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    SPIROLOOP-PULMONARY EXERCISE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO MODEL 750 SERIES MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PixoTest Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPRINT QUATTRO

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

    REVEAL DX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·October 9, 2010

    TAXUS® LIBERTÉ® ATOM¿

    FDA Adverse Event
    BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 10, 2012

    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 7, 2021

    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 VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MHX·March 23, 2021