BEUDAMED
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    Arcus Head Fixation Frame

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYSTEMS INTEGRATION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STRAUMANN MODIFIED DENTAL ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·DOLOMITE AB·Product code ITJ·October 22, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·June 26, 2013

    AUTOSONIX ULTRA SHEARS LONG

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code LFL·July 1, 2011

    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

    FDA Enforcement
    Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021