BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Neurology

    3.5 MM LCP DISTAL HUMERUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICRODOSE SI

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE SIZE 3/12 MM RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 17, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER SAS·Product code KWS·May 23, 2013

    KAPPA 900 DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·June 20, 2011

    N/A

    FDA Adverse Event
    Injury ·EL. EN. ELECTRONIC ENGINEERING SPA·Product code GEX·September 21, 2018

    DEKA SMARTXIDE2

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 22, 2021

    UNKNONW

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 9, 2018

    DEKA SMARTXIDE2

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 6, 2023

    UNKNOWN

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 7, 2022

    DEKA SMARTXIDE2

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 3, 2023

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015