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

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    HD60 Series Ultrasound Diagnostic System

    FDA 510(k)
    FDA Class 2 ·Radiology

    BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIO PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOSPHERE FORESIGHT MODULE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·October 28, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 5, 2011

    PELVISOFT COLLAGEN ACELLULAR BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·July 3, 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