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

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    9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DURAFLEX

    FDA 510(k)
    FDA Class 2 ·Dental

    BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code MBI·April 27, 2012

    RETROFLEX 3 INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·February 15, 2013

    UNKNOWN CONTINUUM HARD RIM BEARING IMPACTOR

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HWA·December 21, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 29, 2014

    3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·June 1, 2016