BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    TITANIUM LOW PROFILE SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDPOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 6, 2013

    SECURA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·August 8, 2014

    5.5 HEALIX ADVANCE KNTLSS PK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MBI·July 24, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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