PBL
1 FDA 510(k) clearances · Product code
FDA profile
- Adverse events (MAUDE)
- 2016: 23
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 |
|---|---|---|
| IMPELLA 2.5 PLUS CATHETER (K112892) | Abiomed, Inc. | 2012-09-06 |
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Every clearance here is in the API, with alerts when new ones post.