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

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    RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultra-Care Pen Needles 32G 5/32" 100 Ct

    FDA UDI
    ARISE MEDICAL LLC·00372217006060·Insulin Pen Needle

    SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EMBOL-X INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN ZIMMER BIGLIANT/FLATOW HUMERAL STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSD·October 30, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    1.1 MM DRILL FOR 1.5 MM SCREW

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

    ACCOLADE DR SL MRI (Model L311)

    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