BEUDAMED
    4 results · 71ms · Sources: EU EUDAMED, US FDA

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    ACCUTRAC PH-Z PRECISION REFLUX MONITORING

    FDA Adverse Event
    Malfunction ·SIERRA SCIENTIFIC INSTRUMENTS, INC.·Product code FFT·December 8, 2009

    MANOSHIELD BY SIERRA

    FDA Adverse Event
    SIERRA SCIENTIFIC INSTRUMENTS, INC.·Product code FFX·March 4, 2009

    HIGH RESOLUTION ESOPHAGEAL MANOMETRY-PC

    FDA Adverse Event
    Malfunction ·SIERRA SCIENTIFIC INSTRUMENTS, INC.·Product code FFX·July 28, 2010

    AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.

    FDA Recall
    Terminated ·Sierra Scientific Instruments Inc·Product code FFX·October 12, 2011