Houston, TX, US · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Class II | Neurology | 2 | 2025-11-05 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Class II | Neurology | 1 | 2025-11-21 |
| HBE | — | — | — | 1 | 2025-10-31 |
| HAW | — | — | — | 1 | 2025-07-09 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-03-21 | Class II | Ongoing | Z-2192-2025 | Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 | — | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time. |