BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    COBAS 6000 SERIES SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    939UDX URINE PATHOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMICAP/UNICAP RESURFACING PROSTHESIS

    FDA Adverse Event
    Other ·ARTHROSURFACE, INC.·Product code HSD·December 7, 2012

    ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 29, 2018

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·April 16, 2013

    SERIES 7000 STANDARD TIBIA

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·June 11, 2008

    RX HERCULINK ELITE STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code FGE·April 15, 2011

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022