Company ยท US
Marco Ophthalmic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1994. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HLM | Instrument, Measuring, Lens, Ac-Powered | 2 |
| GEX | Powered Laser Surgical Instrument | 1 |
| HJB | Instrument, Measuring, Corneal Radius | 1 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 |
| HLF | Device, Measuring, Lens Radius, Ophthalmic | 1 |
| HME | Chair, Ophthalmic, Ac-Powered | 1 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 1 |
| HOO | Perimeter, Ac-Powered | 1 |
| HOS | Projector, Ophthalmic | 1 |
| HPC | Set, Lens, Trial, Ophthalmic | 1 |
| HPT | Perimeter, Automatic, Ac-Powered | 1 |
| HRJ | Table, Instrument, Powered, Ophthalmic | 1 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 1994 | K943234 | MS-30 AUTOMATIC PERIMETER Marco Ophthalmic, Inc. | HPT |
| Aug 9, 1993 | K930444 | MARCO STANDARD KERATOMETERS Marco Ophthalmic, Inc. | HJB |
| Aug 9, 1993 | K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS Marco Ophthalmic, Inc. | HKI |
| Aug 9, 1993 | K930438 | MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS Marco Ophthalmic, Inc. | HJO |
| Aug 9, 1993 | K930437 | MARCO STANDARD RADIUSGAUGES Marco Ophthalmic, Inc. | HLF |
| Jul 22, 1993 | K930439 | MARCO SURGISCOPE OPERATION MICROSCOPES Marco Ophthalmic, Inc. | HRM |
| Jul 6, 1993 | K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR Marco Ophthalmic, Inc. | HME |
| Jul 6, 1993 | K930447 | MARCO H AND TS-1 INSTRUMENT TABLES Marco Ophthalmic, Inc. | HRJ |
| Jul 6, 1993 | K930446 | MARCO TRIAL SETS Marco Ophthalmic, Inc. | HPC |
| Jul 6, 1993 | K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE Marco Ophthalmic, Inc. | HOS |
| Jul 6, 1993 | K930441 | MARCO STANDARD LENSMETERS 101,201 Marco Ophthalmic, Inc. | HLM |
| Jul 6, 1993 | K930440 | MARCO INTERNATIONAL STAND Marco Ophthalmic, Inc. | HMF |
| Jun 21, 1993 | K930448 | MARCO PROJECTION PERIMETER Marco Ophthalmic, Inc. | HOO |
| Jun 21, 1993 | K930445 | MARCO LM-770 DIGITAL PROJECTION LENSMETER Marco Ophthalmic, Inc. | HLM |
| Jul 2, 1992 | K921320 | ELIOS DIODE OPHTHALMIC LASER Marco Ophthalmic, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||