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

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    Probe Covers for Thermometers

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01

    FDA 510(k)
    FDA Class 2 ·Radiology

    PICASSO MIS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACHILLON SYSTEM

    FDA Adverse Event
    Malfunction ·NEWDEAL SAS·Product code HCF·October 15, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 20, 2013

    NDEHP 2CLV YSTE MACR

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·May 5, 2011

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014