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

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    URINE REAGENT STRIPS-8 PARAMETERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    InvisionECG System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 5, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 2, 2011

    PFC*SIGMA C/S NPOR FEM LT SZ 4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 18, 2014

    PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 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