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    FDA 510(k)
    FDA Class 2 ·Radiology

    FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATLAS-BASED AUTOSEGMENTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022

    CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022

    CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 5, 2023

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 3, 2019

    WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 20, 2013

    NEBULIZER W/TEE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAF·April 29, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 22, 2008

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 5, 2022

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    CONTINU-FLO CLEARLINK SYSTEM SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 29, 2022

    FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM

    FDA Adverse Event
    Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

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