BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295116530·DELTA XTEND SCREW GUIDE PIN 1.2

    DePuy

    FDA UDI
    Provision·B504OM2307900040·

    DePuy

    FDA UDI
    Provision·B504OM2307900050·

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295116523·DELTA Xtend GLENOID DRILL GUIDE DIA 2.5 MM

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295116547·DELTA Xtend DRILL BIT Diameter 2,5 x 170 MM

    OSTEOMED ALVEOLAR DISTRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LYRIC2

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 12, 2010

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·October 24, 2014

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·August 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020