ESH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Medical specialty
- Ear, Nose, Throat
- 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 |
|---|---|---|
| AUDI-SIL EARMOLD MATERIAL (K771615) | Coe Laboratories, Inc. | 1977-08-30 |
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Every clearance here is in the API, with alerts when new ones post.