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

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    CANNABINOID URINE CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm

    General

    FDA UDI
    Seaspine Orthopedics Corporation·10889981087982·Coring Tip

    ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Hematology

    Halcyon, Ethos Radiotherapy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ESSURE

    FDA Adverse Event
    Malfunction ·CONCEPTUS, INC·Product code HHS·January 20, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-REDWOOD CITY·Product code MGB·December 17, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2014

    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