BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    O2 TEST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RIONET HEARING AID HB-69CI

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    CRISA

    FDA 510(k)
    FDA Class 1 ·Radiology

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FMG·June 2, 2014

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·October 26, 2012

    TIBIAL INSERT

    FDA Adverse Event
    Other ·EXACTECH INC.·Product code JWH·September 21, 2010

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024