BEUDAMED
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    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    FDA Enforcement
    Class III ·Terminated·Alivecor SFO·February 25, 2015

    MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

    FDA Enforcement
    Class III ·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·August 28, 2019