FDA applicant
Inovytech Medical Solutions, Ltd.
FDA records 1 decision for Inovytech Medical Solutions, Ltd. (Hod Hasharon Tel-Aviv, IL) in 2021: 1 510(k) clearance. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 1 predicate, 0 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 Inovytech Medical Solutions, 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 2021.
Planning a device like Inovytech Medical Solutions, 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