BXM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Stimulator, Nerve, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2004: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K013215) | Nuvasive, Inc. | 2001-10-16 |
| NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K002677) | Nuvasive, Inc. | 2000-11-13 |
| VER MED A10011 PNS DUAL ELEMENT ELECTRODE (K921498) | Vermont Medical, Inc. | 1993-06-09 |
| MODEL SKCK STERILE KNOB COVER KIT (K870662) | Life-Tech Intl., Inc. | 1987-10-28 |
Track BXM automatically
Every clearance here is in the API, with alerts when new ones post.