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Optical Micro Systems, Inc.

Mchenry, IL, US

Optical Micro Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 21 510(k) clearances for Optical Micro Systems, Inc. between 1981 and 1995. The busiest year on record is 1982, with 6. The most recent is 1995, with 2.

Clearances by year, as a table
510(k) clearance decisions for Optical Micro Systems, Inc., by decision year
YearClearances
19811
19826
19843
19855
19871
19943
19952
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K950218OMS SLIMLINE PHACO HANDPIECEHQCSubstantially Equivalent
K946054DIPLOMAXHQCSubstantially Equivalent
K935223OPHTHALMIC SURGICAL SYSTEMHQCSubstantially Equivalent
K935226I/V POLEKYGSubstantially Equivalent
K935003ELECTRIC I/V POLE OR EIVP2KYGSubstantially Equivalent
K870068ASPIRATION REVERSAL CONTROL (ARC) MODULEHQESubstantially Equivalent
K844373O.M.S. ULTRA-PHACOHQCSubstantially Equivalent
K844448OMS/GONVERS RETINAL PERFORATORHNMSubstantially Equivalent
K844895OMS SILICONE OIL INJECTORLWLSubstantially Equivalent
K844467OMS CRYOSubstantially Equivalent
K844715VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SYHQESubstantially Equivalent
K844510OMS SCISSORSHQESubstantially Equivalent
K844374O.M.S. GUILLOTINE CUTTERHQESubstantially Equivalent
K833820MACHEMER/TANO ROTATINGHRJSubstantially Equivalent
K820223OMS QUARTZ INFUSION CONTACT LENSHJISubstantially Equivalent
K813274BLOOD POOL & SUBVETINAL FLUID ASPIRATORHQESubstantially Equivalent
K813500OMS INFUSION-ASPIRATION HANDLEHQESubstantially Equivalent
K813483OMS ANTERIOR CHAMBER INFUSION NEEDLESubstantially Equivalent
K813481OMS INFUSION CANNULA ASSEMBLEHMXSubstantially Equivalent
K813545HYPOSERMIC NEEDLESFMISubstantially Equivalent
K813273EMERGENCY POWER PAC (EMPAC)HKPSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain