BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Cala kIQ

    FDA 510(k)
    FDA Class 2 ·Neurology

    Intrisound™ Tuned Lumen® 155 Hearing Aids

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Medical nitrile examination gloves (Model: JL001)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 11, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·August 24, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2013

    BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·April 28, 2025

    TECNIS SIMPLICITY

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·February 7, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025