BEUDAMED
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    PERMOBIL F3

    FDA Adverse Event
    Injury ·PERMOBIL INC.·Product code ITI·April 12, 2017

    BRILLIANCE AIR 40/64/UCT

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·July 24, 2018

    BRILLIANCE AIR 40/64/UCT

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·July 24, 2018

    AXIOM ARTIS ZEE BIPLANE

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IZI·June 23, 2008

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·February 11, 2013

    BRILLIANCE AIR 40/64/UCT

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·July 31, 2018

    SOMATOM GO.ALL

    FDA Adverse Event
    Injury ·SIEMENS HEALTHCARE GMBH·Product code JAK·April 19, 2022

    ROTABLATOR GUIDE WIRE

    FDA Adverse Event
    Injury ·SCIMED, A DIVISION OF BOSTON SCIENTIFIC CORP.·Product code DQX·March 20, 1998

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION INC.·Product code DRM·February 11, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 15, 2010

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·August 24, 2016

    Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

    FDA Enforcement
    Class II ·Ongoing·Omega Medical Imaging, Inc.·November 1, 2023

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·June 21, 2017

    Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

    FDA Enforcement
    Class II ·Ongoing·Omega Medical Imaging, Inc.·November 1, 2023

    SOMATOM SENSATION 64

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code JAK·June 21, 2007

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 23, 2016

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 23, 2016

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK INC.·Product code MIH·September 9, 2008

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 10, 2017

    PENUMBRA SYSTEM ACE 60 HI-FLOW KIT

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·September 6, 2016