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American Optical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K950881PHACO TIPSeptember 6, 1995
K950880AOI UNIVERSAL ULTRASONIC HANDPIECEMay 26, 1995
K931358AORP4000 REUSABLE PAKFebruary 22, 1994
K931354P4000 PHACOEMULSIFIERFebruary 22, 1994
K931357AOD4000 DISPOSABLE PAKJanuary 25, 1994
K820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3April 1, 1982
K813430TISSUE PROCESSING CASSETTES & ACCESSDecember 29, 1981
K812965MODEL SC-6, FLEXIBLE SIAMOIDOSCOPENovember 2, 1981
K812051PHOTOLITE AOLITE TINTOMATIC LENSSeptember 8, 1981
K812063SR-1V DATA PRINTERAugust 18, 1981
K811535MODEL FUS-1, FLEXIBLE URETEROSCOPEJune 23, 1981
K811180ULTRAMATIC PROJECT-O-CHART OPHTH. PROJMay 15, 1981
K811181MODEL FBS-1, FLEXIBLE BRONCHOSCOPEMay 13, 1981
K802183SR-IV PROGRAMMED SUBJECTIVE REFRACTORApril 23, 1981
K802419AO NON-CONTACT II TONOMETERNovember 12, 1980
K802331AO FLEXIBLE LARYNGOSCOPE, #LS-7October 10, 1980
K801638A O CUSTOM II CHAIR AND STANDAugust 13, 1980
K801364AO STYLET LARYNGOSCOPE MODEL SLSJune 17, 1980
K801110PRESSURE MONITOR, MODEL 1131BMay 20, 1980
K800192DURALITE LENSMarch 12, 1980