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

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    TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    STERIS CORPORATION·10724995152526·The Vis-U-All High Temperature Self Seal Steril...

    CENTAUR

    FDA UDI
    Stryker Corporation·07613327262308·SCREWDRIVER HOLDER

    DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    THERAPEUTIC LIMB MANIPULATOR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·June 19, 2014

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 27, 2010

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2012

    Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118

    FDA Recall
    Terminated ·Steris Corporation·Product code FRG·December 2, 2020

    Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·January 13, 2021

    Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·March 7, 2018