MYU
6 FDA 510(k) clearances · Product code
88 daysmedian time to decision
221 days90th percentile
6clearances measured
FDA profile
- Official device name
- Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5300
- Medical specialty
- Neurology
- Flags
- Implant
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (K033230) | Parallax Medical, Inc. | 2003-12-12 |
| BONE CEMENT RADIO-OPACIFIER (K032388) | Cardinalhealth | 2003-10-31 |
| VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (K024359) | Vista Scientific, LLC | 2003-08-08 |
| TRACERS BONE CEMENT OPACIFIER (K023445) | Parallax Medical, Inc. | 2003-03-11 |
| BIOTRACE, MODEL 1730 (K002063) | Bryan Corp. | 2000-08-10 |
| PARALLAX TRACER RADIOPAQUE PARTICLES (K991893) | Parallax Medical, Inc. | 1999-08-13 |
Track MYU automatically
Every clearance here is in the API, with alerts when new ones post.