FDA applicant
Augmedics, Ltd.
FDA records 7 decisions for Augmedics, Ltd. (Yokneam Illit, IL) from 2019 to 2026: 7 510(k) clearances. All are in product code SBF (Orthopedic Augmented Reality). Since 2016 its 510(k)s took a median of 109 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Augmedics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Augmedics, 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