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

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    butterflyBVM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Libre Rio Continuous Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CER-S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    SPACEMAKER BLUNT TIP TROCAR 12MM

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GCJ·November 11, 2014

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·August 24, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·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