FDA applicant
Mazor Robotics, Ltd.
FDA records 13 decisions for Mazor Robotics, Ltd. (Caesarea, IL) from 2011 to 2025: 13 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and HAW (Neurological Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 14 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mazor Robotics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Mazor Robotics, 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) ReportOther applicant names beginning “Mazor”
FDA records each applicant name separately; these may or may not be the same firm.