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 & Plastic Surgery ✕
14 devices
Cleared
Jul 01, 2026
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)
General & Plastic Surgery
196d
Cleared
Nov 12, 2025
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)
General & Plastic Surgery
196d
Cleared
Mar 09, 2022
4K UHD LCD Monitor OEV321UH
General & Plastic Surgery
58d
Cleared
Jul 17, 2020
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera...
General & Plastic Surgery
136d
Cleared
Jul 12, 2018
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm,...
General & Plastic Surgery
129d
Cleared
Apr 17, 2018
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm,...
General & Plastic Surgery
229d
Cleared
Dec 05, 2017
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4...
General & Plastic Surgery
96d
Cleared
Oct 04, 2017
Ultrasonic Generator
General & Plastic Surgery
28d
Cleared
Nov 22, 2016
Disposal Lens Cleaning Sheath
General & Plastic Surgery
327d
Cleared
Feb 26, 2016
THUNDERBEAT Open Fine Jaw
General & Plastic Surgery
242d
Cleared
May 19, 2014
THUNDERBEAT
General & Plastic Surgery
263d
Cleared
Aug 10, 2012
WIRELESS IMAGE TRANSMITTER UNIT
General & Plastic Surgery
193d
Cleared
Jun 29, 2012
SYSTEMS INTEGRATION
General & Plastic Surgery
21d
Cleared
Jan 20, 2012
SURGICAL TISSUE MANAGEMENT SYSTEM
General & Plastic Surgery
266d