BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    Gynethotics™ Pessary

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM

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

    AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 1, 2011

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022