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

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    CERULLO SUCTION REGULATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LOW FLUID ALARM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SonoSite iViz Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

    PREMILENE 2/0 (3) 75CM HR30 (M)

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAW·May 28, 2014

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·October 25, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012

    SAFIL UNDYED 5/0 (1) 70CM HR17 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·October 5, 2019

    SAFIL VIOLET 2/0 (3) 70CM DS24 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·June 4, 2019

    SAFIL VIOLET 5/0 (1) 45CM DS12 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·June 18, 2019

    SAFIL VIOLET 2/0 (3) 70CM FR26 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·February 17, 2020

    SAFIL UNDYED 4/0 (1,5) 70CM DS19 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·November 25, 2019

    SAFIL UNDYED 5/0 (1) 45CM DS12 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·October 3, 2019

    SAFIL UNDYED 4/0 (1,5) 70CM DS19 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·November 25, 2019

    SAFIL VIOLET 5/0 (1) 45CM DS12 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·June 18, 2019

    SAFIL VIOLET 2/0 (3) 70CM DS24 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·June 4, 2019

    SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·July 29, 2019

    SAFIL VIOLET 1 (4) 70CM HR40S (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAM·December 18, 2019

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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