BEUDAMED
    8 results · 31ms · Sources: EU EUDAMED, US FDA

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    AIA-PACK E2 ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ORTHO SUMMIT SAMPLE HANDLER

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999

    POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROTURA COUCH SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNIVERSAL/GENERIC GENERIC

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code HWC·June 20, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013

    RUSCH FOLEY CATHETER, PEDIATRIC, 6FR, 100% SILICON

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code KOD·November 29, 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