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

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    VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209104147·KIT, TORK

    ICS Impulse

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPYSCOPE ACCESS AND DELIVERY CATHETER

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

    VISISTAT 35W 6/BOX

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GAG·March 25, 2014

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 29, 2012

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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