Company ยท TW
Bonraybio Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 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 30, 2025 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer Bonraybio Co., Ltd., TW | POV |
| May 9, 2025 | K242388 | LensHooke X12 PRO Semen Analysis System Bonraybio Co., Ltd., TW | POV |
| Oct 31, 2022 | K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device Bonraybio Co., Ltd., TW | MQK |
| Oct 28, 2020 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer Bonraybio Co., Ltd., TW | POV |
| Nov 16, 2018 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd., TW | POV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||