BEUDAMED
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    MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Cortera Spinal Fixation System

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311209835·Tap, Solid, Iliac, 9.5

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001373·

    EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CYPRESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    G7 VIT E NEUTRAL LNR 36MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWZ·October 25, 2021

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·April 10, 2013

    OPTETRAK

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code JWH·April 1, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    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