BEUDAMED
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    Aria Universal Mini Valve Key

    FDA UDI
    CYPRESS ADAPTIVE, LLC·00850013242887·Tool to install or remove valves for prosthesis...

    ACCESS CARDIO

    FDA Adverse Event
    Death ·ACCESS CARDIOSYSTEMS·Product code MVK·November 18, 2003

    INRATIO

    FDA Adverse Event
    Injury ·ALERE SAN DEIGO, INC·Product code GJS·February 27, 2014

    Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·October 21, 2008

    Model 4000 Monitor component of the LifeVest Wearable Defibrillator

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·September 24, 2010

    Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·April 27, 2007

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Manufacturing Corp.·Product code MVK·September 12, 2017

    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·September 14, 2007

    Wearable Automated External Defibrillator

    FDA classification
    FDA Class 3 ·Wearable Automated External Defibrillator

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 18, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 19, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 28, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 11, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 23, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·December 16, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·December 16, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 26, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 30, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·December 28, 2016

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 14, 2016