BEUDAMED
    7 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SHADOW-CATHS

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

    MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)

    FDA 510(k)
    FDA Unclassified ·Unknown

    ELECSYS ANTI-TSHR CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·October 5, 2012

    ACCU-CHEK ADVANTAGE II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 27, 2007

    Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024