Panels › Ophthalmic › Product code HNC · Class 1
Specula, Ophthalmic
Regulation 886.4350
0510(k)s in 12 months (11 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HNC
| Company | 510(k)s | Recalls |
|---|---|---|
| V. Mueller O.V. Baxter Healthcare Corp. | 3 | 0 |
| Douglas C. Mckee & Co. | 1 | 0 |
| Eyefix, Inc. | 1 | 0 |
| Howmedica Corp. | 1 | 0 |
| Keeler Instruments, Inc. | 1 | 0 |
| Laser Center Dev. Corp. | 1 | 0 |
| Myocure, Inc. | 1 | 0 |
| Sklar Instruments | 0 | 1 |
| Stephens Instruments | 1 | 0 |
| Visitec Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 1, 2002 | K022836 | STEPHENS DISPOSABLE SPECULUM Stephens Instruments | HNC |
| Jul 15, 1998 | K981235 | OCULOSTAT Laser Center Dev. Corp. | HNC |
| Dec 17, 1996 | K964289 | EYE FIXATION SPECULUM Eyefix, Inc. | HNC |
| Oct 31, 1986 | K863989 | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) Keeler Instruments, Inc. | HNC |
| Sep 25, 1986 | K863664 | OPHTHALMIC SURGICAL SPECULUM Myocure, Inc. | HNC |
| Oct 5, 1984 | K843196 | VISITEC EYE SPECULUM Visitec Co. | HNC |
| Jun 10, 1983 | K830430 | EYELID SPECULUM Douglas C. Mckee & Co. | HNC |
| Aug 27, 1980 | K801969 | ASNIS GUIDED SCREW SYSTEMS Howmedica Corp. | HNC |
| Nov 2, 1976 | K760849 | FELDSTEIN BLEPHAROSTOMY CLIP SQUARE V. Mueller O.V. Baxter Healthcare Corp. | HNC |
| Nov 2, 1976 | K760848 | FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU V. Mueller O.V. Baxter Healthcare Corp. | HNC |
| Nov 2, 1976 | K760847 | FELDSTEIN BLEPHAROPLASTY CLIP SHARP P V. Mueller O.V. Baxter Healthcare Corp. | HNC |
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