BEUDAMED
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    DeepRhythmAI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464058860·OTICON MORE 3 MINIRITE T C063 DEMO

    VERTE-STACK K030736, K041197

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

    TruAbutment DS, TruBase S

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORNERSTONE-SR CAGE SYSTEM

    FDA Adverse Event
    Death ·MSD DEGGENDORF MFG·Product code ODP·February 17, 2012

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 9, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 2013

    ONE TOUCH ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·April 7, 2009

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014