BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

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

    PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC

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

    OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONTURA MLB

    FDA Adverse Event
    Malfunction ·SENORX, INC.·Product code IWJ·October 31, 2008

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 19, 2011

    5.0MM FLEXIBLE SHAFT

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HTO·July 18, 2013

    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