BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    COMFEEL BARRIER CREAM

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RENASYS GO NPWT DEVICE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW WOUND MANAGEMENT·Product code BTA·May 27, 2014

    AML HIGH OFFSET LG STAT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 15, 2012

    ADVISA DR MRI SURESCAN

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2015

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018