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

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    XDCS-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122833·K-WIRE - DOUBLE TROCAR 0.8mm DIA x 75mm

    ORTHO SUMMIT SAMPLE HANDLER

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

    NUVASIVE NEUROVISION JJB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRILLIANCE 64

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·June 26, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·January 28, 2013

    PILLING CORONARY ARTERY SCISSORS, 120 DEGREE, 7"

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code LRW·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