BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medical surgical mask

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

    NOVATION 12/14 PRESS-FIT FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 15, 2018

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 19, 2013

    KOH-EFFICIENT,RUMI,3.0CM

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HEW·October 12, 2018

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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