BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    XN CHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PLEURX LOCKABLE DRAINAGE LINE SET

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

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013

    COLLEAGUE PRE P1.7

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

    GORE HELEX SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, MEDICAL PRODUCTS DIVISION·Product code MLV·August 28, 2008

    BD KIESTRA IDENTIFA

    FDA Adverse Event
    Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024