BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    Kwart Retro-Inject Ureteral Stent

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

    K162309

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019

    ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BINAXNOW INFLUENZA A & B TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2011

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·June 3, 2013

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 16, 2008

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Death ·SOPHYSA·Product code GWM·November 18, 2024

    C-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 24, 2020

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FRN·September 6, 2019

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    dS Breast 16ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024