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

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    Filters Regulation: Us FDA ×

    Erchonia EVRL

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ADVANCED TRAUMA DRESSING (ATD)

    FDA 510(k)
    FDA Unclassified ·Unknown

    MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Death ·DEXCOM, INC.·Product code MDS·June 3, 2015

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·July 19, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MPRI·Product code DTB·June 26, 2013

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 26, 2008

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 14, 2015

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

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