BEUDAMED
    8 results · 36ms · Sources: EU EUDAMED, US FDA

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    Second Opinion® Pediatric

    FDA 510(k)
    FDA Class 2 ·Radiology

    Comfort Gown, Safewear Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Infrared Heat (Model: E0221)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYRINGE 50ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·June 18, 2024

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 11, 2014

    TRIAGE CARDIOPROFILER TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 29, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013

    12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·May 14, 2014