BEUDAMED
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    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185035·Kelvi Back Pro Smart Wrap

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185110·Kelvi Hip Pro Smart Wrap, Right

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185073·Kelvi Hand Station

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185011·Kelvi Pro Umbilical

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185059·Kelvi Ankle Pro Smart Wrap

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185004·Kelvi Pro Console

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185028·Kelvi Shoulder Pro Smart Wrap

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185042·Kelvi Knee Pro Smart Wrap

    Kelvi

    FDA UDI
    HYPOTHERMIA DEVICES, INC.·00850001185103·Kelvi Hip Pro Smart Wrap, Left

    HYPOTHERMIA DEVICES INC. (DBA KELVI)

    FDA Adverse Event
    Malfunction ·HYPOTHERMIA DEVICES INC·Product code ILO·June 30, 2023

    KELVI

    FDA Adverse Event
    Injury ·HYPOTHERMIA DEVICES INC.·Product code ILO·December 5, 2022

    ARCTIC SUN® 5000

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·February 25, 2022

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·September 3, 2013

    WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·June 1, 2011

    THERMOSUIT SYSTEM

    FDA Adverse Event
    Death ·LIFE RECOVERY SYSTEMS HD, LLC·Product code NZE·August 31, 2011

    640G INSULIN PUMP MMT-1712K

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2022

    XMTR MMT-7811XWW GST3C OUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZP·June 9, 2023

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 11, 2023

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 15, 2022