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

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    Histolog® Scanner (Hardware 2.4, Software 3.3)

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

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517443977·SpheRx® II Conn, 27.5mm Transverse Fixed

    LCP

    FDA UDI
    Synthes GmbH·10886982166418·3.5MM LCP® POSTEROLATERAL DSTL HUMERUS PL-LAT S...

    ENDOPHYS PRESSURE SENSING SHEATH KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROCERA ABUTMENT OCTAGON

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 18, 2015

    HUDSON CIRCUIT, NEONATAL, DUAL HTD LUMB W/18 IN

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAI·August 19, 2011

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·November 21, 2008

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·July 22, 2013

    MERIDIAN FILTER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 21, 2019

    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