31 results
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16ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260). For cochlear implant.
FDA Enforcement
Class III
·Terminated·Advanced Bionics, LLC·December 2, 2020
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.
FDA Enforcement
Class III
·Terminated·Advanced Bionics, LLC·December 2, 2020
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
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
FDA Enforcement
Class III
·Terminated·Arrow International Inc·February 4, 2015
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