BEUDAMED
    42 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 ×

    Polaris RF Ablation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780463450·McPherson Needle Holder 4-1/2", Smooth Jaws, St...

    KYPHON XPANDER II INFLATABLE BONE TAMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROLONG

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    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

    NA

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NUJ·June 17, 2013

    CAPTURE-CMV

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·July 28, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 25, 2008

    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