BEUDAMED
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    VINTAGE PRO

    FDA 510(k)
    FDA Class 2 ·Dental

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776297602·Enucleation Scissors 5" Medium Curve

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362128·Integra® Miltex® Enucleation Scissors, 5", Medi...

    OPTIMA PET/CT 560

    FDA 510(k)
    FDA Class 2 ·Radiology

    CABLECAP MODEL: WLF, STZ, ACM

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

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·December 19, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    SYSTEM, PERITONEAL AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 21, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    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