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

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    HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)

    FDA 510(k)
    FDA Class 2 ·Immunology

    HGM COMBINATION ND:YAG & SOLID STATE GREEN

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

    ADULT STAR, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HUT EXT DR FINAL ASSY-STANDARD

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM COMPANY·Product code IXR·May 27, 2014

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·December 19, 2012

    CIC PRO CLINICAL INFORMATION CENTER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·November 2, 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