BEUDAMED
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    BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122994·K-WIRE - SINGLE TROCAR 1.4mm DIA x 150mm

    NEURO VISION RADIOGRAPHIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    84 CHANNEL EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2015

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·December 3, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE·Product code FKX·July 3, 2014

    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc·July 3, 2019