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

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    VENTILATORY EFFORT MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SFC VERTEBRAL BODY REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    X-spine Cortical Bone Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 20, 2010

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024