BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    Omnifix Low Dead Space Luer Lock Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    Manifold

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333206964·2 Port Manifold - Right/On/Open Body - 500 PSI

    MAGO 4S

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2024

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 6, 2008

    HUDSON SPIRAL-FLEX ENDOTRACHEAL TUBE, 7.5MM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTR·June 21, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011

    BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 9, 2021

    Quanta System Sterile Optical Laser Fiber, reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021