BEUDAMED
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    SIRA™ RFA Electrosurgical Device

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

    NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 22, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    KINDEST KARE FOAM ANTISEPTIC HANDRUB

    FDA Adverse Event
    STERIS CORPORATION·Product code LRJ·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025