BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACE SPORTS TAPE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VICTUS FEMTOSECOND LASER PLATFORM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PRE-POWDERED VINYL EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 11, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 4, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·December 29, 2010

    PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 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