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

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    VESSEL DILATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517179791·VuePoint Screw, 4x16mm Multi Axial

    HAND CONTROLS, MODEL 3700 AND 3500 SERIES

    FDA 510(k)

    CONDOM (RUBBER) CONTRACEPTIVE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QUARTET

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013

    UNK DEPUY ENGAGE STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 19, 2010

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 1, 2014

    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 25, 2017

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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