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

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    AUTOMATIC ENDOSCOPE

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

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172971109·

    JETi™Hydrodynamic Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 27, 2014

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 14, 2012

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·September 13, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015