Olympus Winter & Ibe GmbH - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
Olympus Winter & Ibe GmbH has 42 FDA 510(k) cleared medical devices. Based in Melville, US.
Latest FDA clearance: Sep 2025. 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 Surgical Technologies of the Americas and Olympus Corporation of the Americas (Oca).
42 devices
Cleared
Sep 23, 2025
Bipolar applicator CelonProBreath (WB990310)
Ear, Nose, Throat
85d
Cleared
Aug 18, 2023
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W),...
General & Plastic Surgery
63d
Cleared
Jan 19, 2023
HF-cables (resusable)
Gastroenterology & Urology
238d
Cleared
Jan 13, 2023
Light-Guide Cables
General & Plastic Surgery
93d
Cleared
Dec 22, 2021
Sheath, Stopcock Accessory
Obstetrics & Gynecology
84d
Cleared
Sep 15, 2021
Instrument tray, for semi-rigid ureteroscope
General Hospital
300d
Cleared
Aug 03, 2021
Resection Electrodes with HF cable
Obstetrics & Gynecology
152d
Cleared
May 17, 2021
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer...
General & Plastic Surgery
151d
Cleared
Apr 28, 2021
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
General & Plastic Surgery
173d
Cleared
Aug 28, 2020
OES Elite Ureteroscopes and Accessories
Gastroenterology & Urology
196d
Cleared
Aug 29, 2019
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Obstetrics & Gynecology
160d
Cleared
Nov 29, 2018
Device Electrosurgical Generator ESG-150
General & Plastic Surgery
70d
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