5 results
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6ms
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Sources: EU EUDAMED, US FDA
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·January 18, 2017
Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 28, 2012
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 28, 2012
bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·November 28, 2012