BEUDAMED
    7 results · 36ms · Sources: EU EUDAMED, US FDA

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    FlashHeal 2 (FlashHeal 2.0)

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

    GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET

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

    EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·November 6, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 2, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025