BEUDAMED
    4 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    iLet Bionic Pancreas, REF: BB1001

    FDA Enforcement
    Class II ·Ongoing·Beta Bionics, Inc.·May 6, 2026

    NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)

    FDA Enforcement
    Class II ·Ongoing·NovaSignal Corp.·February 8, 2023

    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A

    FDA Enforcement
    Class II ·Ongoing·American Surgical Company, LLC·November 13, 2024

    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

    FDA Enforcement
    Class II ·Ongoing·Powers Medical Devices, LLC·December 16, 2015