BEUDAMED
    13 results · 37ms · Sources: EU EUDAMED, US FDA

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    ISO-GARD MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Z-SERIES MODULAR TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLEASE700/900 SERIES VENTILATORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARMORLINK 7.5MM

    FDA Adverse Event
    Injury ·ORTHOPEDIATRICS, INC·Product code MBI·February 24, 2020

    SHIELDLOC 7.5MM

    FDA Adverse Event
    Injury ·ORTHOPEDIATRICS, INC·Product code MBI·December 2, 2019

    CAPTIFLEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·May 29, 2013

    CAPD DISCONNECT Y SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 17, 2011

    PROGRAMMING WAND

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 21, 2008

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 18, 2015

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 3, 2016

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 2, 2016

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021