BEUDAMED
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    Prime&Bond active Universal Adhesive

    FDA 510(k)
    FDA Class 2 ·Dental

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362043·Integra® Miltex® Stevens Tenotomy Scissors, 4-1...

    CONTOUR TECHNOLOGY MUSCLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE

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

    RUSCH

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code KOD·May 11, 2013

    UNKNOWN TM SPINE IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER TMT·Product code KWA·August 28, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 5, 2011

    DEKA MOTUS AY

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019

    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