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

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    Dental sensors NanoPix1, NanoPix2

    FDA 510(k)
    FDA Class 2 ·Dental

    Index Asurity Disposable Safety Scalpel

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630115025·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517072631·

    Image Quality Analyzer (IQA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Arietta 65

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 31, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

    EasyPoint Needle, 25G x 5/8", REF: 82091

    FDA Enforcement
    Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

    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 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