11 results
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22ms
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Sources: EU EUDAMED, US FDA
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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 Enforcement
Class II
·Ongoing·THERAKOS DEVELOPMENT LIMITED·April 22, 2026
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
FDA Enforcement
Class II
·Ongoing·Cellex·September 22, 2021
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
FDA Enforcement
Class II
·Ongoing·Mallinckrodt Pharmaceuticals Ireland Ltd·February 16, 2022
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Enforcement
Class II
·Ongoing·Therakos, Inc.·November 17, 2021
The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis
FDA Enforcement
Class II
·Terminated·Therakos Inc·April 13, 2016
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
FDA Enforcement
Class II
·Terminated·Ellex iScience, Inc.·October 10, 2018
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
FDA Enforcement
Class II
·Terminated·Laserex Systems Inc.·April 13, 2016
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
FDA Enforcement
Class II
·Terminated·Laserex Systems Inc.·June 14, 2017
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
FDA Enforcement
Class II
·Terminated·Ellex iScience, Inc.·September 10, 2014
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
FDA Enforcement
Class II
·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023
Alinity hq Analyzer, REF: 09P68-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 28, 2024