25 results
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16ms
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Sources: EU EUDAMED, US FDA
S8-3 Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
C9-4v Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
X5-1 Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
S7-3t Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
D2cwc Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
FDA Enforcement
Class III
·Ongoing·Olympus Corporation of the Americas·May 31, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
FDA Enforcement
Class III
·Ongoing·Olympus Corporation of the Americas·May 31, 2023
L12-3 Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
L15-7IO TRANSDUCER Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
Transducer C10-3v Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
OMNI II TEE Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
Achieva 1.5T, Model No. 781178, 781196, 781296
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
7.5MHZ Endo Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
Philips C9-4 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
TRANSDUCER L12-5 Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
X3-1 Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
Philips L17-5 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
SCNHD LA L7-4 HDI Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
FDA Enforcement
Class III
·Ongoing·AMS Diagnostics, LLC·July 19, 2017
3D6-2 Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025