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

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    CORE Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Disposable Medical Face Mask

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

    MORTON IUI CATHETERS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 20, 2024

    SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·November 10, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    PLASTI ESTERIL, S.A. DE C.V.·Product code FKX·September 9, 2011

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 22, 2013

    XP-XP Tibial Tray - Interlok 73 mm Item # 195756

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024