BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    TELEMANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Extremity Medical Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COULTER AC·T DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 5, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2010

    TOPAZ MICRODEBRIDER WITH INTEGRATED FINGER SWI

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·November 21, 2012

    MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code N/A·April 30, 2020

    Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code OZP·November 21, 2019

    MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code OZO·April 30, 2020

    Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code OZO·November 21, 2019

    Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code OZP·November 21, 2019

    Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code OZP·November 21, 2019

    MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code OZP·April 30, 2020