BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509

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

    PLASMATRODE SALINE SAFE TUR ELECTRODE

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

    MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    QUIKDRIVE BATTERY POWERED SCREWDRIVER MINI

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·November 12, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HLTHCARE CORP·Product code FRN·January 14, 2014

    TOTALCARE BARIATRIC PLUS BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 28, 2012

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017