7 results
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13ms
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Sources: EU EUDAMED, US FDA
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories·October 30, 2013
Fetal Spiral Electrode, Model No. 9898 031 37631
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·May 8, 2019
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·October 31, 2018
BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·October 31, 2018
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·October 31, 2018
Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 2014
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
FDA Enforcement
Class II
·Terminated·FSC Laboratories, Inc·June 22, 2016