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

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    PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROCEDURE KIT/ROUTINE DENTAL PROCEDURES

    FDA 510(k)
    FDA Class 1 ·Dental

    PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code PAH·February 6, 2013

    MONOPOLAR CURVED SCISSOR

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL INC·Product code NAY·December 21, 2010

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·July 1, 2014

    PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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