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

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    APL CHOCOLATE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209117055·

    MEUROMETRICS MONITOR

    FDA 510(k)
    FDA Class 1 ·Neurology

    Galaxy UNYCO System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 6, 2014

    COR/TRI ANT STEM INSERT SHAFT

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code LXH·November 30, 2012

    PENUMBRA SYSTEM SEPARATOR 041

    FDA Adverse Event
    Other ·PENUMBRA, INC.·Product code NRY·September 29, 2010

    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 12, 2020

    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