BEUDAMED
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    Dimesol Tubing Sets for Hemodialysis

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GRAFTLOCK SCREW, ST SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KONIX ULTRASOUND GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 7, 2013

    SENSIA SR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·July 22, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 19, 2008

    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·February 13, 2023

    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

    FDA Enforcement
    Class I ·Ongoing·Abbott Diabetes Care, Inc.·April 12, 2023

    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