BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    Revolution Maxima, Revolution Ace

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYOSURE ROD LENS SCOPE SEALS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ABL90 FLEX SERIES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

    EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 5, 2011

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2013

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015

    ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·January 12, 2011

    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