BEUDAMED
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    PROTECTAIDE CPR PROTECTION PACK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    2D Mercy TAPE & 3D Mercy TAPE

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

    BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017

    PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017

    BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 4, 2013

    TRIDENT ALUMINA INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MRA·December 22, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 17, 2014

    BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024

    BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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