BEUDAMED
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    TOTAL PROTEINS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FERNORAL HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CANDELA 3630 LASER SYSTEM

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

    CAPSURE SENSE

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

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 9, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 10, 2012

    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, SpO2, Temp, Rec, Product Number 863074. 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, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

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

    Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, recording and alarming of multiple physiological parameters.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MHX·April 30, 2008

    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