HQA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Unit, Cryotherapy, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1995: 1 · 1996: 1 · 2001: 1 · 2002: 1 · 2019: 21 · 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
| Record | Firm | Date |
|---|---|---|
| SERIES 25 SLIMLINE CRYO PROBES (K854422) | Keeler Instruments, Inc. | 1985-12-30 |
| KEELER-COMPACT CRYO SYSTEM (K854411) | Keeler Instruments, Inc. | 1985-12-30 |
| ACU220 CRYO UNIT (K841294) | Keller Instruments, Inc. | 1984-08-15 |
| SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (K823835) | Keller Instruments, Inc. | 1983-01-17 |
Track HQA automatically
Every clearance here is in the API, with alerts when new ones post.