BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    Aptima CV/TV Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Oticon

    FDA UDI
    Oticon A/S·05707131339034·SIYA 1, MINIRITE T 312 2.4G C090

    GRIND GUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    SI-FIX SACROILIAC JOINT FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 17, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 26, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 21, 2014

    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