Olympus Medical Systems Corp. - FDA 510(k) Cleared Devices
101
Total
101
Cleared
0
Denied
101 devices
Cleared
Feb 12, 2016
Single Use Injector NM600/610
Gastroenterology & Urology
56d
Cleared
Jan 15, 2016
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
Gastroenterology & Urology
438d
Cleared
Nov 20, 2015
Single Use Aspiration Needle NA-U200H
Gastroenterology & Urology
147d
Cleared
Oct 08, 2015
Single Use Balloon Dilator V (with Knife)
Gastroenterology & Urology
259d
Cleared
Oct 01, 2015
VISERA 4K UHD SYSTEM
Obstetrics & Gynecology
169d
Cleared
Feb 27, 2015
Single Use Biliary Balloon Dilator
Gastroenterology & Urology
101d
Cleared
Feb 08, 2015
ENDOCAPSULE SOFTWARE 10
Gastroenterology & Urology
142d
Cleared
May 19, 2014
THUNDERBEAT
General & Plastic Surgery
263d
Cleared
Mar 07, 2014
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
Gastroenterology & Urology
67d
Cleared
Aug 29, 2013
EVIS EXERA III VIDEO SYSTEM
Gastroenterology & Urology
73d
Cleared
Apr 29, 2013
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
Gastroenterology & Urology
174d
Cleared
Apr 29, 2013
SINGLE USE REPOSITIONABLE CLIP
Gastroenterology & Urology
159d
Cleared
Apr 11, 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
Gastroenterology & Urology
238d
Cleared
Mar 01, 2013
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
Obstetrics & Gynecology
121d
Cleared
Feb 22, 2013
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
Radiology
44d
Cleared
Feb 04, 2013
AUTOMATED ENDOSCOPE LEAK TESTER
Gastroenterology & Urology
63d
Cleared
Jan 10, 2013
EVIS EXERA III VIDEO SYSTEM
Ear, Nose, Throat
189d
Cleared
Dec 20, 2012
ENDOSCOPE REPROCESSOR OER-MINI
General Hospital
318d
Cleared
Dec 14, 2012
VIDEO SYSTEM CENTER
Gastroenterology & Urology
88d
Cleared
Oct 16, 2012
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Radiology
140d
Cleared
Sep 25, 2012
CHF-Y0005
Gastroenterology & Urology
340d
Cleared
Aug 10, 2012
WIRELESS IMAGE TRANSMITTER UNIT
General & Plastic Surgery
193d
Cleared
Jun 29, 2012
SYSTEMS INTEGRATION
General & Plastic Surgery
21d
Cleared
Apr 20, 2012
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
Obstetrics & Gynecology
333d
Cleared
Mar 20, 2012
V1 SYSTEM
Gastroenterology & Urology
272d
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