BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    EVOS Wrist Fracture Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    SENTINEL PLASMAPROTEINS CAL 3X

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

    LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2018

    AL-III-DISS W/20' HOSE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEI·June 21, 2013

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·July 6, 2011

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 25, 2008

    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