9 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Enforcement
Class II
·Completed·ESAOTE S.P.A.·March 11, 2026
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