BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY

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

    KSEA DEPLOYABLE CARDIOVASCULAR CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORIGINALS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 14, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code JJE·December 3, 2010

    AU2700 CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·July 3, 2014

    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. 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