FDA applicant
Infinitum Eta, Ltd.
FDA records 3 decisions for Infinitum Eta, Ltd. (Petach Tikva, IL) from 2024 to 2025: 3 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 205 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 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 Infinitum Eta, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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