BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ActivSight Intraoperative Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 11, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MDS·September 2, 2011

    4.5MM CORTEX SCREW SELF-TAPPING 40MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KTT·July 23, 2013

    PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 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