BEUDAMED
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    coactiv+™ Antimicrobial Wound Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERMANENT PACING LEAD, MODEL PY2

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL,INC.·Product code NAY·September 9, 2011

    530G INSULIN PUMP

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 22, 2013

    ARCOS 17X150MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    ARCOS CON SZ C STD 60MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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