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

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    Gamma3 System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LA PERSONAL SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013

    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