BEUDAMED
    7 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Glidewell 3DP Denture Base Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    GUIDEZILLA GUIDE EXTENSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 22, 2008

    SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·August 17, 2011

    NEXGEN STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER·Product code JWH·July 3, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019