BEUDAMED
    7 results · 36ms · Sources: EU EUDAMED, US FDA

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    MCA(TM) 130 HEMODIALYZER

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

    CK-MB IMMUNOASSAY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN DEPUY FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 30, 2010

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 6, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·July 21, 2014

    PKG, MIXTER FORCEPS, P/N 0250080285. 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