Medical Device Manufacturer · US , Melville , NY

Aomori Olympus Co., Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2003

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aomori Olympus Co., Ltd. Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared Nov 14, 2003

SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B

Gastroenterology & Urology · 29d

Cleared Apr 16, 2003

PANCREATIC DRAINAGE TUBE

Gastroenterology & Urology · 330d