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

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    RENALIN (TENTATIVE

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

    Limbus Contour

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO SOLAR 9500 INFORMATION MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEMI

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBZ·May 23, 2014

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 13, 2012

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 3, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018