BEUDAMED
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    THE BLUE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Ingenia

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838115743·Upgrade to the Elition X for our customers havi...

    Shear Stress Therapeutics SST 3000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FLOWMEDICA BENEPHIT INFUSION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    ARCHITECT HIV AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code MZF·April 30, 2014

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Injury ·MICRUS ENDOVASCULAR, LLC·Product code HCG·October 11, 2012

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 19, 2015

    Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021