BEUDAMED
    3 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Ongoing × Clear all

    Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·July 3, 2024

    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

    FDA Enforcement
    Class I ·Ongoing·HeartWare Inc·May 20, 2015

    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

    FDA Enforcement
    Class I ·Ongoing·Heartware·May 3, 2017