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

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    QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023

    STINGRAY ORIENTING BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·June 11, 2013

    ATTAIN STABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code OJX·October 10, 2014

    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017