BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Bernafon AG·05711584087534·ZR1, KIT IIC 10 75 BL ZERENA 1

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776199968·Insulated View More Speculum small

    COMBITRANS MONITORING SETS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR

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

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·August 4, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 20, 2013

    ENDURON 10D 56 OR 68ODX28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HRY·October 6, 2008

    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