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

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    GMK UNI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIATRON PICTUS 400

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·October 24, 2019

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2011

    AXIUM 3D DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·June 11, 2013

    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