BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    SINGLE WALL INTRODUCER NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aeroneb USB Contoller System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AML (ANGLE MAGNIFYING LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 2, 2014

    X-STREAM

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC.·Product code GCJ·October 26, 2012

    TOTALCARE-TREAT SURFACE&SCALE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·September 21, 2010

    PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015