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Sources: EU EUDAMED, US FDA
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Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use.
FDA Recall
Terminated
·Therakos, Inc.·Product code LNR·September 1, 2011
Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
FDA Recall
Terminated
·Therakos Inc·Product code LNR·March 29, 2010
Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
FDA Recall
Terminated
·Therakos Inc·Product code LNR·December 2, 2010
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
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 Recall
Terminated
·Therakos Inc·Product code LNR·December 21, 2015
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 Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
FDA Recall
Terminated
·Ellex USA·Product code HQF·June 13, 2007
Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex Innovative Imaging, Sacramento, CA 95827
FDA Recall
Terminated
·Ellex Inc.·Product code IYO·September 25, 2007
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 Recall
Terminated
·Ellex iScience, Inc.·Product code HMX·January 11, 2018
Ellex Super Q LQP3106 ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )
FDA Recall
Terminated
·Ellex USA·Product code HQF·June 13, 2007
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 Ultra Q LQP3106-U ophthalmic laser
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Ellex Solo LT5106-S ophthalmic laser (not sold in USA)
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
Ellex Tango LT5106-T ophthalmic laser (not sold in USA)
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011
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
Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
FDA Recall
Terminated
·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009
Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
FDA Recall
Terminated
·NRT Nordisk Rontgen Teknik A/S Birkegaardsvej 16 Hasselager Denmark·Product code JAA·May 1, 2009
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
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
FDA Recall
Terminated
·Ellex iScience, Inc.·Product code HMX·August 6, 2014