BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    SIL-MED WASTE FLUID DUMP BAG

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

    Carnation Ambulatory Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COROX PROMRI OTW 85-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code OJX·June 24, 2014

    INSERTER - 12MM

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code MAX·December 6, 2012

    PATIENT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM·Product code FNL·October 27, 2010

    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