BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    DIGITRACE HOME VIDEO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    STABILITY HIP STEM WITH POROCOAT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    7F X 60CM DUAL PRO LINE CT

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code JCY·June 25, 2014

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NTE·February 11, 2013

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    G7 NEUTRAL ARCOMXL LNR 40MM I

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·August 20, 2018

    G7 OSSEOTI MULTIHOLE 66MM I

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 22, 2018

    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