BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    TBC TRAUMA SUIT PROTECTIVE GOWN

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

    U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·January 18, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021