BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Synq Software Version 1.3

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Richard Wolf GmbH·04055207012031·CONNECTION CABLE reusable

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·September 30, 2013

    SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MirrorMe3D Modeling System

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 9, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 5, 2013

    BD ULTRA FINE PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 8, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 2, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·July 20, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025