BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNTHES USS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD POSIFLUSH

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FOZ·November 22, 2021

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 22, 2016

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 10, 2013

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NTE·July 13, 2011

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DXT·September 11, 2008

    BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·October 21, 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