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    Ingenia Elition and MR 7700 MR Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hemospray Endoscopic Hemostat

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code QAU·August 16, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code QAU·March 14, 2022

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 15, 2014

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011

    4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM

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

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Injury ·WILSON COOK MEDICAL INC.·Product code QAU·September 26, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code QAU·June 30, 2021

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code QAU·June 27, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code QAU·June 27, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code QAU·June 27, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code QAU·June 28, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code QAU·May 6, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Death ·WILSON-COOK MEDICAL INC·Product code QAU·June 28, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code QAU·June 6, 2022

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code QAU·June 27, 2022