BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    BOUFFANT CAP

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

    FUSE Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANTISERA TO HUMAN FREE KAPPA CHAINS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ARMADA 35 PTA CATHETER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code LIT·June 18, 2014

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·October 26, 2010

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 20, 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