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

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    AUTOMATIC TEFLON INJECTION SYRINGE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)

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

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·April 25, 2014

    VANGRD ANT STBLZD BRG 12X63.5

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·October 31, 2012

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 20, 2010

    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