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

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    IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PANGEA

    FDA UDI
    Stryker GmbH·07613327414301·Instrument Tray ORIF

    NuFACE® FIX+

    FDA 510(k)
    FDA Class 2 ·Neurology

    BN LUMBAR CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPERATING CYSTOSCOPE-URETHROSCOPE

    FDA Adverse Event
    Death ·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·December 21, 2010

    PERIGEE SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 30, 2013

    VARIAX DR AIMING BLOCK FIXATION PIN

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG (MDR)·Product code HRS·July 17, 2014

    PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. 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