BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970735·anteriors; shade C2; mould IXL

    Powder-Free Clear Vinyl Patient Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DIALYZER, COIL, CD, LSA, 5M1765

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

    PLM A+ SPANISH DEVIC

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 29, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    ANI [ A&I ] GROUP TAIWAN·Product code IOR·February 20, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 25, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·April 28, 2016

    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