BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    3M VITREBOND LIGHT CURE GLASS IONOMER/BASE

    FDA 510(k)
    FDA Class 2 ·Dental

    Ultrasound System SONIMAGE HS1

    FDA 510(k)
    FDA Class 2 ·Radiology

    RIVA LUTING PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·January 25, 2013

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·January 17, 2011

    POWERLINK SYSTEM

    FDA Adverse Event
    Death ·ENDOLOGIX, INC.·Product code MIH·July 28, 2014

    1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021