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

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    pREBOA-PRO Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Temporary Abutment

    FDA UDI
    BICON, LLC·00813110029607·4.0 x 2.5mm Scannable Temporary Abutment - 2.5m...

    Videa Caries Assist

    FDA 510(k)
    FDA Class 2 ·Radiology

    Star RF Electrode, VIVA RF Electrode

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    ONE TOUCH ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 12, 2011

    TRIATHLON PS FEM COMPONENT, CEMENTED

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 23, 2013

    PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 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