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

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    Fortrex 0.035 OTW PTA Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583025070·BL100 NR, PS MPL BLISS 100

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776166793·GROOVED DIRECTOR TONGUE TIE WITH PROBE

    PROTECTION PLUS EARLOOP PROCEDURE MASK

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

    VERTEX RAPID SIMPLIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    T7 DRIVER CANN AO

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code LXH·July 14, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·October 2, 2014

    URETEX SUP URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·March 15, 2013

    TRI CS INSERT TRI SZ1 11MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·June 21, 2011

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018