BEUDAMED
    14 results · 33ms · Sources: EU EUDAMED, US FDA

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    STAIRMASTER MODEL 6000 ERGOMETER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080808·Tubular Sleeve

    PICCOLO BASIC METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

    COM-PATCH

    FDA 510(k)
    FDA Class 2 ·Neurology

    7D Surgical System

    FDA 510(k)
    FDA Class 2 ·Neurology

    GII QA+ O/C CP-2 *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code JDR·January 29, 2019

    GII QA+ O/C CP-2 *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code JDR·January 29, 2019

    HS III PROXIMAL SEAL SYTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 13, 2014

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·January 11, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 2, 2010

    ORTHOPEDIC SALVAGE SYSTEM ARCOM LS TIBIAL BEARING 12MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·July 20, 2022

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017