Panels › Ophthalmic › Product code HPS · Class 2
Unit, Cryophthalmic
Regulation 886.4170
0510(k)s in 12 months (11 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in HPS
| Company | 510(k)s | Recalls |
|---|---|---|
| Mira, Inc. | 1 | 3 |
| Keeler Instruments, Inc. | 2 | 0 |
| Beaver Visitec International, Inc. | 0 | 1 |
| Dutch Ophthalmic USA, Inc. | 1 | 0 |
| Edward Weck, Inc. | 1 | 0 |
| Intermedics, Inc. | 1 | 0 |
| Keeler Optical Products , Ltd. | 1 | 0 |
| Mono Research Laboratories | 1 | 0 |
| Spembly Medical , Ltd. | 1 | 0 |
| United Surgical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 30, 2020 | K202038 | CryoTreQ VitreQ BV, NL | HPS |
| Jul 18, 1994 | K940373 | OPHTHALMIC CRYO UNIT Dutch Ophthalmic USA, Inc. | HPS |
| Oct 19, 1992 | K923629 | OPHTHALMIC TRICHIASIS PROBE Mira, Inc. | HPS |
| Oct 11, 1990 | K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES Spembly Medical , Ltd., GB | HPS |
| Jan 29, 1988 | K874555 | KEELER ACU 22XT OPHTHALMIC CRYO UNIT Keeler Instruments, Inc. | HPS |
| Nov 13, 1987 | K873388 | KEELER CTU CRYO SYSTEM Keeler Instruments, Inc. | HPS |
| Feb 20, 1987 | K870195 | UNITED SURGICAL CORP. CRYOPTIC PLUS United Surgical Corp. | HPS |
| May 9, 1984 | K833747 | GALLIE CRYONUCLEATOR Mono Research Laboratories | HPS |
| Jul 21, 1980 | K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT Keeler Optical Products , Ltd. | HPS |
| Feb 12, 1979 | K790102 | MODEL 556-01 CRYOEXTRACTOR Intermedics, Inc. | HPS |
| Feb 12, 1979 | K781338 | BEAVER CATARACT CYROXTRACTOR Edward Weck, Inc. | HPS |
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