BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    VAPORTEMP HEAT AND MOISTURE EXCHANGER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Oneday Mini Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    RENEW RECEIVER KIT, 16-CHANNEL

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 4, 2015

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code LOX·January 18, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021