BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO API UNISCEPT 20GP

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Printed Lower ROC Pack for Herbst LR8 10mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015590·

    CALCIUM SULFATE PELLETS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MARKSMANN CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    ON-Q C-BLOC: 400ML, 2-14 ML/HR SAF + 5ML/30MIN

    FDA Adverse Event
    Malfunction ·I-FLOW LLC·Product code MEB·May 6, 2014

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 8, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·November 10, 2010

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·February 19, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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