BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    ST-4 COAGULATION INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    BUSSE BAC/SHIELD

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERGLIDE

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS, INC.·Product code FOZ·June 26, 2014

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MLM·January 9, 2013

    EON 16-CHANNEL IPG

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·January 30, 2025

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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