3 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025