ESF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3500
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2000: 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 |
|---|---|---|
| BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC (K891247) | Siemens Hearing Instruments, Inc. | 1989-03-29 |
| CERAVITAL CERAMIC EAR CANAL WALL PROSTH (K813224) | Xomed, Inc. | 1982-04-21 |
Track ESF automatically
Every clearance here is in the API, with alerts when new ones post.