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

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    IBC FLOPUMP, MODEL 6000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AI Rad Companion (Engine)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SKINCLEAR Q-SWITCHED ND:YAG LASER

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

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·June 16, 2009

    VASCUTRAK 2 PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·February 1, 2013

    CLARION IMPLANT

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·July 3, 2014

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

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

    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