BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Achieve Advance Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

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

    EUKARE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit

    FDA Enforcement
    Class I ·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·October 10, 2014

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 11, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025