BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PTI STERNAL CLOSURE WIRE SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CATALYS PRECISION LASER SYSTEM

    FDA Adverse Event
    Injury ·OPTIMEDICA CORPORATION·Product code OOE·January 10, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·November 17, 2010

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·July 6, 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