BEUDAMED
    5 results · 43ms · Sources: EU EUDAMED, US FDA

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    TRUE DILATATION

    FDA Adverse Event
    LOMA VISTA MEDICAL·Product code OZT·March 12, 2014

    TRUE DILATATION

    FDA Adverse Event
    Injury ·LOMA VISTA MEDICAL·Product code OZT·February 20, 2015

    TRUE DILATATION BALLOON VALVULOPLASTY CATHERTER

    FDA Adverse Event
    Malfunction ·LOMA VISTA MEDICAL, INC.·Product code OZT·March 27, 2013

    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.

    FDA Recall
    Terminated ·Loma Vista Medical·Product code OZT·March 18, 2013

    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.

    FDA Enforcement
    Class II ·Terminated·Loma Vista Medical·July 3, 2013