DXM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Densitometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1450
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1
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 |
|---|---|---|
| TAPE-A-TRACE (K791892) | Instromedix, Inc. | 1979-11-05 |
| CALIBRATOR, DYNAMIC (K781692) | Waters Assoc., Inc. | 1978-11-29 |
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Every clearance here is in the API, with alerts when new ones post.