BEUDAMED
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    DW 235

    FDA 510(k)
    FDA Class 2 ·Dental

    MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)

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

    DRAINAGE CATHETERS W/A DISSOLVABLE TIP

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

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JGS·November 22, 2010

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 1, 2014

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023