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

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    Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PRECISION? MONTAGE? MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 23, 2025

    STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026

    FDA 510(k)
    FDA Class 2 ·Dental

    ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCRA CRT-P

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 8, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

    ASAHI CONQUEST PRO 9-40

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

    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

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023