HRNClass II
Unit, Cryophthalmic, Ac-powered
Ophthalmic · 21 CFR 886.4170
MDR events3All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances10All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Injury2
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- PhakosJun 2, 2020
K200911 · MIRA Adapter
- PhakosMar 16, 2018
K180195 · Frigitronics adapter
- PhakosMay 3, 2017
K162756 · PHAKOS Disposable Retinal Cryo Probe
- Dutch Ophthalmic Research Center International BVJan 23, 2017
K160591 · D.O.R.C. Disposable Cryo Probe
- Keeler, Ltd.Dec 23, 2013
K131787 · CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
- Keeler Instruments, Inc.Dec 8, 2011
K112093 · CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
- Keeler Instruments, Inc.Nov 6, 2006
K062412 · CRYOMATIC
- Dutch Ophthalmic USA, Inc.Oct 22, 2001
K012821 · D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM