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

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    MobileLink Acetabular Cup System - inhouse coatings

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    360CAS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Respiratory Gating for Scanners v2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·December 19, 2017

    SL 1 INTRODUCER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011

    RESPONSE EP CATHETER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011

    TRANSSEPTAL NEEDLE, BRK SERIES

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 11, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 12, 2011

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·July 23, 2013

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 31, 2018

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024