BEUDAMED
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    MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Solitaire Platinum Revascularization Device, 6x40 mm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLATELIA ASPERGILLUS EIA, MODEL 62793

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ATLAS PTA BALLOON DILTATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·September 19, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013

    THOR MONOLITHIC SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code HXX·July 9, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Asheville) LLC·April 17, 2013