Medical Device Manufacturer · TW , Taichung City

Sunder Biomedical Tech. Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2001

Recent clearances: RENAX A.V. FISTULA NEEDLE SETS

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sunder Biomedical Tech. Co., Ltd. Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared Nov 18, 2002

RENAX HEMODIALYSIS BLOOD TUBING SET

Gastroenterology & Urology · 336d

Cleared May 04, 2001

RENAX A.V. FISTULA NEEDLE SETS

Gastroenterology & Urology · 211d