Olympus Medical Systems Corp.
Olympus Medical Systems Corp. holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2026.
Top product codes for Olympus Medical Systems Corp.
Recent clearances by Olympus Medical Systems Corp.
1–100 of 104- K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB
- K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more
- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
- K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)
- K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700) +2 more
- K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more
- K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
- K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190) +4 more
- K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
- K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
- K250296 — Disposable Distal Attachment D-201 Series
- K250263 — Disposable Grasping Forceps FG-52D/FG-54D
- K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
- K240617 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K221690 — OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
- K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
- K221631 — Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
- K221638 — Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
- K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K220069 — 4K UHD LCD Monitor OEV321UH
- K212667 — Single Use Guide Sheath Kit-401, K-402
- K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
- K201300 — Airway Mobilescope
- K201758 — EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
- K200342 — Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
- K202661 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K203128 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
- K202646 — Visera Elite II Video System Center
- K201920 — Endoscope Reprocessor OER-Elite
- K201200 — Visera Elite II Video System Center
- K192793 — Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
- K200542 — Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
- K192103 — Thunderbeat Open Fine Jaw Type X Hand Instrument
- K192498 — Single Use Injector
- K200397 — Single Use Biopsy Forceps FB-456D
- K193026 — Visera Elite II Video System Center, Visera Elite II Endoeye 3D
- K192164 — Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
- K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K193039 — Single Use Balloon Dilator V (with knife)
- K190239 — Single Use Aspiration Needle
- K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
- K183416 — Rhino-Laryngo Videoscope Olympus ENF-VT3
- K183525 — EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
- K183419 — EVIS EXERA III Bronchovideoscope Olympus BF-XT190
- K190449 — Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
- K190293 — Single Use Cytology Brush BC-205D
- K183590 — Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
- K190969 — ENDOSCOPE REPROCESSOR OER-Elite
- K182408 — Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
- K183053 — Olympus Small Intestinal Capsule Endoscope System
- K182102 — RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
- K181451 — URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
- K173495 — Single Use Hot Biopsy Forceps FD-231
- K180668 — Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
- K181994 — Single Use Aspiration Needle NA-U201H
- K181240 — Rhino-Laryngo Fiberscope Olympus ENF-GP2
- K180575 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X
- K180449 — Single Use Aspiration Needle NA-U200H
- K172726 — EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
- K172610 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
- K172246 — OLYMPUS URF-V2/V2R
- K172298 — OLYMPUS URF-P6/P6R
- K173459 — Olympus Small Intestinal Capsule Endoscope System
- K172734 — Single Use Electrosurgical Snare SD-400
- K172618 — SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
- K170811 — Single Use Retrieval Nitinol Basket V
- K171158 — Single Use Electrosurgical knife
- K172817 — 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
- K171916 — Single Use Hot Biopsy Forceps FD-231
- K172691 — Ultrasonic Generator
- K163069 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K153773 — Disposal Lens Cleaning Sheath
- K160098 — Single Use Aspiration Needle NA-U401SX
- K160241 — Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
- K151743 — THUNDERBEAT Open Fine Jaw
- K153625 — Single Use Injector NM600/610
- K143153 — EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
- K151738 — Single Use Aspiration Needle NA-U200H
- K150142 — Single Use Balloon Dilator V (with Knife)
- K151011 — VISERA 4K UHD SYSTEM
- K143303 — Single Use Biliary Balloon Dilator
- K142680 — ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
- K132703 — THUNDERBEAT
- K134026 — ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
- K131780 — EVIS EXERA III VIDEO SYSTEM
- K123421 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K123601 — SINGLE USE REPOSITIONABLE CLIP
- K122505 — SINGLE USE PRELOADED SPHINCTEROTOME V
- K123365 — OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
- K130058 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
- K123704 — AUTOMATED ENDOSCOPE LEAK TESTER
- K121959 — EVIS EXERA III VIDEO SYSTEM
- K120357 — ENDOSCOPE REPROCESSOR OER-MINI
- K122831 — VIDEO SYSTEM CENTER
- K121564 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
- K113120 — CHF-Y0005
- K120278 — WIRELESS IMAGE TRANSMITTER UNIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.