BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    SonoBlock; SonoBlock II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DISPOSABLE MONITORING ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XCEL 455 SLIT LAMP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·November 15, 2021

    RAYONE TORIC

    FDA Adverse Event
    Malfunction ·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·October 2, 2024

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 10, 2014

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code MGB·September 9, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013

    PKG, BABCOCK FORCEPS, P/N 0250080321. 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