BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    Sensor Medical Family of Vitrectomy Lenses and Products

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V

    REGIONAL OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TITAN DENTAL IMPLANT ATTACHMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·June 3, 2013

    RADIFOCUS GLIDEWIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 17, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 6, 2014

    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