BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    DANEK WRIST FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD Horizon™ Astute™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMFORT TWIN NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 13, 2018

    UNIFY CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 29, 2010

    FEMORAL CANAL TIP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS PUERTO RICO·Product code FQH·November 14, 2012

    CD HORIZON ASTUTE SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code NQP·April 16, 2021

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 17, 2018

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014