BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    LOGIQ P10, LOGIQ P9, LOGIQ P8

    FDA 510(k)
    FDA Class 2 ·Radiology

    Avex CX

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205108050·Avex CX .018 LL4 D/HK (-12°T 2°A)

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113836·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 X...

    HAWKEYE™ Vertebral Body Replacement (VBR)

    FDA UDI
    Choice Spine, LP·00840996100984·VBR,SPACER,12X14X39,0 DEG

    CORE1 Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    HERO GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    RSP SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·August 2, 2011

    ALARIS PUMP MODULE ADMINSTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·August 14, 2014

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·July 3, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019