Calendar

Dec 5, 2025device pma267d agoMedtronic Minimed, Inc. — MiniMed 780G System (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

Dec 5, 2025device recall267d agoBeaver-Visitec International, Inc. device recall (Cls II)

BVI Leos Laser and Endoscopy System. Model Number: OME6000U. — Reason: Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable). — Status: Ongoing

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Dec 5, 2025device recall267d agoMeridian Bioscience Inc device recall (Cls II)Meridian Corp

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 — Reason: The affected lots show a decline in performance over time, which may lead to false-negative results. — Status: Ongoing

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Dec 5, 2025device recall267d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 — Reason: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect. — Status: Ongoing

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Dec 5, 2025device recall267d agoLimFlow, Inc. device recall (Cls II)

Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 — Reason: Incorrect expiration date — Status: Ongoing

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Dec 5, 2025grant267d agoALBANY MEDICAL COLLEGE — Interferons and eosinophils promote liver injury during Ehrlichia-induced shock

AI grant. $49,538. PI: Amber Bahr

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Dec 5, 2025grant267d agoVIRGINIA COMMONWEALTH UNIVERSITY — Implications of Epigenetic Regulation in Congenital Myotonic Dystrophy throug...Virginia Commonwealth University

HD grant. $45,988. PI: Julia Marie Hartman

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Dec 5, 2025grant267d agoTEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO — The Matricellular Protein Cyr61 Signaling Axis in Arterial Restenosis

HL grant. $241,702. PI: MEI-ZHEN CUI

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Week of Dec 1, 2025