FDA applicant
Smd Manufacturing, LLC
FDA records 2 decisions for Smd Manufacturing, LLC (Salt Lake City, UT) from 2018 to 2023: 2 510(k) clearances. All are in product code MNS (Ventilator, Continuous, Non-Life-Supporting). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smd Manufacturing, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Smd Manufacturing, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report