BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    FLEXXR* CPM SYSTEM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DAC-CEL DIAGNATAL RD 50

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Y-TYPE BACKCHECK MICROBORE EXTEN. SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COBAS 8000 C702 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 25, 2025

    UNICEL DXC 680I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·May 28, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 15, 2012

    QUATTRODE 3/4 LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 13, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018