12 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·February 18, 2026
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
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Medline Item Numbers 10135910RH 10135936RH
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·October 8, 2025
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Ear Sensor, REF TS-E-D; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Wrap Sensor, REF TS-W-D; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023