BEUDAMED
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    Transpara 1.7.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 1, 2024

    ALARIS SMARTSITE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026

    MODIFICATION TO M2376A DEVICELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRESSON ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 8, 2019

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE-SINGAPORE·Product code FRN·August 24, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 3, 2014

    4000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 1, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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