HRQ
15 FDA 510(k) clearances · Product code
33 daysmedian time to decision
67 days90th percentile
15clearances measured
FDA profile
- Official device name
- Hemostat
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1994: 2 · 1997: 4 · 1998: 1 · 2002: 1 · 2019: 14 · 2021: 15
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
Track HRQ automatically
Every clearance here is in the API, with alerts when new ones post.