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

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    Droplet Pen Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 20, 2025

    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    US ENDOSCOPY CYTOLOGY BRUSH

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

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 6, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·June 3, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 29, 2011

    PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. 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