BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    TOP-RANK ADHESIVE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814600·Foerster Sponge Forceps, Curved, Smooth, 25cm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106120·Trial, 26 x 12mm, 8 Degree, Tapered, Straight

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481475968·

    VECTORVISION KNEE

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    9F PRUITT INAHARA OUTLYING SHUNT WITH T-PORT

    FDA Adverse Event
    Injury ·LEMAITRE VASCULAR·Product code MJN·April 12, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 27, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·July 1, 2008

    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 17, 2014

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013