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

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    0.9% SODIUM CHLORIDE FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·May 20, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 9, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

    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