BEUDAMED
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    PowerMidline Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDER FREE BLACK NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POLARIS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    FDA Adverse Event
    Injury ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·June 29, 2011

    CAPSURE SP 4024

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 8, 2013

    11CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 8, 2014

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023