5 results
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15ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics Llc·July 4, 2012
Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.
FDA Enforcement
Class II
·Terminated·Estill Medical Technologies, Inc·October 29, 2014
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021