BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    PowerGlide Pro™ Midline Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017972·K-Wire, Single Ended, Trocar Point, Diameter Si...

    HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    MAXIMIS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    2.15MM X 22MM SPIRAL ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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