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

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    GELPORT BLUNT TIP TROCAR SYSTEM

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

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606291·Mini-Mono-Brackets Roth 'S2' .018" 9° 400 Brack...

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 5, 2017

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 23, 2017

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 14, 2017

    FLEXTIME

    FDA 510(k)
    FDA Class 2 ·Dental

    SIMPLICITY SIMPLEX SOFT INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PLASTIPAK¿ SYRINGE LUER-LOK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 27, 2017

    COMPR 12MM IM HMRL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·April 5, 2013

    SHILEY

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code BTO·June 13, 2008

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 8, 2011

    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