BEUDAMED
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    STERLING INTERFERENCE SCREW ST

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

    INSERTER-MEDIUM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·April 10, 2013

    RIATA ST OPTIM PASSIVE FIXATION

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

    CAPSURE SENSE

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

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

    BD PHOENIX SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 6, 2021

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 12, 2024

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    BD PHOENIX¿ SMIC/ID-101

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026

    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