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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Fujifilm Endoscope Models EC-600HL and EC-600LS

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

    ENDURAMESH

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HANDHELD ECG MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 9, 2024

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    WURAPA PIN DISTRACTOR

    FDA Adverse Event
    Malfunction ·G.HIPP AND SOHN·Product code LXH·April 25, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 14, 2011

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·October 10, 2014

    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 30, 2023