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

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    Xpert® Xpress CoV-2 plus

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Carbon

    FDA UDI
    Keystone Industries·H66842204400·FP3D Original Pink

    Penumbra System (Reperfusion Catheter RED 62)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OASYS-ORAL AIRWAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    UV-FLASH SOLUTION TRANSFER SET(SHORT)-JAPAN

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·August 15, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025