BEUDAMED
    10 results · 33ms · Sources: EU EUDAMED, US FDA

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    Norm-O-Temp model 111Z

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·June 20, 2019

    Norm-O-Temp model 111W

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·June 20, 2019

    Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019

    Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019

    CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019

    Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

    FDA Recall
    Terminated ·Gentherm Medical, LLC·Product code ILO·November 22, 2021

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

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code ILO·July 19, 2019

    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

    FDA Recall
    Terminated ·Gentherm Medical, LLC·Product code DWC·June 17, 2021

    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures

    FDA Enforcement
    Class II ·Terminated·Gentherm Medical, LLC·July 28, 2021

    Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

    FDA Enforcement
    Class II ·Terminated·Gentherm Medical, LLC·January 19, 2022