BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Comprehensive Humeral Fracture Positioning Sleeves

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

    PROFEMUR RADEL TRIAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LXH·November 6, 2007

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

    Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021