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

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    ARGYLE PVC FEEDING TUBE

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

    GETINGE 700HC-E SERIES STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCHED (DOUBLE PACKAGING)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·November 19, 2018

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 31, 2012

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·August 30, 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