FZD
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Ear, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3590
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 1997: 1 · 2005: 2 · 2008: 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 |
|---|---|---|
| ePTFE-Coated Auricular Implant (K172389) | Implantech Associates, Inc. | 2018-07-18 |
| POREX(TM) EAR PROSTHESIS (K863939) | Porex Medical | 1986-10-24 |
| CANAL WALL PROSTHESIS (K844960) | Richards Medical Co., Inc. | 1985-02-26 |
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Every clearance here is in the API, with alerts when new ones post.