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

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    Innovasis Gibralt Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GRANDIO SO HEAVY FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    5MP MONOCHROME LCD MONITOR, RADIFORCE GX530

    FDA 510(k)
    FDA Class 2 ·Radiology

    COPIOS PERICARDIUM MEMBRANE

    FDA Adverse Event
    Injury ·Product code NPL·June 10, 2020

    UNKNOWN M2A MAGNUM HIP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 4, 2011

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LZG·October 22, 2014

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018