4 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 18, 2025
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
FDA Enforcement
Class III
·Ongoing·Sentinel CH SpA·July 14, 2021
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025