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

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    SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

    FDA 510(k)
    FDA Class 2 ·Immunology

    Aequalis PerFORM+ Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 250 SERIES MATERNAL/FETAL MONITOR

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

    TPS HANDPIECE CORD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 5, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·June 15, 2015

    TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG

    FDA Adverse Event
    Injury ·TORNIER INC·Product code KWS·March 8, 2024

    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