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

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    DentalJect

    FDA 510(k)
    FDA Unclassified ·Unknown

    Valleylab LS10 Generator

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

    Solevy Co. LLC Water-Based Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COULTER ACT DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·November 11, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 27, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 23, 2013

    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·March 27, 2024

    Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FON·February 19, 2024