Medical Device Manufacturer · US , Melville , NY

Olympus Winter & Ibe GmbH - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1997

Recent clearances: OES ELITE Cystoscope and Accessories, Bipolar applicator CelonProBreath (WB990310), Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)

43
Total
43
Cleared
0
Denied

Olympus Winter & Ibe GmbH has 43 FDA 510(k) cleared medical devices. Based in Melville, US.

Latest FDA clearance: May 2026. Active since 1997.

Browse the FDA 510(k) cleared devices submitted by Olympus Winter & Ibe GmbH Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Olympus Surgical Technologies America, Olympus Corporation of the Americas and Gyrus Acmi, Inc..

FDA 510(k) Regulatory Record - Olympus Winter & Ibe GmbH

43 devices
1-12 of 43

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