BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    Shockwave Medical Intravascular Lithotripsy (IVL) System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COUGAR LS LATERAL CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 19, 2019

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 27, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 26, 2008

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·May 16, 2019

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017