BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    THE PERCEPTOR(TM) STAND ALONE TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FILMARRAY RP PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SurgicalAR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

    OPTI Q SVO2/CCO CATHETER

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code DQE·November 29, 2010

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·July 2, 2014

    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