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

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    Guarded Luer Connector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SHARPS TRANSPORT TUBE, MODEL 50035

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRINON Q & Q3 IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 17, 2013

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·July 23, 2011

    CNS-9700

    FDA Adverse Event
    Malfunction ·Product code MHX·September 10, 2014

    AMS INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·October 28, 2019

    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018