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Olympus Medical Systems Corp.

103 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) (K254056)Olympus Medical Systems Corp.2026-07-01
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K260580)Olympus Medical Systems Corp.2026-05-21
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) (K252341)Olympus Medical Systems Corp.2026-04-23
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (K251807)Olympus Medical Systems Corp.2026-03-06
Single Use Distal Cover MAJ-2315 (MAJ-2315) (K253646)Olympus Medical Systems Corp.2026-02-22
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (K251336)Olympus Medical Systems Corp.2025-11-12
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (K252646)Olympus Medical Systems Corp.2025-10-24
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (K250945)Olympus Medical Systems Corp.2025-10-17
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (K251867)Olympus Medical Systems Corp.2025-09-19
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) (K250862)Olympus Medical Systems Corp.2025-06-23
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (K250701)Olympus Medical Systems Corp.2025-06-05
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (K250573)Olympus Medical Systems Corp.2025-05-27
Disposable Distal Attachment D-201 Series (K250296)Olympus Medical Systems Corp.2025-05-01
Disposable Grasping Forceps FG-52D/FG-54D (K250263)Olympus Medical Systems Corp.2025-03-31
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (K243807)Olympus Medical Systems Corp.2025-03-18
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K240617)Olympus Medical Systems Corp.2024-06-03
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) (K221690)Olympus Medical Systems Corp.2022-12-29
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (K221660)Olympus Medical Systems Corp.2022-12-28
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V (K221631)Olympus Medical Systems Corp.2022-09-26
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 (K221638)Olympus Medical Systems Corp.2022-09-19
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K220587)Olympus Medical Systems Corp.2022-05-11
4K UHD LCD Monitor OEV321UH (K220069)Olympus Medical Systems Corp.2022-03-09
Single Use Guide Sheath Kit-401, K-402 (K212667)Olympus Medical Systems Corp.2021-09-22
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (K201832)Olympus Medical Systems Corp.2021-09-17
Airway Mobilescope (K201300)Olympus Medical Systems Corp.2021-01-26
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 (K201758)Olympus Medical Systems Corp.2021-01-21
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 (K200342)Olympus Medical Systems Corp.2020-12-17
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K202661)Olympus Medical Systems Corp.2020-12-08
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS (K203128)Olympus Medical Systems Corp.2020-11-09
Visera Elite II Video System Center (K202646)Olympus Medical Systems Corp.2020-10-29
Endoscope Reprocessor OER-Elite (K201920)Olympus Medical Systems Corp.2020-09-01
Visera Elite II Video System Center (K201200)Olympus Medical Systems Corp.2020-07-22
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 (K200542)Olympus Medical Systems Corp.2020-07-17
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 (K192793)Olympus Medical Systems Corp.2020-07-17
Thunderbeat Open Fine Jaw Type X Hand Instrument (K192103)Olympus Medical Systems Corp.2020-05-11
Single Use Injector (K192498)Olympus Medical Systems Corp.2020-04-28
Single Use Biopsy Forceps FB-456D (K200397)Olympus Medical Systems Corp.2020-04-24
Visera Elite II Video System Center, Visera Elite II Endoeye 3D (K193026)Olympus Medical Systems Corp.2020-04-03
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR (K192164)Olympus Medical Systems Corp.2020-03-06
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K193182)Olympus Medical Systems Corp.2020-01-17
Single Use Balloon Dilator V (with knife) (K193039)Olympus Medical Systems Corp.2019-12-17
Single Use Aspiration Needle (K190239)Olympus Medical Systems Corp.2019-12-10
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (K190772)Olympus Medical Systems Corp.2019-10-10
Rhino-Laryngo Videoscope Olympus ENF-VT3 (K183416)Olympus Medical Systems Corp.2019-09-06
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (K183525)Olympus Medical Systems Corp.2019-09-06
EVIS EXERA III Bronchovideoscope Olympus BF-XT190 (K183419)Olympus Medical Systems Corp.2019-09-05
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head (K190449)Olympus Medical Systems Corp.2019-08-30
Single Use Cytology Brush BC-205D (K190293)Olympus Medical Systems Corp.2019-08-02
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip (K183590)Olympus Medical Systems Corp.2019-08-01
ENDOSCOPE REPROCESSOR OER-Elite (K190969)Olympus Medical Systems Corp.2019-07-09
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 (K182408)Olympus Medical Systems Corp.2019-05-15
Olympus Small Intestinal Capsule Endoscope System (K183053)Olympus Medical Systems Corp.2019-03-05
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 (K182102)Olympus Medical Systems Corp.2019-02-06
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R (K181451)Olympus Medical Systems Corp.2019-01-16
Single Use Hot Biopsy Forceps FD-231 (K173495)Olympus Medical Systems Corp.2018-11-30
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (K180668)Olympus Medical Systems Corp.2018-11-15
Single Use Aspiration Needle NA-U201H (K181994)Olympus Medical Systems Corp.2018-10-31
Rhino-Laryngo Fiberscope Olympus ENF-GP2 (K181240)Olympus Medical Systems Corp.2018-10-04
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 (K180575)Olympus Medical Systems Corp.2018-07-12
Single Use Aspiration Needle NA-U200H (K180449)Olympus Medical Systems Corp.2018-06-08
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D (K172726)Olympus Medical Systems Corp.2018-04-30
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 (K172610)Olympus Medical Systems Corp.2018-04-17
OLYMPUS URF-V2/V2R (K172246)Olympus Medical Systems Corp.2018-03-30
OLYMPUS URF-P6/P6R (K172298)Olympus Medical Systems Corp.2018-03-29
Olympus Small Intestinal Capsule Endoscope System (K173459)Olympus Medical Systems Corp.2018-03-13
Single Use Electrosurgical Snare SD-400 (K172734)Olympus Medical Systems Corp.2017-12-07
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 (K172618)Olympus Medical Systems Corp.2017-12-05
Single Use Retrieval Nitinol Basket V (K170811)Olympus Medical Systems Corp.2017-11-27
Single Use Electrosurgical knife (K171158)Olympus Medical Systems Corp.2017-11-17
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA (K172817)Olympus Medical Systems Corp.2017-10-17
Single Use Hot Biopsy Forceps FD-231 (K171916)Olympus Medical Systems Corp.2017-10-13
Ultrasonic Generator (K172691)Olympus Medical Systems Corp.2017-10-04
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K163069)Olympus Medical Systems Corp.2017-01-19
Disposal Lens Cleaning Sheath (K153773)Olympus Medical Systems Corp.2016-11-22
Single Use Aspiration Needle NA-U401SX (K160098)Olympus Medical Systems Corp.2016-03-22
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 (K160241)Olympus Medical Systems Corp.2016-03-02
THUNDERBEAT Open Fine Jaw (K151743)Olympus Medical Systems Corp.2016-02-26
Single Use Injector NM600/610 (K153625)Olympus Medical Systems Corp.2016-02-12
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V (K143153)Olympus Medical Systems Corp.2016-01-15
Single Use Aspiration Needle NA-U200H (K151738)Olympus Medical Systems Corp.2015-11-20
Single Use Balloon Dilator V (with Knife) (K150142)Olympus Medical Systems Corp.2015-10-08
VISERA 4K UHD SYSTEM (K151011)Olympus Medical Systems Corp.2015-10-01
Single Use Biliary Balloon Dilator (K143303)Olympus Medical Systems Corp.2015-02-27
ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT (K142680)Olympus Medical Systems Corp.2015-02-08
THUNDERBEAT (K132703)Olympus Medical Systems Corp.2014-05-19
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT (K134026)Olympus Medical Systems Corp.2014-03-07
EVIS EXERA III VIDEO SYSTEM (K131780)Olympus Medical Systems Corp.2013-08-29
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM (K123421)Olympus Medical Systems Corp.2013-04-29
SINGLE USE REPOSITIONABLE CLIP (K123601)Olympus Medical Systems Corp.2013-04-29
SINGLE USE PRELOADED SPHINCTEROTOME V (K122505)Olympus Medical Systems Corp.2013-04-11
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 (K123365)Olympus Medical Systems Corp.2013-03-01
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 (K130058)Olympus Medical Systems Corp.2013-02-22
AUTOMATED ENDOSCOPE LEAK TESTER (K123704)Olympus Medical Systems Corp.2013-02-04
EVIS EXERA III VIDEO SYSTEM (K121959)Olympus Medical Systems Corp.2013-01-10
ENDOSCOPE REPROCESSOR OER-MINI (K120357)Olympus Medical Systems Corp.2012-12-20
VIDEO SYSTEM CENTER (K122831)Olympus Medical Systems Corp.2012-12-14
ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 (K121564)Olympus Medical Systems Corp.2012-10-16
CHF-Y0005 (K113120)Olympus Medical Systems Corp.2012-09-25
WIRELESS IMAGE TRANSMITTER UNIT (K120278)Olympus Medical Systems Corp.2012-08-10
SYSTEMS INTEGRATION (K121701)Olympus Medical Systems Corp.2012-06-29
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