DXL
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Injector, Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1660
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 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 |
|---|---|---|
| TUBE, HEAVY GLASS WALL INJECTION (K760500) | Unimetrics Corp. | 1976-09-03 |
| SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT (K760448) | Instrumentation Laboratory CO | 1976-08-27 |
| TRAY, ICED INJECTABLE (26420) (K760066) | Instrumentation Laboratory CO | 1976-07-21 |
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Every clearance here is in the API, with alerts when new ones post.