BEUDAMED
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    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·August 31, 2021

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·June 8, 2021

    BAROSTAT SOFTWARE OPTION

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

    DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 30, 2011

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 14, 2013

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·August 20, 2018

    Ingenia 1.5T- 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: 781341 781396

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