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

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    HYDRO PULSE MASSAGE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Gemini Titan Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CHARMCARE TABLETOP PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·October 16, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 20, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2010

    Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025