BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    Revolution CT

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code JAK·March 19, 2021

    microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059

    FDA Recall
    Completed ·Product code LHO·February 8, 2024

    A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol

    FDA Recall
    Completed ·Pintler Medical LLC·Product code DWJ·April 20, 2018

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Enforcement
    Class II ·Completed·Augustine Temperature Management, LLC·January 22, 2025