BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    Ulike Reglow Light Therapy Device (UM10)

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

    OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Instrument tray, for semi-rigid ureteroscope

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 11, 2014

    CHARGER

    FDA Adverse Event
    Malfunction ·LIKO AB·Product code FSA·August 19, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 23, 2013

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024