Medical Device Manufacturer · US , Melville , NY

Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices

86 submissions · 86 cleared · Since 2004

Recent clearances: EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F), Gastrointestinal Videoscope Olympus GIF-2T1500, Disposable Distal Attachment D-201-13404

86

Total

86

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Medical Systems Corporation Ear, Nose, Throat ✕

9 devices

1-9 of 9

Cleared Aug 27, 2026

EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)

Ear, Nose, Throat · 202d

Cleared Mar 20, 2026

Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

Ear, Nose, Throat · 262d

Cleared Mar 03, 2025

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

Ear, Nose, Throat · 124d

Cleared Jun 15, 2023

EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus...

Ear, Nose, Throat · 266d

Cleared Nov 05, 2008

TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005

Ear, Nose, Throat · 49d

Cleared Aug 31, 2006

EVIS EXERA 180 SYSTEM

Ear, Nose, Throat · 113d

Cleared Jun 23, 2006

OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13

Ear, Nose, Throat · 143d

Cleared Sep 21, 2005

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

Ear, Nose, Throat · 15d

Cleared Feb 10, 2005

EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC

Ear, Nose, Throat · 10d