BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    13-550,13-560 WESCOTT SCOSSORS (EYE)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209106004·KIT, MARITIME ODG

    Menicon Saline Rinse Solution

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CONTAIN X-RAY DETECTABLE LAP SPONGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 5, 2014

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·November 29, 2012

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·September 29, 2010

    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, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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