BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    CHAIR, ADJUSTABLE, MECHANICAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Offset Reamer Handle - Large AO - Dual Coupling

    FDA UDI
    Incipio Devices SA·07630055302939·Offset Reamer Handle for hip arthroplasty

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123281·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 150mm

    K-Y BRAND LIQUIBEADS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINIARC SINGLE-INCISION SLING

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 4, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·December 13, 2010

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 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