BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    M.A.G. INC. HYPERINFLATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NOVASYS TRANSURETHRAL RF SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    POOL NORM

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIFECARE PCA 3 V4.1

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code MEA·November 15, 2010

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2014

    DEXTRUS 4135

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·December 27, 2012

    LIGACLIP ENDOSCOPIC ROTATING MCA

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 6, 2017

    PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 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