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

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    Visual-ICE Cryoablation System, Software Revision 1.3.1

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

    VENOFER PUMP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HORIZON ANGIO CATHLAB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLIBRI

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MOQ·October 6, 2014

    NC TENKU DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·June 3, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 2, 2011

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024