BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    PeriBeam® Pericardial Membrane

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015375534·REVISION LOCKING SCREW L77.5MM D4.0MM

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015375039·REVISION LOCKING SCREW L77.5MM D4.0MM STERILE

    TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEPAK 12

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OPTETRAK HI-FLEX TIBIAL INSERT SZ 5 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 17, 2024

    CURRENT PLUS DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 2013

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·May 20, 2024

    HLS SET ADVANCED 7.0

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·December 9, 2020

    HEARTMATE 3 VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 1, 2022

    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