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

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    AtriClip PRO-Mini LAA Exclusion System (PROM)

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

    Integrity™ Bone Staple Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArthroFree Wireless Surgical Camera System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 11, 2014

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 29, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2013

    PKG, DEBANEY FORCEPS, P/N 0250080314. 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