BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464054862·HEARLINK 2030 MNR T R BE/TP

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017989·K-Wire, Single Ended, Trocar Point, Diameter Si...

    BIO-CONNEKT WOUND MATRIX

    FDA 510(k)
    FDA Unclassified ·Unknown

    FLEBOSET MULTIPLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    QUICK FLEX LV LEAD

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

    2MM DIAMOND BALL, 15CM

    FDA Adverse Event
    Malfunction ·DEPUY SNTHES POWER TOOLS·Product code HBE·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