BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221116772·3M™ Victory Series™ First Molar Bands, 953-284,...

    LEVEL ONE

    FDA UDI
    KLS-Martin L.P.·00888118118165·

    Synaptive ImageDrive Pro

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGBODY DT-600

    FDA 510(k)
    FDA Class 2 ·Neurology

    ATTAIN

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DYG·February 9, 2013

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 23, 2014

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 7, 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