BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Attain Assist CS Access Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COROX OTW-S 75-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code OJX·June 13, 2014

    HUBER NEEDLE SET 22GA 25MM

    FDA Adverse Event
    Malfunction ·LDKS OVERSAN·Product code FPA·October 16, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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