BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    FACEMASTER FACIAL TONING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    TGL FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·September 17, 2019

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 8, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·March 24, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·April 28, 2008

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code DQX·September 1, 2023

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024