BEUDAMED
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    HYDROPHILIC REPROSIL

    FDA 510(k)
    FDA Class 2 ·Dental

    SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pelvifine Pelvic Muscle Trainer

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CAPSURE SP NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 9, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 10, 2012

    Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature

    FDA Enforcement
    Class II ·Ongoing·Philips Electronics North America Corporation·August 29, 2018

    Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature

    FDA Recall
    Open, Classified ·Philips Electronics North America Corporation·Product code MHX·July 13, 2018