BEUDAMED
    12 results · 13ms · Sources: EU EUDAMED, US FDA

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    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 Recall
    Open, Classified ·NovaSignal Corp.·Product code IYN·December 16, 2022

    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

    FDA Recall
    Open, Classified ·MICROVENTION INC.·Product code QCA·December 11, 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 Recall
    Open, Classified ·Powers Medical Devices, LLC·Product code HCC·October 1, 2015

    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 Recall
    Open, Classified ·American Surgical Company, LLC·Product code HBA·September 18, 2024

    REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code CKA·June 10, 2021

    Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

    Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

    Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

    REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code CKA·June 10, 2021

    REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code CKA·June 10, 2021

    Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

    FDA Recall
    Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

    REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code CKA·June 10, 2021