Company ยท CN
Bain Medical Equipment (Guangzhou) Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2026 | K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FJK |
| Jun 28, 2024 | K240164 | NovaLine SP-C35 Transducer Protector (956007) Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FIB |
| Apr 8, 2022 | K213015 | DORA Disposable A.V. Fistula Needle Sets Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FIE |
| Mar 10, 2021 | K201866 | NovaLine Tubing Sets for Hemodialysis Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FJK |
| Feb 25, 2021 | K203524 | Surgical Masks Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FXX |
| Jul 20, 2017 | K163025 | DORA Disposable A.V. Fistula Needle Sets Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FIE |
| Jun 16, 2017 | K161582 | DORA Tubing Sets for Hemodialysis Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FJK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||