BEUDAMED
    41 results · 23ms · Sources: EU EUDAMED, US FDA

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    ALIGNRT PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    ArgenZ ST 98x18 ML C4

    FDA UDI
    ARGEN CORPORATION, THE·D818123371·Dental porcelain/ceramic restoration kit

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970614·

    STAPHYLOCOCCUS QUICKFISH BC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COUDE/ OR TIEMANN

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

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·June 10, 2018

    KYPHON EXPRESS¿ II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code HRX·January 20, 2022

    KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L DE C.V.·Product code HRX·November 28, 2018

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·June 29, 2018

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HRX·June 29, 2018

    KYPHON® EXPRESS¿ INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·April 25, 2017

    OT VERIO TEST STRIPS

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 10, 2011

    KYPHON EXPRESS INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·October 17, 2017

    KYPHON EXPRESS INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code HRX·October 17, 2017

    KYPHON® EXPRESS¿ II INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·July 11, 2018

    KYPHON EXPRESS INFLATABLE BONE TAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·March 14, 2018