BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    OMNI-TRAK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MENSINK-GOOSEN CATHETER

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

    FLEX-I-GRASP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVERA XT DR

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

    CAPSUREFIX NOVUS

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

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·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