BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    DENTAL RUBBER DAM

    FDA 510(k)
    FDA Class 1 ·Dental

    SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CLAVICLE SUPPORT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code HET·January 18, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 9, 2010

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 9, 2014

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025