8 devices · 6 companies · 2019 to 2026
Product code HAW: Neurological Stereotaxic Instrument
8 devices under product code HAW, 2019 to 2026, from 6 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 8 here), the regulation, and MAUDE report counts by product code.
Neurological Stereotaxic Instrument. 21 CFR 882.4560, Class II. MAUDE held 42,962 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Stealth AXiS Cranial clinical applicationK253379 · 510(k) | Medtronic Navigation, Inc. | Neurology | database entry | |
| ClearPoint SystemK243657 · 510(k) | ClearPoint Neuro, Inc. | Neurology | database entry | |
| FLASH EVD SystemK242480 · 510(k) | 7D Surgical ULC | Neurology | database entry | |
| ClearPoint SystemK233243 · 510(k) | ClearPoint Neuro Inc. | Neurology | database entry | |
| Alignment System Cranial, Alignment Software CraK223864 · 510(k) | Brainlab AG | Neurology | database entry | |
| Cranial Navigation, Navigation Software Cranial,K223288 · 510(k) | Brainlab AG | Neurology | database entry | |
| Brainlab Elements Trajectory PlanningK223552 · 510(k) | Brainlab AG | Neurology | database entry | |
| 7D Surgical System Cranial Biopsy and VentriculaK192945 · 510(k) | 7D Surgical Inc. | Neurology | database entry |
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