Medical Device Manufacturer · US , Mchenry , IL

American Optical Corp.

35 submissions · 35 cleared · Since 1976
35
Total
35
Cleared
0
Denied

American Optical Corp. — FDA 510(k) Submissions

American Optical Corp. has submitted 35 FDA 510(k) premarket notifications since 1976, of which 35 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, Phacofragmentation, Lens, Spectacle, Non-custom (prescription), Laryngoscope, Non-rigid, Refractometer, Ophthalmic, Detector And Alarm, Arrhythmia . Use the specialty filter in the sidebar to narrow results.

35 devices
1–25 of 35
PHACO TIP
K950881 · HQC Unit, Phacofragmentation · Ophthalmic
Sep 1995 191d
AOI UNIVERSAL ULTRASONIC HANDPIECE
K950880 · HQC Unit, Phacofragmentation · Ophthalmic
May 1995 88d
P4000 PHACOEMULSIFIER
K931354 · HQC Unit, Phacofragmentation · Ophthalmic
Feb 1994 342d
AORP4000 REUSABLE PAK
K931358 · HQC Unit, Phacofragmentation · Ophthalmic
Feb 1994 342d
AOD4000 DISPOSABLE PAK
K931357 · HQC Unit, Phacofragmentation · Ophthalmic
Jan 1994 314d
FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3
K820790 · FAM Sigmoidoscope And... · Gastroenterology & Urology
Apr 1982 9d
TISSUE PROCESSING CASSETTES & ACCESS
K813430 · IDL Microtome, Accessories · Pathology
Dec 1981 21d
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
K812965 · FAM Sigmoidoscope And... · Gastroenterology & Urology
Nov 1981 11d
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · HQG Lens, Spectacle,... · Ophthalmic
Sep 1981 49d
SR-1V DATA PRINTER
K812063 · HKO Refractometer, Ophthalmic · Ophthalmic
Aug 1981 28d
MODEL FUS-1, FLEXIBLE URETEROSCOPE
K811535 · FGB Ureteroscope And... · Gastroenterology & Urology
Jun 1981 22d
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ
K811180 · HOS Projector, Ophthalmic · Ophthalmic
May 1981 17d
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
K811181 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
May 1981 15d
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR
K802183 · HKO Refractometer, Ophthalmic · Ophthalmic
Apr 1981 226d
AO NON-CONTACT II TONOMETER
K802419 · HKX Tonometer, Ac-powered · Ophthalmic
Nov 1980 37d
AO FLEXIBLE LARYNGOSCOPE, #LS-7
K802331 · CAL Laryngoscope, Non-rigid · Anesthesiology
Oct 1980 17d
A O CUSTOM II CHAIR AND STAND
K801638 · HME Chair, Ophthalmic,... · Ophthalmic
Aug 1980 27d
AO STYLET LARYNGOSCOPE MODEL SLS
K801364 · CAL Laryngoscope, Non-rigid · Anesthesiology
Jun 1980 7d
PRESSURE MONITOR, MODEL 1131B
K801110 · DSK Computer, Blood-pressure · Cardiovascular
May 1980 8d
DURALITE LENS
K800192 · HPX Lens, Contact... · Ophthalmic
Mar 1980 43d
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
K792179 · FDF Colonoscope And... · Gastroenterology & Urology
Dec 1979 38d
SPECTRA CENTRAL PT MONITORING SYS
K792081 · DSI Detector And Alarm,... · Cardiovascular
Nov 1979 28d
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · HQG Lens, Spectacle,... · Ophthalmic
Oct 1979 54d
AO TEACHING ATTACHMENT, MODEL TA-1
K791635 · FEA Attachment, Teaching, For... · Gastroenterology & Urology
Sep 1979 34d
AO STYLET LARYNGOSCOPE, MODEL SLS-1
K791634 · CAL Laryngoscope, Non-rigid · Anesthesiology
Sep 1979 27d
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