BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VIASPAN

    FDA Adverse Event
    Other ·FRESENIUS KABI AUSTRIA GMBH·Product code KDL·March 26, 2012

    LONG TERM RECORDER RAG 1200

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    COULTER CK-MB ISOENZYME REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TEARDROP HANDLE, AO COUPLING IMPLANT EXTRACTION SE

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 11, 2013

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·July 16, 2014

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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