BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    CSS-CARDIOPLEGIA SAFETY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REHASTIM & REHAMOVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

    FDA 510(k)
    FDA Unclassified ·Unknown

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTN·February 21, 2013

    RESOLUTION CLIP CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·August 1, 2014

    MINI-CAP WITH POVIDONE LODINE

    FDA Adverse Event
    Malfunction ·Product code KDI·January 28, 2011

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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