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

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    LUMIN

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonendo GentleWave System

    FDA 510(k)
    FDA Class 2 ·Dental

    Equinoxe® Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 5, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 2, 2011

    UNIDENTIFIED SIGMA UNI INSTRUMENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code LXH·July 18, 2014

    PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. 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