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

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    AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTAURI/PEGASUS

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

    SRI T3 IMMOENZYMETRIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 12, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·November 29, 2010

    VIKING

    FDA Adverse Event
    Malfunction ·LIKO AB·Product code FSA·January 11, 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