BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEMORY STAPLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIOLINE touchECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONSULTA CRT-P

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014

    PEEK PUSHLOCK, 3.5MM X 19.5MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·October 7, 2010

    EXCELCARE BARIATRIC BED FRAME

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 30, 2012

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·June 13, 2018

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    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