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

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    Doppler FHR Detector (BF-500D+, BF-560)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BBX1, BBX2, BBX1MO, BBX1MC

    FDA 510(k)
    FDA Class 2 ·Dental

    SYSTEMP.LINK

    FDA 510(k)
    FDA Class 2 ·Dental

    IMP,TSV,3.7,13,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 22, 2021

    IMP,TSV,3.7,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·January 10, 2024

    IMP,TSV,3.7,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 22, 2021

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 19, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025