BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    AquaShield system CO2, AquaShield system-PENTAX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222113·

    CELL-CHEX AUTO

    FDA 510(k)
    FDA Class 2 ·Hematology

    AOI CRANIAL HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD PHOENIX¿ NID

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LQM·March 2, 2022

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 8, 2014

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013

    OCTRODE 30-CM LENGTH PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011

    ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023