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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
BETTER BUILT PRODUCTS, LTD.
KINGWOOD,  TX,  US.
Initial Importer;  
BETTER BUILT PRODUCTS, LTD.
KINGWOOD,  TX ,  US.
BETTER CONTAINERS MFG. CO., INC.
HILLSIDE,  IL,  US.
Manufacturer;  
BETTER CONTAINERS MFG. CO., INC.
HILLSIDE,  IL ,  US.
BETTER HANDS GLOVE PRODUCTS
CONCORD,  CA,  US.
Specification Developer;  
BETTER HANDS GLOVE PRODUCTS
CONCORD,  CA ,  US.
BETTER HEALTH SYSTEMS, INC.
MONUMENT,  CO,  US.
Repackager/Relabeller;  
BETTER HEALTH SYSTEMS, INC.
MONUMENT,  CO ,  US.
BETTER HEALTH, INC.
KNOXVILLE,  TN,  US.
Specification Developer;  
BETTER HEALTH, INC.
KNOXVILLE,  TN ,  US.
BETTER HOSPITAL EQUIPMENT CORP.
MIAMI LAKES,  FL,  US.
Initial Importer;  
BETTER HOSPITAL EQUIPMENT CORP.
MIAMI LAKES,  FL ,  US.
BETTER HOSPITAL SUPPLIES CORP.
MIAMI LAKES,  FL,  US.
Initial Importer;  
BETTER HOSPITAL SUPPLIES CORP.
MIAMI LAKES,  FL ,  US.
BETTER LIFE DEVICES
WOODLAND HILLS,  CA,  US.
Initial Importer;  
JOHARI DIGITAL HEALTHCARE, LTD.
JODHPUR,RAJASTHAN,  IN.
BETTER PARTS CO.
MINNEAPOLIS,  MN,  US.
Manufacturer;  
BETTER PARTS CO.
MINNEAPOLIS,  MN ,  US.
BETTER SLEEP MFG. CO.
BERKELEY HEIGHTS,  NJ,  US.
Specification Developer;  
BETTER SLEEP, INC.
BERKELEY HEIGHTS,  NJ ,  US.
BETTER SLEEP, INC.
BERKELEY HTS.,  NJ,  US.
Repackager/Relabeller;  
BETTER SLEEP, INC.
BERKELEY HEIGHTS,  NJ ,  US.
BETTER WATER, INC.
SMYRNA,  TN,  US.
Manufacturer;  
BETTER WATER, INC.
SMYRNA,  TN ,  US.
BETTY CASON LUNETTERIE
SEDICO (BELLUNO),  IT.
Manufacturer;  
BETTY CASON LUNETTERIE
SEDICO (BELLUNO),  IT.
BEURER GMBH & CO.
D89077 ULM,  GM.
Manufacturer;   Remanufacturer;  
BEURER GMBH & CO.
D89077 ULM,  GM.
BEUTLICH LP, PHARMACEUTICALS
WAUKEGAN,  IL,  US.
Specification Developer;   Repackager/Relabeller;  
BEUTLICH LP, PHARMACEUTICALS
WAUKEGAN,  IL ,  US.
BEVERLY ENTERPRISES, INC.
FORT SMITH,  AR,  US.
Initial Importer;  
BEVERLY ENTERPRISES, INC.
FORT SMITH,  AR ,  US.
BEVERLY HILLS TEDDY BEAR COMPANY
SANTA CLARITA,  CA,  US.
Initial Importer;  
BEVERLY HILLS TEDDY BEAR COMPANY
SANTA CLARITA,  CA ,  US.
BEXLEY TRADING, INC.
SAN RAFAEL,  CA,  US.
Initial Importer;   Specification Developer;  
BEXLEY TRADING, INC.
SAN RAFAEL,  CA ,  US.
BEXTMOLD INDUSTRIAL CORP.
TAIPEI,  TW.
Manufacturer;  
BEXTMOLD INDUSTRIAL CORP.
TAIPEI,  TW.
BEY-BERK INTL.
CHATSWORTH,  CA,  US.
Initial Importer;  
BEY-BERK INTL.
CHATSWORTH,  CA ,  US.
BEYOND 21ST CENTURY, INC.
LENEXA,  KS,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
BEYOND 21ST CENTURY, INC.
LENEXA,  KS ,  US.
BEYOND TECHNOLOGY CORPORATION NANCHANG
DISTRICT, NAN CHANG, JIANG XI,  CH.
Manufacturer;  
BEYOND TECHNOLOGY CORPORATION USA
DISTRICT, NAN CHANG, JIANG XI,  CH.
BEYONICS MFG. PTE. LTD.
SINGAPORE,  SN.
Contract Manufacturer;  
BEYONICS TECHNOLOGY LTD.
SINGAPORE,  SN.
BEZNOSKA S.R.O.
KLADNO 2,  EZ.
Manufacturer;  
BEZNOSKA S.R.O.
KLADNO 2,  EZ.
BG INDUSTRIES, LLC
NORTHRIDGE,  CA,  US.
Specification Developer;  
BG INDUSTRIES
NORTHRIDGE,  CA ,  US.
BG NORTH AMERICA
GLENDALE,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
BG NORTH AMERICA
GLENDALE,  CA ,  US.
BGC ENT., INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
BGC ENT., INC.
SAN DIEGO,  CA ,  US.
BHARAT ELECTRONICS LTD.
PASHAN PUNE,  IN.
Unregistered Foreign Lister;  
BHARAT ELECTRONICS LTD.
PASHAN PUNE,  IN.
BHAVI TUBES AND CONTAINERS PVT. LTD.
MEHSAMA,NG,RAKAN VILLAGE,  IN.
Manufacturer;  
BHAVI TUBES AND CONTAINERS PVT. LTD.
MUMBAI (BOMBAY) MAHARAJHTRA,  IN.
BHC INTERNATIONAL, LTD.
PETERBOROUGH, CAMBRIDGESHIRE,  UK.
Manufacturer;  
BHC INTERNATIONAL, LTD.
PETERBOROUGH, CAMBRIDGESHIRE,  UK.
BHH HUTA BAILDON
KATOWICE,  PL.
Unregistered Foreign Lister;  
BHH HUTA BAILDON
KATOWICE,  PL.
BHH MIKROMED
DABROWA GORNICZA,  PL.
Manufacturer;  
BHH HUTA BAILDON
KATOWICE,  PL.
BHK HOLDING
TAMPA,  FL,  US.
Initial Importer;  
BHK HOLDING
TAMPA,  FL ,  US.
BHM MEDICAL, INC.
MAGOG, QUEBEC,  CA.
Manufacturer;  
BHM MEDICAL, INC.
MAGOG, QUEBEC,  CA.
BHM-TECH PRODUKTIONSGESELLSCHAFT MBH
GRAFENSHACHEN,  AU.
Contract Manufacturer;  
BHM-TECH PRODUKTIONSGESELLSCHAFT MBH
GRAFENSHACHEN,  AU.
BHS INTL., INC.
CROFTON,  MD,  US.
Initial Importer;  
BHS INTL., INC.
CROFTON,  MD ,  US.
BIA YUNG OPTICAL FACTORY CHEUNG NING TOWN BOLUO CO
GUANGDONG,  CH.
Manufacturer;  
BRILIVISION MFG., LTD.
SAN PO KONG,  HK.
BIAFORM,INC.
ZEELAND,  MI,  US.
Initial Importer;  
BIAFORM,INC.
ZEELAND,  MI ,  US.
BIANCHI USA, INC.
HAYWARD,  CA,  US.
Initial Importer;  
BIANCHI USA, INC.
HAYWARD,  CA ,  US.
BIBBY STERILIN LTD.
MID GLAMORGAN,  UK.
Manufacturer;  
BIBBY STERILIN LTD.
WALTON, STONE, STAFFS,  UK.

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Last Modified: 29 April 2006
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