BEUDAMED
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    MAGNESIOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION

    FDA 510(k)
    FDA Unclassified ·Unknown

    OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

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

    VIVA XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 10, 2012

    ALTRX NEUT 40IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 23, 2015

    Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

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

    SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·May 22, 2019

    SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code MHX·April 19, 2019

    Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

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

    Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VS3 vital signs monitor and 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. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DPS·June 10, 2011