BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    NEXXT SPINE NAVIGATION System

    FDA 510(k)
    FDA Class 2 ·Neurology

    EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OP SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1.6MM GUIDE WIRE 410MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·January 29, 2020

    1.6MM GUIDE WIRE 410MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·January 29, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 3, 2008

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·August 16, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025