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

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    DSL IGFBP-3 RIA (DSL 6700)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FREEDOM CONSTRAINED LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medical Diode Laser Systems

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA C.R.M., S.R.L.·Product code NVZ·November 18, 2010

    SM104 MSERIES W5TH WHLOBS3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 25, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 11, 2014

    ECLIPSE CAGE SCREW S, 30MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code QHQ·June 16, 2025

    ARTHREX ECLIPSE HUMERAL HEAD, 47/18

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code QHQ·June 16, 2025

    UNIVERSAL GLENOID - INLAY MEDIUM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code PHX·June 16, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;

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