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

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    Filters Classification: Class Ii ×

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·December 26, 2012

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020