BEUDAMED
    46 results · 27ms · Sources: EU EUDAMED, US FDA

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    HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Oticon A/S·05707131158246·HIT PRO, BTE DBL

    Actiwatch

    FDA UDI
    Respironics, Inc.·00606959021440·Actiwatch Spectrum Plus

    Spark™ TruColor™

    FDA UDI
    METREX RESEARCH, LLC·00810210820059·Spark™ TruColor™ headlight system - Internation...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111010835·HI SD PERF TRAY 16.5X10X2.5

    CLEARJET

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

    MODIFICATION TO E-SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    Widex

    FDA UDI
    Widex A/S·05706069773255·Widex EVOKE E-PA (Lime Green S-440 ) RC coil

    KYPHOPAK TRAY

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·May 24, 2021

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·November 6, 2019

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·April 5, 2021

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·July 11, 2019

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·August 31, 2019

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·March 7, 2018

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 25, 2014

    UNICEL DXC 800 PRO INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·April 29, 2011

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·May 17, 2018

    1030489-2019-01511

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 15, 2023