BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    INSURGICAL SINGLE USE POWER EQUIPMENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOMOPHASE OCTIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015

    QUADRA H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 20, 2012

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·May 14, 2013

    UNK ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·September 10, 2014

    UNKNOWN DEPUY SROM 16MM SLEEVE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MRA·May 19, 2011

    ZIMMER AIR DERMATOME

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code GFD·September 7, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025