Medical Device Manufacturer · JP , Hachiochi-Shi

Olympus Medical Systems Corp. - FDA 510(k) Cleared Devices

102 submissions · 102 cleared · Since 2012

Recent clearances: Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR), EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190), Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

Official Website

102

Total

102

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Medical Systems Corp. General & Plastic Surgery ✕

13 devices

1-12 of 13

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

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