BEUDAMED
    52 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    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

    KYPHON XPANDER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·March 23, 2021

    KYPHON XPANDER¿ II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code HRX·August 26, 2025

    KYPHON XPANDER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·April 15, 2019

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·May 29, 2019

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code HRX·December 14, 2020

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·February 27, 2018

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·February 23, 2020

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·February 23, 2020

    KYPHON XPANDER¿ II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·May 11, 2021

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·June 23, 2021

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO·Product code HRX·July 8, 2020