BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    NIVP3 (WINDOWS VERSION OF NIVP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970570·anteriors; shade BL4; mould UCL

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665585981·MIS Fenestrated Screw, Ø10.5 x 70mm, Ø6.0mm Rod

    Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIO IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·June 2, 2014

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·February 20, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 25, 2011

    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