BEUDAMED
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    HISTONE EIA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    VARIAX

    FDA UDI
    Stryker GmbH·07613327125665·T8 Add-on Instrument Insert

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867524156·ECLIPSE SIZING PLATE, 53

    EASY MED TN-28 C

    FDA 510(k)
    FDA Class 2 ·Neurology

    MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE

    FDA 510(k)
    FDA Class 2 ·Radiology

    RETROFLEX 3 INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·February 2, 2013

    COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·December 9, 2010

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 17, 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