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

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    Vassallo GT 018 Hybrid

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDLINE ASEP PLUS SURGICAL DRAPES

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

    Axium Detachable Coil; Axium Prime Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNKNOWN BIGLIANI/FLATOW HUMERAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code HSD·October 29, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2011

    HELICAL BLADE INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code LXH·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026