FAA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Replacer, Urethral
- Device class
- Class III (high risk)
- Medical specialty
- Unknown
- Flags
- Implant
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COAXIAL BALLOON URETHRAL DILATOR (K833690) | American Edwards Laboratories | 1983-11-29 |
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Every clearance here is in the API, with alerts when new ones post.