BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    DENTANURSE

    FDA 510(k)
    FDA Class 2 ·Dental

    SUTTER HOSPITAL CPM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DEPUY ASR XL FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·June 25, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·January 3, 2013

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 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