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

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    BOEHRINGER LABORATORIES SUCTION INTERMITTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209115402·

    Legacy™ GPS® Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307111290·

    HONEY ALGINATE DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    ROP Resorbable Hemostasis Material

    FDA 510(k)
    FDA Unclassified ·Unknown

    ETS LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 6, 2014

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·October 5, 2010

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 2, 2012

    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