BEUDAMED
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    EsoCool Thermal Regulation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACQSIM-MULTISLICE-CT, MODEL 453567042271

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHARRUAPACS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    EQUINOXE REVERSE 38MM GLENOSPHERE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·July 14, 2023

    XPERT SELF-EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code FGE·November 6, 2014

    APOLLO

    FDA Adverse Event
    Malfunction ·DRAEGER MEDICAL GMBH·Product code BSZ·August 29, 2011

    NIMBUS 4

    FDA Adverse Event
    Injury ·GETINGE (SUZHOU) CO. LTD·Product code FNM·July 11, 2013

    Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

    Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 software. The Brilliance Big Bore and Brilliance 64 are Computed Tomography X-Ray Systems intended thio product cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011