FDA applicant
Bioprotect, Ltd.
FDA records 1 decision for Bioprotect, Ltd. (Tzur Yigal, IL) in 2023: 1 510(k) clearance. All are in product code OVB (Hydrogel Spacer). 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 Bioprotect, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2023high 1 (2023) · low 0 (2024)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Bioprotect, 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