BEUDAMED
    3 results · 55ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Blue Belt Technologies MN·August 28, 2013

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code OLO·April 11, 2014

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code KKX·July 19, 2013