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

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    THE WOOG ORATEST

    FDA 510(k)
    FDA Class 1 ·Dental

    OXYGEN CONCENTRATOR, MODEL BX-5000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    O.M.S. GUILLOTINE CUTTER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    THUNDERBEAT 5MM, 35MM, FRONT -ACTUATED GRIP

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code GEI·April 18, 2014

    8MM MCS TIP COVER ACCESSORY

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 19, 2010

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·December 14, 2012

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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