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

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    BIOPLEX VASCULITIS KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    CHIBA NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MDI GLIADIN A TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 13, 2024

    OSTAPEK VBR CAGE

    FDA Adverse Event
    Injury ·COLIGNE AG·Product code MQP·September 19, 2019

    D131 KIDS INFANT ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 20, 2026

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODUALTION·Product code GZB·April 18, 2013

    COULTER LH 750 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LOQ·April 28, 2011

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008

    D131 KIDS INFANT ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL.·Product code DTM·September 26, 2024

    D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·June 18, 2019

    D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code DTM·February 3, 2016

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022