BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Transpara (2.1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HYDRAVIEW GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR

    FDA 510(k)
    FDA Class 2 ·Dental

    BD ANGIOCATH¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·April 26, 2019

    BD ANGIOCATH IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·July 14, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    VAUGHAN SOFT TISSUE PUNCH

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INSTRUMENTATION·Product code LRC·September 9, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·July 22, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    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