BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD BBL™ Sensi-Disc™ Tobramycin - 10 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902315681·BD BBL™ Sensi-Disc™ Tobramycin 10 µg

    BICONITE SURFACE TREATMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    SUDO PATH

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    EXCELSIOR SL-10 PRE-SHAPED 45 MICROCATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION·Product code DQY·November 14, 2008

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Other ·DEXCOM, INC.·Product code MDS·August 16, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    HS WAVE 18CM OPEN SCHEARS

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 3, 2019

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, 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 Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

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

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022