BEUDAMED
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    RayStation 11.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·October 22, 2008

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·August 10, 2011

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 8, 2013

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·May 27, 2025

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025