Olympus Medical Systems Corp. - FDA 510(k) Cleared Devices
Recent clearances: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS), Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR), EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
103
Total
103
Cleared
0
Denied
FDA 510(k) Regulatory Record - Olympus Medical Systems Corp. General Hospital ✕
4 devices
Cleared
Dec 08, 2020
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
General Hospital
85d
Cleared
Sep 01, 2020
Endoscope Reprocessor OER-Elite
General Hospital
53d
Cleared
Jul 09, 2019
ENDOSCOPE REPROCESSOR OER-Elite
General Hospital
88d
Cleared
Dec 20, 2012
ENDOSCOPE REPROCESSOR OER-MINI
General Hospital
318d