BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    KVM ISOTONIC DILUENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    SPINAL CORD STIMULATION SYS SE-4

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSM3 HEMOXIMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    STOCKERT 3T HEATER-COOLER SYSTEM

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWC·June 12, 2014

    SCREW-IN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 27, 2010

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 21, 2012

    G7 NEUTRAL E1 LINER 32MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·April 14, 2022

    32MM MOD HEAD COCR +3MM NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDG·April 14, 2022

    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