BEUDAMED
    13 results · 32ms · Sources: EU EUDAMED, US FDA

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    Allura Xper R9

    FDA 510(k)
    FDA Class 2 ·Radiology

    CURIEPACS (DICOM PACS SOFTWARE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEPUY PINNACLE ALTRX ACETABULAR CUP LINER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 16, 2014

    GLUCOSE SENSOR FREESTYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code MDS·January 19, 2022

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

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

    GMK-HINGE EXTENSION STEM - FLUTED Ø 15 L 105

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 9, 2017

    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

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026