BEUDAMED
    6 results · 14ms · 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 Status: Open, Classified ×

    Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

    FDA Recall
    Open, Classified ·Cellex·Product code QKP·March 1, 2021

    Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable

    FDA Recall
    Open, Classified ·Product code LNR·May 16, 2025

    THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

    FDA Recall
    Open, Classified ·Therakos, Inc.·Product code LNR·October 4, 2021

    THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

    FDA Recall
    Open, Classified ·Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin·Product code LNR·December 10, 2021

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    FDA Recall
    Open, Classified ·Ellex Medical Pty Ltd.·Product code HQF·March 16, 2023

    Alinity hq Analyzer, REF: 09P68-01

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·June 14, 2024