BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    ALT (GPT) - ALANINE AMINOTRANSFERASE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837016784·

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111109·INSTRUMENT CASE DOUBLE ALUMINUM

    TRUTEK SELECT MODEL TT-1001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAGNETOM SKYRA

    FDA 510(k)
    FDA Class 2 ·Radiology

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·January 22, 2013

    VIRTUOSO VR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·December 14, 2010

    OPTISENSE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 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