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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
AMBU A/S
OLSTYKKE,  DA.
Manufacturer;  
AMBU A/S
BALLERUP,  DA.
AMBU INC.
GLEN BURNIE,  MD,  US.
Initial Importer;   Manufacturer;  
AMBU A/S
BALLERUP,  DA.
AMBU LTD.
XIANG YU F.T.Z., XIAMEN,  CH.
Contract Manufacturer;  
AMBU A/S
BALLERUP,  DA.
AMBU OF 2003 SDN. BHD.
BAYAN LEPAS FIZ,PH.1,PENANG,  MY.
Contract Manufacturer;  
AMBU A/S
BALLERUP,  DA.
AMBU SDN.BHD.
PENANG,  MY.
Contract Manufacturer;  
AMBU A/S
BALLERUP,  DA.
AMBULATION APPLIANCES
SIERRA VISTA,  AZ,  US.
Manufacturer;  
AMBULATION APPLIANCES
SIERRA VISTA,  AZ ,  US.
AMBULATORY MONITORING, INC.
ARDSLEY,  NY,  US.
Specification Developer;   Repackager/Relabeller;  
AMBULATORY MONITORING, INC.
ARDSLEY,  NY ,  US.
AMBUSCO CO., INC.
NEW CITY,  NY,  US.
Initial Importer;  
AMBUSCO CO., INC.
NEW CITY,  NY ,  US.
AMBUTECH
WINNIPEG, MB,  CA.
Manufacturer;  
MELET PLASTICS, INC.
WINNIPEG, MB,  CA.
AMBUTECH, INC.
GRAND FORKS,  ND,  US.
Initial Importer;  
MELET PLASTICS, INC.
WINNIPEG, MB,  CA.
AMC GENERAL, INC.
SAVANNAH,  GA,  US.
Initial Importer;   Specification Developer;  
BRASSELER USA I, L.P.
SAVANNAH,  GA ,  US.
AMC GLOBAL, INC.
MILPITAS,  CA,  US.
Initial Importer;   Specification Developer;  
AMC GLOBAL, INC.
MILPITAS,  CA ,  US.
AM-CAN DISTRIBUTION, INC.
BURR RIDGE,  IL,  US.
Initial Importer;  
AM-CAN DISTRIBUTION, INC.
BURR RIDGE,  IL ,  US.
AMCOR FLEXIBLES
COULOMMIERS,  FR.
Manufacturer;   Specification Developer;  
AMCOR, LTD.
ABBOTSFORD, VICTORIA,  AS.
AMCOR FLEXIBLES HEALTHCARE, INC.
MADISON,  WI,  US.
Manufacturer;  
AMCOR LIMITED
ABBOTSFORD, VICTORIA,  AS.
AMCOR FLEXIBLES HEALTHCARE, INC.
MUNDELEIN,  IL,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMCOR LIMITED
ABBOTSFORD, VICTORIA,  AS.
AMCOR, INC.
CARLSTADT,  NJ,  US.
Initial Importer;  
AMCOR INTERNATIONAL LTD.
HERZLIYA PITUACH,  IS.
AMD RITMED, INC.
LACHINE, QUEBEC,  CA.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMD RITMED, INC.
LACHINE, QUEBEC,  CA.
AMD RITMED, INC. (GRANBY PLANT)
GRANBY, QUEBEC,  CA.
Foreign Exporter;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
AMD RITMED, INC.
LACHINE, QUEBEC,  CA.
AMD TELEMEDICINE, INC.
LOWELL,  MA,  US.
Specification Developer;  
AMD TELEMEDICINE, INC.
LOWELL,  MA ,  US.
AMDA ENTERPRISES, INC.
WILBRAHAM,  MA,  US.
Initial Importer;  
AMDA ENTERPRISES, INC.
WILBRAHAM,  MA ,  US.
AMDEN CORP.
LAS VEGAS,  NV,  US.
Manufacturer;  
AMDEN CORP.
LAS VEGAS,  NV ,  US.
AMDENT AB
NYNASHAMN,  SW.
Manufacturer;  
AMDENT AB
NYNASHAMN,  SW.
AMDEV, INC.
WEST PEABODY,  MA,  US.
Manufacturer;  
AMDEV, INC.
WEST PEABODY,  MA ,  US.
AMDL, INC.
TUSTIN,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMDL, INC.
TUSTIN,  CA ,  US.
AMD-RITMED, INC.
TONAWANDA,  NY,  US.
Initial Importer;  
AMD-RITMED, INC.
TONAWANDA,  NY ,  US.
AMDX MEXICO, S. DE R.L. DE C.V.
MEXICO, DISTRITO FEDERAL,  MX.
Contract Manufacturer;   Manufacturer;  
AMDX MEXICO, S. DE R.L. DE C.V.
MEXICO, DISTRITO FEDERAL,  MX.
AMDX, LLC
MIAMI,  FL,  US.
Initial Importer;  
PHARMED GROUP HOLDINGS, INC.
MIAMI,  FL ,  US.
AMDX,INC.
MIAMI,  FL,  US.
Initial Importer;  
AMDX,INC.
MIAMI,  FL ,  US.
AME
LOS ANGELES,  CA,  US.
Specification Developer;  
AME
LOS ANGELES,  CA ,  US.
AME INT'L.
MIAMI,  FL,  US.
Repackager/Relabeller;  
AME INT'L.
MIAMI,  FL ,  US.
AME MANUFACTURING, INC.
POMONOA,  CA,  US.
Initial Importer;  
AME MANUFACTURING, INC.
POMONOA,  CA ,  US.
AMECO MEDICAL INDUSTRIES
10TH OF RAMADAN CITY,  EG.
Foreign Exporter;   Manufacturer;  
AMECO MEDICAL INDUSTRIES
10TH OF RAMADAN CITY,  EG.
A-MED 2000
MT. LAUREL,  NJ,  US.
Initial Importer;  
A-MED 2000
MT. LAUREL,  NJ ,  US.
A-MED INTL. SUPPLY, INC.
BROOKLYN,  NY,  US.

A-MED INTL. SUPPLY, INC.
BROOKLYN,  NY ,  US.
AMED SOLUTIONS CORP.
MIAMI,  FL,  US.
Initial Importer;  
AMED SOLUTIONS CORP.
MIAMI,  FL ,  US.
A-MED SYSTEMS, INC.
WEST SACRAMENTO,  CA,  US.
Manufacturer;  
A-MED SYSTEMS, INC.
WEST SACRAMENTO,  CA ,  US.
AMEDA INSTRUMENTS CO.
KARACHI,  PK.
Contract Manufacturer;  
AMEDA INSTRUMENTS CO.
KARACHI,  PK.
AMEDCO CORP.
MIAMI,  FL,  US.
Initial Importer;  
AMEDCO CORP.
MIAMI,  FL ,  US.
AMEDICA BIOTECH, INC.
HAYWARD,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
AMEDICA BIOTECH, INC.
HAYWARD,  CA ,  US.

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Last Modified: 29 April 2006
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