Panels › Ophthalmic › Product code HRN · Class 2
Unit, Cryophthalmic, Ac-Powered
Regulation 886.4170
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Keeler Instruments, Inc. | 3 | 0 |
| Phakos | 3 | 0 |
| Dutch Ophthalmic USA, Inc. | 1 | 0 |
| Dutch Ophthalmic Research Center International BV | 1 | 0 |
| Keeler, Ltd. | 1 | 0 |
| Terumo Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2020 | K200911 | MIRA Adapter Phakos, FR | HRN |
| Mar 16, 2018 | K180195 | Frigitronics adapter Phakos, FR | HRN |
| May 3, 2017 | K162756 | PHAKOS Disposable Retinal Cryo Probe Phakos, FR | HRN |
| Jan 23, 2017 | K160591 | D.O.R.C. Disposable Cryo Probe Dutch Ophthalmic Research Center International BV, NL | HRN |
| Dec 23, 2013 | K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES Keeler, Ltd. | HRN |
| Dec 8, 2011 | K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER Keeler Instruments, Inc. | HRN |
| Nov 6, 2006 | K062412 | CRYOMATIC Keeler Instruments, Inc. | HRN |
| Oct 22, 2001 | K012821 | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM Dutch Ophthalmic USA, Inc. | HRN |
| Dec 21, 1999 | K992954 | KEELER CRYO MASTER & PROBES Keeler Instruments, Inc. | HRN |
| Jan 8, 1983 | K823768 | CLIRANS TE08 HOLLOW FIBER DIALYZER Terumo Medical Corp. | HRN |
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