BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    HAEMOPHILUS IDENTIFICATION TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EP DEFLECTABLE CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE

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

    TOTAL ASR FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 27, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEM INC.·Product code LZG·November 9, 2012

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code INK·September 9, 2010

    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

    FDA Enforcement
    Class I ·Ongoing·HeartWare Inc·May 20, 2015