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

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    DUET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER

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

    DIMENSION PENTA H, DIMENSION PENTA H QUICK

    FDA 510(k)
    FDA Class 2 ·Dental

    ISODUR PROSTHESIS HEAD 12/14 28MM M

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015

    PERMOBIL M300 CORPUS 3G

    FDA Adverse Event
    Malfunction ·PERMOBIL, INC.·Product code ITI·March 12, 2013

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·May 9, 2008

    CONSULTA CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code NIK·April 6, 2011

    PKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266. 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