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    MuellerMedical Infrared Ear/Forehead Thermometer IT-800

    FDA UDI
    DOCTOR BEST PRODUCT·00860004898627·

    MuellerMedical Infrared Forehead Thermometer IT-700

    FDA UDI
    DOCTOR BEST PRODUCT·00860004898610·

    MuellerMedical Digital Thermometer

    FDA UDI
    DOCTOR BEST PRODUCT·00860004898603·

    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·September 26, 2012

    530G INSULIN PUMP MMT-751NAS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 8, 2017

    INTRALASE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·March 21, 2013

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·November 30, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 6, 2016

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·September 17, 2015

    MODEL NOT SPECIFIED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·June 19, 2012

    INTRALASE

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code HNO·September 12, 2017

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 8, 2016

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·December 2, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·November 18, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 19, 2016

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·December 30, 2015

    RESERVOIR 3ML

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·February 8, 2017

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 25, 2012

    INTRALASE

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HNO·June 29, 2018