3 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·October 14, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022