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

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    TAYLOR LONG TERM MONITORING ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Injectable Root Canal Bioceramic Sealer (i-MTA SP)

    FDA 510(k)
    FDA Class 2 ·Dental

    MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 30, 2010

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code FSA·July 17, 2014

    SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FQH·December 21, 2012

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025