Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

104 results for "Olympus Medical Systems Corp."
1–24 of 104
Search insights Median review: 147d Cleared: 100% Top manufacturer: Olympus Medical Systems Corp. Lead specialty: Gastroenterology & Urology
Cleared Sep 10, 2026
4K Camera Head OLYMPUS CH-S700-08-LB
K262079 · FET
Olympus Medical Systems Corp.
General & Plastic Surgery · 80d
Cleared Jul 01, 2026
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)
K254056 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 196d
Cleared May 21, 2026
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K260580 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared Apr 23, 2026
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
K252341 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Mar 06, 2026
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
K251807 · KGE
Olympus Medical Systems Corp.
Gastroenterology & Urology · 267d
Cleared Feb 22, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d
Cleared Nov 12, 2025
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)
K251336 · OWN
Olympus Medical Systems Corp.
General & Plastic Surgery · 196d
Cleared Oct 24, 2025
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 64d
Cleared Oct 17, 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 203d
Cleared Sep 19, 2025
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
K251867 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d
Cleared Jun 23, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190)
K250862 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 94d
Cleared Jun 05, 2025
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
K250701 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 27, 2025
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
K250573 · ODD
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 01, 2025
Disposable Distal Attachment D-201 Series
K250296 · FDS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared Mar 31, 2025
Disposable Grasping Forceps FG-52D/FG-54D
K250263 · KTI
Olympus Medical Systems Corp.
Anesthesiology · 61d
Cleared Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · LQR
Olympus Medical Systems Corp.
Gastroenterology & Urology · 97d
Cleared Jun 03, 2024
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K240617 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared Dec 29, 2022
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE...
K221690 · FAJ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 202d
Cleared Dec 28, 2022
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 203d
Cleared Sep 26, 2022
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation...
K221631 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 112d
Cleared Sep 19, 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 105d
Cleared May 11, 2022
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 71d
Cleared Mar 09, 2022
4K UHD LCD Monitor OEV321UH
K220069 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 58d
Cleared Sep 22, 2021
Single Use Guide Sheath Kit-401, K-402
K212667 · EOQ
Olympus Medical Systems Corp.
Anesthesiology · 30d