BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)

    FDA Enforcement
    Class II ·Terminated·Esaote S.p.A.·July 13, 2016

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·March 28, 2018

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·March 28, 2018

    MyLab Seven, Model 6400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Gamma, Model 7410

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Alpha, Model 7400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A·October 7, 2020

    AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A·October 7, 2020

    AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    FDA Recall
    Terminated ·ESAOTE S.P.A Via Enrico Melen·Product code IYN·September 8, 2020

    AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)

    FDA Recall
    Terminated ·ESAOTE S.P.A Via Enrico Melen·Product code IYN·September 8, 2020

    Esaote brand Formul@ ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand ArchiWin Colour ECG System; part 9704325000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand Archimed 4220 ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Esaote brand Formula for Archimed ECG System; part 9704220000.

    FDA Recall
    Terminated ·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003

    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)

    FDA Recall
    Terminated ·Esaote S.p.A. Via Di Caciolle, 15 Firenze Italy·Product code LNH·June 6, 2016

    MyLab Gamma, Model 7410

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·June 11, 2018

    MyLab Alpha, Model 7400

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·June 11, 2018

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·January 3, 2018

    MyLab Seven, Model 6400

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·June 11, 2018

    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·January 3, 2018