Optical Micro Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 21
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K950218 | OMS SLIMLINE PHACO HANDPIECE | July 17, 1995 |
| K946054 | DIPLOMAX | July 11, 1995 |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | March 14, 1994 |
| K935226 | I/V POLE | February 16, 1994 |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | January 25, 1994 |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | February 12, 1987 |
| K844373 | O.M.S. ULTRA-PHACO | December 19, 1985 |
| K844448 | OMS/GONVERS RETINAL PERFORATOR | August 21, 1985 |
| K844895 | OMS SILICONE OIL INJECTOR | June 24, 1985 |
| K844467 | OMS CRYO | February 22, 1985 |
| K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY | January 22, 1985 |
| K844510 | OMS SCISSORS | December 11, 1984 |
| K844374 | O.M.S. GUILLOTINE CUTTER | December 11, 1984 |
| K833820 | MACHEMER/TANO ROTATING | January 4, 1984 |
| K813274 | BLOOD POOL & SUBVETINAL FLUID ASPIRATOR | February 5, 1982 |
| K820223 | OMS QUARTZ INFUSION CONTACT LENS | February 5, 1982 |
| K813500 | OMS INFUSION-ASPIRATION HANDLE | February 4, 1982 |
| K813483 | OMS ANTERIOR CHAMBER INFUSION NEEDLE | January 22, 1982 |
| K813481 | OMS INFUSION CANNULA ASSEMBLE | January 22, 1982 |
| K813545 | HYPOSERMIC NEEDLES | January 12, 1982 |