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

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    BEACH MOUTH MIRROR

    FDA 510(k)
    FDA Class 1 ·Dental

    U2 ACETABULAR CUP, PLASMA SPRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

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

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·November 8, 2024

    36MM COCR MOD HEAD +6MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 20, 2014

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·November 6, 2012

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 26, 2010

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012