKINNEY,  TX ,  US.
BRICO S.R.L.
DORMELLETTO,  IT.
Unregistered Foreign Lister;  
BRICO S.R.L.
DORMELLETTO,  IT.
BRIDENT INC.
ARCADIA,  CA,  US.
Reprocessor of single-use devices;   Repackager/Relabeller;  
BRIDENT INC.
ARCADIA,  CA ,  US.
BRIDGER BIOMED, INC.
BOZEMAN,  MT,  US.
Contract Manufacturer;   Manufacturer;  
C.R. BARD, INC.
MURRAY HILL,  NJ ,  US.

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Last Modified: 29 April 2006
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