BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    BVN

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AcQMap

    FDA UDI
    ACUTUS MEDICAL, INC.·00850027837222·AcQMap to SmartAblate Generator Adapter

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776123758·Malis Type Biopolar Forcep

    ACUMED

    FDA UDI
    Acumed LLC·10806378044083·Acu-Loc® 2 VDR T-Guide Std L

    GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOBILE I.V. SYSTEMS 10,20,60

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 7, 2007

    Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.

    FDA Recall
    Terminated ·Ergosafe Products LLC DBA Prism Medical Services USA·Product code FSA·October 30, 2013

    Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.

    FDA Recall
    Terminated ·Ergosafe Products LLC DBA Prism Medical Services USA·Product code FSA·October 30, 2013

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021