BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Eagle device

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIRCAST VENAFLOW ELITE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EQUINOXE PRIMARY SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·September 28, 2022

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·November 6, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·July 17, 2013

    SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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