BEUDAMED
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    PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

    FDA 510(k)
    FDA Class 2 ·Radiology

    T2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·December 11, 2018

    NEXUS I.V. FLUID TRANSFER DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T2 XVBR 1.5 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·June 20, 2013

    SPACEMAKER BLUNT TIP TROCAR 12MM

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·August 4, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 7, 2011

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    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