BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    TUBAL LUMEN SUPPORT

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

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123083·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 100mm

    SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIBRID® Unicompartmental Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNSPECIFIED SAFESET TRANSPAC SETS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 17, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Enforcement
    Class I ·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 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