Specula, Ophthalmic
FDA product code HNC · Class I (low risk) · 21 CFR 886.4350 · Ophthalmic
11510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022836 | Stephens Disposable SpeculumHNC · Traditional | Stephens Instruments | 11/01/2002SE |
| K981235 | OculostatHNC · Traditional | Laser Center Dev. Corp. | 07/15/1998SE |
| K964289 | Eye Fixation SpeculumHNC · Traditional | Eyefix, Inc. | 12/17/1996SE |
| K863989 | Thornton Titanium Speculum (Modified Barraquer)HNC · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K863664 | Ophthalmic Surgical SpeculumHNC · Traditional | Myocure, Inc. | 09/25/1986SE |
| K843196 | Visitec Eye SpeculumHNC · Traditional | Visitec Co. | 10/05/1984SE |
| K830430 | Eyelid SpeculumHNC · Traditional | Douglas C. Mckee & Co. | 06/10/1983SE |
| K801969 | Asnis Guided Screw SystemsHNC · Traditional | Howmedica Corp. | 08/27/1980SE |
| K760849 | Feldstein Blepharostomy Clip SquareHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760848 | Feldstein Blepharoplasty Clip RectanguHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760847 | Feldstein Blepharoplasty Clip Sharp PHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0949-2025 Class II | ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |