BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    APL TSA WITH 5% SHEEP BLOOD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Stainless Steel Wire

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746046889·WIRE SS UPPER 016 FORM I 50/PK

    DAVID PREGNANCY TEST (MIDSTREAM)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTH CORPORATION·Product code FRN·January 23, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·June 20, 2008

    FOUNDATION KNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·September 30, 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