Medical Device Manufacturer · US , Mchenry , IL

Optical Micro Systems, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1981
21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Optical Micro Systems, Inc. Ophthalmic

19 devices
1-19 of 19
Cleared Jul 17, 1995
OMS SLIMLINE PHACO HANDPIECE
K950218 · HQC
Ophthalmic · 179d
Cleared Jul 11, 1995
DIPLOMAX
K946054 · HQC
Ophthalmic · 211d
Cleared Mar 14, 1994
OPHTHALMIC SURGICAL SYSTEM
K935223 · HQC
Ophthalmic · 133d
Cleared Feb 16, 1994
I/V POLE
K935226 · KYG
Ophthalmic · 107d
Cleared Jan 25, 1994
ELECTRIC I/V POLE OR EIVP2
K935003 · KYG
Ophthalmic · 98d
Cleared Feb 12, 1987
ASPIRATION REVERSAL CONTROL (ARC) MODULE
K870068 · HQE
Ophthalmic · 35d
Cleared Dec 19, 1985
O.M.S. ULTRA-PHACO
K844373 · HQC
Ophthalmic · 401d
Cleared Aug 21, 1985
OMS/GONVERS RETINAL PERFORATOR
K844448 · HNM
Ophthalmic · 278d
Cleared Jun 24, 1985
OMS SILICONE OIL INJECTOR
K844895 · LWL
Ophthalmic · 189d
Cleared Jan 22, 1985
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
K844715 · HQE
Ophthalmic · 56d
Cleared Dec 11, 1984
O.M.S. GUILLOTINE CUTTER
K844374 · HQE
Ophthalmic · 28d
Cleared Dec 11, 1984
OMS SCISSORS
K844510 · HQE
Ophthalmic · 21d
Cleared Jan 04, 1984
MACHEMER/TANO ROTATING
K833820 · HRJ
Ophthalmic · 63d
Cleared Feb 05, 1982
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
K813274 · HQE
Ophthalmic · 74d
Cleared Feb 05, 1982
OMS QUARTZ INFUSION CONTACT LENS
K820223 · HJI
Ophthalmic · 9d
Cleared Feb 04, 1982
OMS INFUSION-ASPIRATION HANDLE
K813500 · HQE
Ophthalmic · 52d
Cleared Jan 22, 1982
OMS INFUSION CANNULA ASSEMBLE
K813481 · HMX
Ophthalmic · 52d
Cleared Jan 22, 1982
OMS ANTERIOR CHAMBER INFUSION NEEDLE
K813483
Ophthalmic · 52d
Cleared Dec 31, 1981
EMERGENCY POWER PAC (EMPAC)
K813273 · HKP
Ophthalmic · 41d
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