Bain Medical Equipment (Guangzhou) Co., Ltd. - FDA 510(k) Cleared Dev...
Recent clearances: NovaLine Tubing Set for Hemodialysis (BL 124), NovaLine SP-C35 Transducer Protector (956007), DORA Disposable A.V. Fistula Needle Sets
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bain Medical Equipment (Guangzhou) Co., Ltd. Gastroenterology & Urology ✕
6 devices
Cleared
May 15, 2026
NovaLine Tubing Set for Hemodialysis (BL 124)
Gastroenterology & Urology
287d
Cleared
Jun 28, 2024
NovaLine SP-C35 Transducer Protector (956007)
Gastroenterology & Urology
158d
Cleared
Apr 08, 2022
DORA Disposable A.V. Fistula Needle Sets
Gastroenterology & Urology
200d
Cleared
Mar 10, 2021
NovaLine Tubing Sets for Hemodialysis
Gastroenterology & Urology
246d
Cleared
Jul 20, 2017
DORA Disposable A.V. Fistula Needle Sets
Gastroenterology & Urology
262d
Cleared
Jun 16, 2017
DORA Tubing Sets for Hemodialysis
Gastroenterology & Urology
373d