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

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    ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESSORIES

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

    GME ExSys 308

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

    AESCULAP ORTHOPILOT 2 THA V 2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 8, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 6, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2014

    GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL (MDR)·Product code LXH·May 29, 2015

    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