FDA applicant
Saliwell, Ltd.
FDA records 4 decisions for Saliwell, Ltd. (Harutzim, IL) from 2017 to 2023: 4 510(k) clearances. Most are in product codes QTT (Over The Counter Electrical Salivary…) and LTF (Stimulator, Salivary System). Its devices cite 5 predicates, 4 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 Saliwell, Ltd.’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 2017.
Planning a device like Saliwell, Ltd.’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