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

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    WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867364394·Bone Tap, 3.5 x 120mm

    LI WAH LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MAX-1 (EXERCISE ELECTROCARDIOGRAPH)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 20, 2014

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 5, 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

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014