BEUDAMED
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    SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 4, 2025

    SYRINGE CATH TIP BNS

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code KYZ·December 17, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·May 22, 2008

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·April 12, 2011

    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