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

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    SOLITAIRE 2 REVASCULARIZATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORIA CLARIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    SCREW, UNKNOWN TYPE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code OYC·February 15, 2018

    OT VERIO IQ METER

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    SITTER SELECT

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·June 10, 2011

    PEN NEEDLE 32X4 ASIA XTW

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMI·March 7, 2019

    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