BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

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    Atlas™ Humeral Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNDECIDED

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPEN FMSEALER

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

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 12, 2022

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 4, 2022

    DENTAL PLACEMENT TOOL

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NDP·September 10, 2021

    ENSITE CLASSIC SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

    BIPAP SYNCHRONY ST

    FDA Adverse Event
    Death ·RESPIRONICS INC·Product code MNS·November 21, 2008

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 22, 2013

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 5, 2023

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014