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

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    EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenZ ST 98x16 ML C4

    FDA UDI
    ARGEN CORPORATION, THE·D818123370·Dental porcelain/ceramic restoration kit

    Logical G-Series

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215006068·

    Logical G-Series Acetabular Shell

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215052218·

    CHEETAH I.V.D.S., MODEL 2002P

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RT200

    FDA 510(k)
    FDA Class 2 ·Neurology

    VENTO Cup

    FDA UDI
    AMPLITUDE SAS·03701089514149·

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 26, 2014

    CAPSURE SENSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024