BEUDAMED
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    RelieVRx

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANAX 5.5 Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DVT-4000S

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE 02.12.E0511FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 27, 2023

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·November 11, 2014

    COGNIS

    FDA Adverse Event
    Death ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·September 12, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·July 23, 2013

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2023

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016