BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARFLASH AC2100 COSMETIC SYSTEM

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

    TRULINE INFUSION CATHETERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP·Product code DSQ·August 10, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 8, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021