BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIAL X COLLIMATOR MODEL A&B

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEVILBISS INTELLIPAP MODEL DV 5 SERIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·April 24, 2014

    NC QUANTUM APEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 4, 2012

    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNQ·July 27, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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