FDA applicant
3nt Medical, Ltd.
FDA records 4 decisions for 3nt Medical, Ltd. (Rosh Ha'Ayin, IL) from 2017 to 2021: 4 510(k) clearances. Most are in product codes EOB (Nasopharyngoscope (Flexible Or Rigid)) and LRC (Instrument, Ent Manual Surgical). Its devices cite 7 predicates, 2 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 3nt Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like 3nt Medical, 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