BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    InnoClip Disposable Clip Applier

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

    Cuticell®

    FDA UDI
    BSN medical GmbH·04042809224269·CUTICELL STERILE 7.5CMX20CM 1

    Zeta Cranial Navigation System (ZNS131-US)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 19, 2011

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 30, 2013

    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