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

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    T2 STRATOSPHERE Expandable Corpectomy System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T2 STRATOSPHERE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271425·

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145483·.20/.04/21mm ZenFlex CM NiTi FILE REFILL PACK

    MICRO TRAY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896019515·MICRO TRAY SINGLE LEVEL WITH SILICONE MAT GOLD

    KUBTEC XPERT 20

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNIMAX SPECIMEN RETRIEVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376521442·16 mm CORE ENDPLATE, BAN 18 x 35 mm 10°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376519272·12 mm CORE ENDPLATE, LAT 18 x 35 mm 10°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376520407·16 mm CORE ENDPLATE, LAT 18 x 35 mm 10°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376521084·12 mm CORE ENDPLATE, BAN 18 x 35 mm 10°

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code MQR·April 12, 2018

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 18, 2014

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011

    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

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code MQR·August 17, 2017

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FAD·March 12, 2015

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code MQR·March 15, 2018

    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