BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    AUTOSTAT ANTI-THYROID MICROSSOMAL

    FDA 510(k)
    FDA Class 2 ·Immunology

    DURAPULSE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ALIGNRT PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·November 29, 2010

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·TRIVASCULAR, INC.·Product code MIH·July 9, 2014

    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