BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    NUMED BALLOON THERMODILUTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T-PLUS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    6.0MM TI HARD ROD 50MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·June 18, 2014

    GORETEX

    FDA Adverse Event
    Injury ·Product code FTL·October 19, 2010

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·December 20, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024