BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    HALO60 ABLATION CATHETER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 10, 2023

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 23, 2024

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·April 28, 2011

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021