BEUDAMED
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    Arthrex Radiopaque FiberTape Cerclage sutures

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAREO RETRACTABLE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SR-8230, SR-8230S Portable X-ray Unit

    FDA 510(k)
    FDA Class 2 ·Radiology

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·September 1, 2011

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·November 6, 2014

    4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWP·July 17, 2013

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023

    LIFE SCOPE PT

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026