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Bain Medical Equipment (Guangzhou) Co., Ltd.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories4
Latest FDA decision2026-05-15
TypeNumberDevice NameCodeDateActions
510(k) K252423 NovaLine Tubing Set for Hemodialysis (BL 124)FJK2026-05-15 View
510(k) K240164 NovaLine SP-C35 Transducer Protector (956007)FIB2024-06-28 View
510(k) K213015 DORA Disposable A.V. Fistula Needle SetsFIE2022-04-08 View
510(k) K201866 NovaLine Tubing Sets for HemodialysisFJK2021-03-10 View
510(k) K203524 Surgical MasksFXX2021-02-25 View
510(k) K163025 DORA Disposable A.V. Fistula Needle SetsFIE2017-07-20 View
510(k) K161582 DORA Tubing Sets for HemodialysisFJK2017-06-16 View