5 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FPA·July 6, 2005
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
FDA Enforcement
Class II
·Terminated·TomoTherapy Incorporated·December 17, 2014
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
FDA Enforcement
Class II
·Terminated·TomoTherapy Incorporated·August 27, 2014
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
FDA Enforcement
Class II
·Terminated·Accuray Incorporated·January 3, 2018
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016