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

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    5MM DOUGLE EDGE RING CURETTE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    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

    CERTAS INLINE VLV ONLY

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF - MEDOS·Product code JXG·November 21, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 31, 2014

    PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 26, 2010

    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

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026