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

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    PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909107552·REVELATION DIAMOND 859-016C - 5 PACK

    Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2017

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 11, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 22, 2010

    SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·July 2, 2014

    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