9 results
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29ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
FDA Enforcement
Class II
·Terminated·Caption Health·July 28, 2021
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack
FDA Enforcement
Class I
·Ongoing·Windstone Medical Packaging, Inc.·November 10, 2021
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Enforcement
Class II
·Terminated·Volcano Corp·July 15, 2015
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 17, 2024
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 17, 2024
GE Healthcare Vivid S70N, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S60N, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S60, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023
GE Healthcare Vivid S70, ultrasound device
FDA Enforcement
Class II
·Ongoing·GE Vingmed Ultrasound As·July 19, 2023