BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    VASCULAR CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARM UNIT, BATTERY OPERATED

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZODIC POLYAXIAL SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·October 1, 2010

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    UNKNOWN WOMEN'S HEALTH PRODUCT

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code UNK·December 14, 2012

    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