3 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·February 18, 2026
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.
FDA Enforcement
Class I
·Ongoing·Biosense Webster, Inc.·March 12, 2025
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
FDA Enforcement
Class I
·Terminated·Biosense Webster, Inc.·September 5, 2018