BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACKRAD RETROGRADE URETHROGRAPHY SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ME-TOO OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ASSERACHROM IX:AG

    FDA 510(k)
    FDA Class 2 ·Hematology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 18, 2014

    JELCO HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FMI·October 11, 2010

    PROMUS ELEMENT ¿ LONG

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 14, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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