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

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    PHACOEMULSIFICATION TIP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Capillus 272 Office Pro

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE

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

    S-ICD SYSTEM

    FDA Adverse Event
    Injury ·CAMERON HEALTH·Product code NVY·May 22, 2014

    MAXAN IMPLANTS

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code KWQ·October 1, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 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