BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    AUDERE Lumbar Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131343581·G100, MINIRITE 312 2.4G C090 HHM

    HYDROCOIL EMBOLIC SYSTEM (HES)

    FDA 510(k)
    FDA Class 2 ·Neurology

    BALANCED KNEE SYSTEM HIGH FLEX PS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023

    CATH PKGD: WEDGE 5 FR 60 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DYG·July 13, 2011

    LIFESHIELD SYMBIQ SET WITH 2 CLAVES

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FRN·October 7, 2008

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·June 27, 2013

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023

    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