BEUDAMED
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    DA VINVI SURGICAL SYSTEM

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

    DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    K2M, PYRENEES CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTIS Q ZEEGO

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 21, 2013

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 26, 2014

    PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 8, 2011

    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 1, 2023