BEUDAMED
    19 results · 35ms · Sources: EU EUDAMED, US FDA

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    ULCELOOCIN ORAL ULCER PATCH

    FDA 510(k)
    FDA Unclassified ·Unknown

    CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ERTAPENEM 10UG BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 8, 2021

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·October 30, 2014

    BD 5ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 1, 2020

    SYRINGE 5ML LL EURO 125 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 10, 2019

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2022

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 14, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·December 17, 2014

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 22, 2013

    U BY KOTEX CLICK TAMPONS

    FDA Adverse Event
    Malfunction ·AVENT S. DE R. L. DE C.V.·Product code HEB·April 15, 2011

    BD AUTOSHIELD PEN NEEDLE

    FDA Adverse Event
    Other ·BD MEDICAL - INFUSION THERAPY SYSTEMS·Product code FMI·July 3, 2008

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·April 27, 2020

    BD SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 13, 2021

    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