LNZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Changer, Tube, Endotracheal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 6 · 1993: 5 · 1994: 3 · 2010: 6
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 |
|---|---|---|
| ENDOTRACHEAL TUBE CHANGERS (K102127) | Instrumentation Industries, Inc. | 2010-08-27 |
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Every clearance here is in the API, with alerts when new ones post.