5 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Change Healthcare Cardiology Hemodynamics software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
Change Healthcare Cardiology Hemo software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
McKesson Cardiology Hemo software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025