BEUDAMED
    11 results · 45ms · Sources: EU EUDAMED, US FDA

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    PercuNav Image Fusion and Interventional Navigation

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004873·MCK INLAY TRIAL (SIZE 6 X 8.5mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004866·MCK INLAY TRIAL (SIZE 6 X 7.5mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004859·MCK INLAY TRIAL (SIZE 6 X 6.5mm)

    AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

    FDA 510(k)
    FDA Class 2 ·Hematology

    IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL

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

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 21, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 14, 2013

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018