BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    HOOK PROBE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TELL ME TAGS - NONPOWERED COMMUNICATION SYS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 12, 2010

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVY·December 10, 2012

    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