BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    Multistage Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SURESTEP ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·May 3, 2002

    VRESELECT CULTURE MEDIUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·November 3, 2014

    UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JLW·August 24, 2011

    PEAK PLASMA BLADE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY·Product code DWG·July 9, 2013

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021