HBM
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Headrest, Neurosurgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 882.4440
- Medical specialty
- Neurology
- Adverse events (MAUDE)
- 1997: 4 · 1998: 3 · 1999: 1 · 2000: 2 · 2003: 3 · 2020: 17
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 |
|---|---|---|
| SWIVEL HORSESHOE HEADREST (K911918) | Codman & Shurtleff, Inc. | 1991-07-17 |
| CODMAN PEDIATRIC HORSESHOE HEADREST (K911917) | Codman & Shurtleff, Inc. | 1991-07-17 |
| SURGICAL HEAD SUPPORT (K822169) | Kelleher Corp. | 1982-08-20 |
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