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

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    SARNS 8000 MODULAR PERFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEON RUBBER SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NHS 2044P BODY AID, HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    GEMSTAR BULUSCORD (EACH)

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·May 16, 2014

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·January 15, 2013

    ECHELON

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS·Product code JDH·December 6, 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