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

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    NGM NIBP MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909116452·REVELATION DIAMOND 368-020M - 5 PACK

    FD TENS 2050 OR SLIDE TENS MODEL FD2050

    FDA 510(k)
    FDA Class 2 ·Neurology

    SKR 4000

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLEXOR RAABE GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·June 27, 2014

    UNKNOWN DEPUY ASR CUP

    FDA Adverse Event
    Injury ·DEPUY INT'L., LTD.·Product code KWA·November 29, 2010

    CD 1800 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·March 26, 2008

    SEE H10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018

    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