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

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    EXTEMP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MONITOR, PORTABLE, PATIENT, G.E.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TAPERLOC COMPLETE FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 8, 2018

    TPRLC 133 T1 PPS HO 12X144MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 8, 2018

    FUSION OMNI-TOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·October 1, 2012

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·April 24, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·July 28, 2010

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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