Company ยท US
Mentor O & O, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1996. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HOX | Chart, Visual Acuity | 3 |
| HLI | Ophthalmoscope, Ac-Powered | 2 |
| HQC | Unit, Phacofragmentation | 2 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 |
| HQQ | Apparatus, Cautery, Radiofrequency, Battery-Powered | 2 |
| FRN | Pump, Infusion | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HJG | System, Reading, Television, Closed-Circuit | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 |
| HNR | Forceps, Ophthalmic | 1 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 1996 | K955245 | MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM Mentor O & O, Inc. | HQC |
| Feb 16, 1994 | K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION Mentor O & O, Inc. | HQR |
| Jun 11, 1992 | K912904 | MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM Mentor O & O, Inc. | HQC |
| Mar 30, 1992 | K915340 | MENTOR HORIZON LOW VISION MAGNIFIER Mentor O & O, Inc. | HJG |
| May 13, 1991 | K910637 | MENTOR(R) SUR-E-TROL(R) Mentor O & O, Inc. | FRN |
| May 2, 1991 | K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 Mentor O & O, Inc. | GEI |
| Nov 5, 1990 | K903878 | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT Mentor O & O, Inc. | HQQ |
| Sep 11, 1989 | K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE Mentor O & O, Inc. | HLI |
| May 4, 1989 | K890622 | SURG-E-TROL SYSTEM I AND SYSTEM II Mentor O & O, Inc. | HQE |
| Apr 17, 1989 | K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR Mentor O & O, Inc. | HKP |
| May 13, 1988 | K881001 | MENTOR WET-FIELD*II COAGULATOR Mentor O & O, Inc. | HQQ |
| Mar 8, 1988 | K875112 | MENTOR B-VAT(TM) II VIDEO TESTER Mentor O & O, Inc. | HOX |
| Nov 1, 1985 | K853736 | MENTOR BRIGHTNESS ACUITY TESTER Mentor O & O, Inc. | HOX |
| Oct 4, 1985 | K853382 | MAID MENTOR ASPIRATION/IRRIGATION DEVRO Mentor O & O, Inc. | HQE |
| May 31, 1985 | K850270 | CORNEAL LIGHT SHIELD Mentor O & O, Inc. | HRM |
| Nov 21, 1984 | K844129 | SHURE GRIP TYING FORCEPS Mentor O & O, Inc. | HNR |
| Nov 21, 1984 | K843304 | BINOCULAR INDIRECT OPHTHALMOSCOPE Mentor O & O, Inc. | HLI |
| Aug 3, 1982 | K821932 | MENTOR POTENTIAL ACUITY METER Mentor O & O, Inc. | HOX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||