BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    SM Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    IVAS BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEWDEAL HALLU LOCK PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code PHX·December 22, 2025

    ESL PEEK SPACER

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code MQP·July 28, 2011

    2520274-2013-03444

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·June 21, 2013

    AUTOLUBE-III

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 2014

    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