BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    RESTORATION ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFINITY GATEWAY SUITE, VF4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vivorte Trabexus

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·April 30, 2014

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 5, 2013

    SP2 IM ROD 400MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·November 30, 2010

    PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014