DWH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Blade, Saw, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2007: 2 · 2008: 30 · 2009: 14 · 2010: 17 · 2012: 11 · 2013: 7
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 |
|---|---|---|
| CODMAN COLLINS RADIOPARENT STERNAL BLADES (K904352) | Codman & Shurtleff, Inc. | 1990-11-21 |
| HALL STERNUM SAW (K862474) | Hall Surgical, Division of Zimmer, Inc. | 1986-07-17 |
| MICRO-AIRE STERNUM SAW REPLACEMENT BLADES (K850483) | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 |
| CARDIOVASCULAR SAW BLADES (K830189) | Temp Medical Products, Inc. | 1983-03-24 |
Track DWH automatically
Every clearance here is in the API, with alerts when new ones post.