BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    LIGHTSCALPEL LS-4020

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRANSTEK WRIST BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mobius3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    MENTOR CORP SALINE BREAST IMPLANTS 350CC

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code FWM·January 31, 2019

    COBAS® MPX - 96T

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·October 23, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019