BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    ARTHREX CIRCULAR HARVESTING SAW

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

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122949·K-WIRE - SINGLE TROCAR 1.6mm DIA x 200mm

    SYSMEX XN SERIES

    FDA 510(k)
    FDA Class 2 ·Hematology

    ATRICURE DISSECTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CLEARVIEW UTERINE MANIPULATOR

    FDA Adverse Event
    Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 10, 2010

    6MM 30CM HEMASHIELD PLAT WDV

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code MAL·March 5, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 21, 2012

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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