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

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    LUNG DIFFUSION GAS MIXTURE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PREMIER ASP/CD RECHARGEABLE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SROM*STM ST,36+8L NK,20X15X165

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·January 22, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·December 10, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014

    CABLE CUTTER

    FDA Adverse Event
    Malfunction ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HXZ·January 31, 2018

    CABLE CUTTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXZ·November 23, 2021

    CABLE CUTTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXZ·September 29, 2022

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    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