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

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    FIBREKOR POST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    GORE BIO-A FISTULA PLUG

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

    EP-TRACER System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 1, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 2, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 6, 2014

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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