Medical Device Manufacturer · US , Mchenry , IL

Mentor O & O, Inc.

18 submissions · 18 cleared · Since 1982
18
Total
18
Cleared
0
Denied

Mentor O & O, Inc. — FDA 510(k) Submissions

Mentor O & O, Inc. has submitted 18 FDA 510(k) premarket notifications since 1982, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Chart, Visual Acuity, Unit, Phacofragmentation, Ophthalmoscope, Ac-powered, Instrument, Vitreous Aspiration And Cutting, Ac-powered, Apparatus, Cautery, Radiofrequency, Battery-powered . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
K955245 · HQC Unit, Phacofragmentation · Ophthalmic
Feb 1996 89d
MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
K934320 · HQR Apparatus, Cautery,... · Ophthalmic
Feb 1994 166d
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
K912904 · HQC Unit, Phacofragmentation · Ophthalmic
Jun 1992 345d
MENTOR HORIZON LOW VISION MAGNIFIER
K915340 · HJG System, Reading,... · Ophthalmic
Mar 1992 158d
MENTOR(R) SUR-E-TROL(R)
K910637 · FRN Pump, Infusion · General Hospital
May 1991 89d
MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
K911160 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 1991 48d
MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
K903878 · HQQ Apparatus, Cautery,... · Ophthalmic
Nov 1990 75d
MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
K895010 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Sep 1989 34d
SURG-E-TROL SYSTEM I AND SYSTEM II
K890622 · HQE Instrument, Vitreous... · Ophthalmic
May 1989 86d
MENTOR ANTERIOR SEGMENT VITRECTOR
K890595 · HKP Instrument, Vitreous... · Ophthalmic
Apr 1989 70d
MENTOR WET-FIELD*II COAGULATOR
K881001 · HQQ Apparatus, Cautery,... · Ophthalmic
May 1988 65d
MENTOR B-VAT(TM) II VIDEO TESTER
K875112 · HOX Chart, Visual Acuity · Ophthalmic
Mar 1988 84d
MENTOR BRIGHTNESS ACUITY TESTER
K853736 · HOX Chart, Visual Acuity · Ophthalmic
Nov 1985 56d
MAID MENTOR ASPIRATION/IRRIGATION DEVRO
K853382 · HQE Instrument, Vitreous... · Ophthalmic
Oct 1985 53d
CORNEAL LIGHT SHIELD
K850270 · HRM Microscope, Operating &... · General & Plastic Surgery
May 1985 128d
BINOCULAR INDIRECT OPHTHALMOSCOPE
K843304 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Nov 1984 90d
SHURE GRIP TYING FORCEPS
K844129 · HNR Forceps, Ophthalmic · Ophthalmic
Nov 1984 29d
MENTOR POTENTIAL ACUITY METER
K821932 · HOX Chart, Visual Acuity · Ophthalmic
Aug 1982 35d
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All18 Ophthalmic 15 General & Plastic Surgery 2 General Hospital 1