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

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    REMOTE CONTROL RADIOISOTOPE APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ROCHE REAGENT FOR AST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    XP300

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

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·December 30, 2010

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 21, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2014

    PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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