BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    PROPHYLACTIC (CONDOM)

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

    SAV-A-LIFE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    X-FLOW PROSTATECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·November 13, 2023

    CURRENT VR RF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 6, 2014

    SCREW LOCKING

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 3, 2012

    C-ARM

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 9, 2010

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·February 11, 2025