BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    REMI Remote EEG Monitoring System

    FDA 510(k)
    FDA Class 2 ·Neurology

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SOLUTIS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·May 3, 2018

    25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·November 3, 2016

    QT SCANNER 2000 MODEL A

    FDA Adverse Event
    Injury ·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·July 20, 2011

    530G INSULIN PUMP

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

    ALTRX +4 NEUT 36IDX52OD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 17, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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