BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    Gaudi Proximal Humerus Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023030·FPS 3.5/4.0mm Medial Column Plate Small

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077644·FPS 3.5/4.0 Medial Column Small Plate Sterile Q...

    MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI

    FDA 510(k)
    FDA Class 2 ·Neurology

    i-Rapha Solution

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERSATAP SUTURE ANCHOR

    FDA Adverse Event
    Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

    ANIGO-SEAL DEVICE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·November 20, 2008

    COLLEAGUE

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

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013

    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

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025