BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    DANA

    FDA 510(k)
    FDA Unclassified ·Unknown

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052016050·Tapered Burr 6,5

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1418650·14mm H x 18mm W x 65mm L x 0 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X14186580·14mm H x 18mm W x 65mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X141865120·14mm H x 18mm W x 65mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L141865120·14mm H x 18mm W x 65mm L XLIF Trial 12 degree L...

    ZOLL RESCUENET 12-LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLEURX LOCKABLE DRAINAGE LINE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·April 2, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    PLEURX

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·September 26, 2025

    PLEURX

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·June 2, 2025

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020