BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707067191·LIGATURES MINI modules TRANSP/SILVER KIT

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123038·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 75mm

    Woo More Play Coconut Love Oil

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PARIEFIX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 1, 2014

    COOL PATH CATHETER 7F, 1304-CP-7-25-L

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL, IRVINE·Product code OAD·November 30, 2010

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·August 6, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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