BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    C-STAT/1000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DVX SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DTRAX Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 18, 2014

    THERAPY ABLATION CATHETER

    FDA Adverse Event
    Malfunction ·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·October 1, 2010

    LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 20, 2012

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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