BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50

    CHROLOY SOLDER

    FDA 510(k)
    FDA Class 2 ·Dental

    SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VISCOJECT 1.8 DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code MSS·August 4, 2011

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·October 17, 2014

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 2, 2013

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·December 5, 2018

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·April 28, 2020

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·May 18, 2020

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·May 18, 2020

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·January 7, 2020

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·November 11, 2019

    EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·June 3, 2019

    EXCOR BLOOD PUMP PU VALVES,30 ML IN/OUT Ø9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·May 24, 2019

    SOLITAIRE FR

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·February 26, 2021

    SOLITAIRE FR

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·February 26, 2021

    ATTUNE RP TIB BASE SZ 6 CEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code NJL·March 10, 2021

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021