BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    GC OPB-100

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300

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

    SOLA 700,SOLA 500, SOLA 300

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

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 10, 2024

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 9, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 6, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 23, 2008

    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.

    FDA Enforcement
    Class II ·Ongoing·Med Michigan Holding Llc·January 8, 2025