BEUDAMED
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    EMERALD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131164551·K130, BTE 13 SGR HHM

    AIM™FEMORAL NAIL

    FDA UDI
    Biomet Orthopedics, LLC·00887868003615·

    NITANIUM® SUPER ELASTIC ARCHWIRES

    FDA UDI
    Ortho Organizers, Inc.·00190707060251·.018 X .018 UPPER NITANIUM® SUPER ELASTIC OVAL ...

    ENDOSKELETON® TAS

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00191375032106·Perforated Inner Tray, Lower

    LIGHT-CURED ORTHODONTIC BAND CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Death ·COOK INC·Product code MIH·February 26, 2019

    ELECTRONIC GAS BLENDER

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025

    STOCKERT S3 GAS BLENDER

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014

    GLUCOMMANDER, G+

    FDA Adverse Event
    Malfunction ·GLYTEC, LLC·Product code NDC·April 30, 2013

    FORCETRIAD ENERGY PLATFORM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·September 19, 2014

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·August 5, 2008

    S3 GAS BLENDER SYSTEM

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

    S3 GAS BLENDER SYSTEM

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017

    S3 ELECTRONIC GAS BLENDER

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024

    SORIN S3 GAS BLENDER

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 13, 2022

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    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