BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    CLARUJUST

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

    CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROSETTA-LT/ROSETTA-RX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

    DURATA STS OPTIM PASSIVE FIXATION LEAD, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 3, 2013

    SENSIA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·May 18, 2011

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015