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

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    URIC ACID (LIQUID) REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970560·anteriors; shade BL4; mould BOS

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665585967·MIS Fenestrated Screw, Ø10.5 x 60mm, Ø6.0mm Rod

    SAGE Vitrification Kit and SAGE Vitrification Warming Kit

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

    LRTM SURGICAL MESH

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

    MESH, SURGICAL

    FDA Adverse Event
    Injury ·W. L. GORE AND ASSOCIATES, INC.·Product code FTM·August 12, 2023

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·June 29, 2017

    LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 10, 2022

    8 MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·February 20, 2013

    M2A 38MM MOD HD -3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 31, 2014

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code JJE·January 25, 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