BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    PERCUNAV SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NexxZr™ T / D-100-30-NT-B300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112972·

    KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 29, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·August 21, 2008

    INFANT BREATHING CIRCUIT FOR SLE 2000/2000HFO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 16, 2011

    Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DRE·June 9, 2021

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023