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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
B&J CO., LTD.
GWANGJU GYEONGGI-DO,  KS.
Manufacturer;  
B&J CO., LTD.
GWANGJU GYEONGGI-DO,  KS.
B&K MEDICAL SYSTEMS, INC.
WILMINGTON,  MA,  US.
Initial Importer;  
B&K MEDICAL SYSTEMS, INC.
WILMINGTON,  MA ,  US.
B&M PRECISION, INC.
RUSKIN,  FL,  US.
Contract Manufacturer;  
B&M PRECISION, INC.
RUSKIN,  FL ,  US.
B. ALI IMPEX
SIALKOT, PUNJAB,  PK.
Manufacturer;  
B. ALI IMPEX
SIALKOT, PUNJAB,  PK.
B. BRAUN AESCULAP JAPAN CO., LTD.
TOCHIGI,  JA.
Manufacturer;  
B. BRAUN MELSUNGEN AG
MELSUNGEN,  GM.
B. BRAUN CAREX SPA
MIRANDOLA,  IT.
Manufacturer;   Specification Developer;  
B. BRAUN MEDIZINTECHNOLOGIE GMBH
MELSUNGEN,  GM.
B. BRAUN HOSPICARE
COUNTY SLIGO,  EI.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
B. BRAUN MELSUNGEN AG
MELSUNGEN,  GM.
B. BRAUN MEDICAL AG
ESCHOLZMATT,  SZ.
Manufacturer;  
B. BRAUN MELSUNGEN AG
MELSUNGEN,  GM.
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
PENANG,  MY.
Manufacturer;  
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
PENANG,  MY.
B. BRAUN MEDICAL LTD
GYONGYOS, DELI-KUIHATAR UT 2-4,  HU.
Manufacturer;  
B. BRAUN MELSUNGEN AG
MELSUNGEN,  GM.
B. BRAUN MEDICAL LTD
SHEFFIELD, SOUTH YORKSHIRE,  UK.
Manufacturer;  
B/BRAUN MEDICAL LTD.
SHEFFIELD, SOUTH YORKSHIRE,  UK.
B. BRAUN MEDICAL SAS
CHASSENEUIL, CEDEX,  FR.
Manufacturer;  
B. BRAUN MEDICAL SAS
BILLANCOURT,  FR.
B. BRAUN MEDICAL SAS
SAINT-JEAN-DE-LUZ, CEDEX,  FR.
Manufacturer;  
B. BRAUN MEDICAL SAS
BILLANCOURT,  FR.
B. BRAUN MEDICAL, INC.
ALLENTOWN,  PA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Contract Sterilizer;   Repackager/Relabeller;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA,  US.
Initial Importer;   Repackager/Relabeller;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. BRAUN MEDICAL, INC.
BREINIGSVILLE,  PA,  US.
Initial Importer;   Repackager/Relabeller;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. BRAUN MEDICAL, INC.
CARROLLTON,  TX,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. BRAUN MEDICAL, INC.
CHERRY HILL,  NJ,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. BRAUN MEDICAL, INC.
IRVINE,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. BRAUN MEDICAL, S.A.
RUBI,  SP.
Contract Manufacturer;   Manufacturer;   Contract Sterilizer;  
B. BRAUN MELSUNGEN AG
MELSUNGEN,  GM.
B. BRAUN MEDIZIN ELEKTRONIK GMBH & CO
PUCHHEIM,  GM.
Manufacturer;  
B. BRAUN MEDIZIN ELEKTRONIK GMBH & CO
PUCHHEIM,  GM.
B. BRAUN MEDIZINTECHNOLOGIE GMBH
GLANDORF,  GM.
Contract Manufacturer;   Manufacturer;   Contract Sterilizer;  
B. BRAUN MEDIZINTECHNOLOGIE GMBH
MELSUNGEN,  GM.
B. BRAUN MEDIZINTECHNOLOGIE GMBH
MELSUNGEN,  GM.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
B. BRAUN MEDIZINTECHNOLOGIE GMBH
MELSUNGEN,  GM.
B. BRAUN MELSUNGEN AG
MELSUNGEN,  GM.
Manufacturer;   Specification Developer;  
B. BRAUN MELSUNGEN AG
MELSUNGEN,  GM.
B. BRAUN OF DOMINICAN REPUBLIC
PARQUE LAS AMERICAS,  DR.
Contract Manufacturer;   Manufacturer;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. BRAUN OF PUERTO RICO, INC.
SABANA GRANDE,  PR,  US.
Contract Manufacturer;   Manufacturer;  
B. BRAUN MEDICAL, INC.
BETHLEHEM,  PA ,  US.
B. GRACZYK, INC.
SCOTTSDALE,  AZ,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
B. GRACZYK, INC.
SCOTTSDALE,  AZ ,  US.
B. ROBINSON OPTICAL, INC.
NEW YORK,  NY,  US.
Initial Importer;  
B. ROBINSON OPTICAL, INC.
NEW YORK,  NY ,  US.
B. VICTOR CRANE & CO.
SIALKOT,  PK.
Manufacturer;  
B. VICTOR CRANE & CO.
SIALKOT,  PK.
B. WEBBER & CO.
LAHORE,  PK.
Manufacturer;  
B. WEBBER & CO.
LAHORE,  PK.
B.A.S.
LINWOOD,  NJ,  US.
Initial Importer;  
B.A.S.
LINWOOD,  NJ ,  US.
B.B.'S PROPHY SHOP
GREVENBROICH,  GM.
Foreign Exporter;  
B.B.'S PROPHY SHOP
GREVENBROICH,  GM.
B.B.S. INTERNATIONAL
SIALKOT, PB,  PK.
Manufacturer;  
B.B.S. INTERNATIONAL
SIALKOT, PB,  PK.
B.C.B. INTL., LTD.
CARDIFF,  UK.
Unregistered Foreign Lister;  
B.C.B. INTL., LTD.
CARDIFF,  UK.
B.D. KOREA CO., LTD.
SEOUL,  KS.
Manufacturer;  
B.D. KOREA CO., LTD.
SEOUL,  KS.
B.E.C. MFG. CORP.
SADDLE BROOK,  NJ,  US.
Contract Manufacturer;  
B.E.C. MFG. CORP.
SADDLE BROOK,  NJ ,  US.
B.G. SULZLE, INC.
NORTH SYRACUSE,  NY,  US.
Contract Manufacturer;  
B.G. SULZLE, INC.
NORTH SYRACUSE,  NY ,  US.
B.G.H. BIOCHEMICAL CO.
TAIPEI,  TW.
Manufacturer;  
B.G.H. BIOCHEMICAL CO.
TAIPEI,  TW.
B.G.T. INTL., S.A.
CABRERA DE MAR, BARCELONA,  SP.
Unregistered Foreign Lister;  
B.G.T. INTL., S.A.
CABRERA DE MAR, BARCELONA,  SP.
B.H. MEDICAL PRODUCTS CO., LTD.
CHANGZHOU, JIANGSU,  CH.
Manufacturer;  
B.H. MEDICAL PRODUCTS CO., LTD.
CHANGZHOU, JIANGSU,  CH.

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Last Modified: 29 April 2006
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