MHC
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Needle, Interosseous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Medical specialty
- General Hospital
- Flags
- Implant
- Adverse events (MAUDE)
- 1993: 1 · 1994: 1 · 2007: 4
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 |
|---|---|---|
| BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (K223198) | Bard Access Systems | 2022-11-10 |
| BD Intraosseous Infusion System (K203193) | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | 2021-03-04 |
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Every clearance here is in the API, with alerts when new ones post.