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

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    SONGER CABLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODULAR HEAD BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NIPRO PUREFLUX-L HEMODIALYZER

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

    THERMAL SENSORY ANALYZER (TSA-II)

    FDA Adverse Event
    Injury ·MEDOC LTD., ADVANCED MEDICAL SURGERY MEDISCENSE USA·Product code LQW·December 26, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 18, 2013

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 9, 2014

    QSENSE CPM THERMAL SENSORY ANALYZER 2001

    FDA Adverse Event
    Malfunction ·MEDOC LTD, ADVANCED MEDICAL SYSTEM·Product code LQW·April 19, 2022

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021