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

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    MEDI STRUMPF

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM

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

    PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·December 23, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·December 21, 2012

    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