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    ACUFEX SURETAC IXC SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·September 19, 2025

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MHX·April 4, 2022

    INTELLIVUE MX40 WLAN

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code DSI·June 27, 2023

    PAGEWRITER

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code DPS·June 13, 2025

    PIC IX C ST EFP

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MHX·October 5, 2022

    PIC IX C ST EFP

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 22, 2023

    PIC IX C ST EFP

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MHX·April 28, 2022

    PIC IX C ST EFP

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MHX·July 9, 2021

    INTELLIVUE INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 7, 2020

    PIC IX C ST RP5810 PC

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MHX·January 19, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MHX·December 2, 2022

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 10, 2024

    MAMMOLUX 1360

    FDA Adverse Event
    Other ·R2 TECHNOLOGY, INC.·Product code IXC·March 21, 2006

    MOTORIZED X-RAY FILM VIEWER

    FDA Adverse Event
    Other ·S&S X-RAY PRODUCTS, INC.·Product code IXC·March 26, 1997

    *

    FDA Adverse Event
    Malfunction ·CARR CORP.·Product code IXC·December 16, 1998

    PIC IX HARDWARE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 11, 2023

    PIC IX HARDWARE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 23, 2023

    Illuminator, Radiographic-Film

    FDA classification
    FDA Class 1 ·Illuminator, Radiographic-Film

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020