Company ยท CN
Guangdong Horigen Mother & Baby Products Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 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 |
|---|---|---|---|
| Sep 1, 2026 | K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
| May 6, 2022 | K212564 | Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
| May 4, 2021 | K201152 | Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
| Mar 7, 2021 | K201974 | Single-use medical face mask Guangdong Horigen Mother & Baby Products Co., Ltd., CN | FXX |
| Sep 11, 2020 | K193449 | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
| Mar 7, 2019 | K182413 | Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
| Dec 8, 2016 | K162747 | Proture Double Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd., CN | HGX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||