FYI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Appliance, Facial Fracture, External
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3250
- Medical specialty
- General, Plastic Surgery
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OMEGA BIVALVE NASAL SPLINTS (K871073) | Omega Silicone, Inc. | 1987-05-11 |
| ETHICON EXTERNAL FIXATION WIRE (K821178) | ETHICON, Inc. | 1983-06-11 |
| STRAITH NASAL SPLINT (K801072) | Surgical Technology Laboratories, Inc. | 1980-06-17 |
| CONPHAR O.R. HEAD COVER-STERILE (K792106) | Conphar, Inc. | 1979-11-05 |
Track FYI automatically
Every clearance here is in the API, with alerts when new ones post.