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

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    Noris Medical MBI Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH

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

    ENCOMPASS SOFTWARE PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 17, 2011

    ASR ACETABULAR CUPS 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·September 5, 2008

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 4, 2019

    ASAHI CONQUEST PRO 9-40

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

    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

    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

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023