Product code LNR ยท Class 3
System, Photopheresis, Extracorporeal
0510(k)s in 12 months (0 all time)
1recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in LNR
| Company | 510(k)s | Recalls |
|---|---|---|
| Therakos Inc | 0 | 8 |
| Mallinckrodt Pharmaceuticals Ireland Ltd | 0 | 1 |
| THERAKOS DEVELOPMENT LIMITED | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2026 | THERAKOS DEVELOPMENT LIMITED Brand Name: Cellex Photopheresis System
Product Name: CELLEX Photopheresis Kit
Model/Catalog Number: CLXUSA
Software Version: Not Applicable
Product Description: THERAKOS Photopheresis or extracorpore Open, Classified |
LNR | None listed |
| Dec 10, 2021 | Mallinckrodt Pharmaceuticals Ireland Ltd THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA Open, Classified |
LNR | None listed |
| Oct 4, 2021 | Therakos, Inc. THERAKOS CELLEX Photopheresis Procedural Kit
PRODUCT CODE: CLXUSA Open, Classified |
LNR | None listed |
| Dec 21, 2015 | Therakos Inc 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 fraction Terminated |
LNR | None listed |
| Jan 11, 2012 | Therakos, Inc. 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 Terminated |
LNR | None listed |
| Aug 10, 2011 | Therakos, Inc. XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT
Single-use, disposable, closed system with sterile flu Terminated |
LNR | None listed |
| Jul 19, 2011 | Therakos Inc 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. Terminated |
LNR | None listed |
| Apr 28, 2011 | Therakos Inc Therakos UVAR XTS Procedural Kits
Is indicated for use in the ultraviolet-A (UVA) irradiation. Terminated |
LNR | None listed |
| May 26, 2010 | Therakos Inc Therakos CellEx Photopheresis System;
Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument; Terminated |
LNR | None listed |
| Sep 14, 2006 | Therakos Inc Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125) Terminated |
LNR | None listed |
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