BEUDAMED
    10 results · 33ms · Sources: EU EUDAMED, US FDA

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    OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    STERIS CORPORATION·00724995152352·The Vis-U-All High Temperature Sterilization Tu...

    AxSOS 3 Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION 500D R&F X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 18, 2014

    TI SYNEX II CENTRAL BODY

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code MQP·October 20, 2010

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 14, 2012

    Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091

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

    Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091

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

    Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs 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