BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Restoration Anatomic Shell

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMERICAN DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·June 8, 2020

    ALL IONIZING RADIATION PRODUCTS

    FDA Adverse Event
    Malfunction ·KONICA MINOLTA MEDICAL IMAGING, INC.·Product code MQB·June 22, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 5, 2014

    FLASH OSTIAL SYSTEM

    FDA Adverse Event
    Injury ·OSTIAL CORP.·Product code LOX·September 17, 2013

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011