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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.

    FDA Recall
    Open, Classified ·Nihon Kohden America Inc·Product code CCK·April 29, 2022

    Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each

    FDA Recall
    Open, Classified ·Nihon Kohden America Inc·Product code DQA·September 18, 2024

    Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box

    FDA Recall
    Open, Classified ·Nihon Kohden America Inc·Product code DQA·September 18, 2024

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Recall
    Open, Classified ·NOA Medical Industries Inc·Product code IKX·November 5, 2024

    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

    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022

    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

    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