Panels › Hematology › Product code POV · Class 2
Semen Analysis Device
Regulation 864.5220
1510(k)s in 12 months (28 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in POV
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Electronic Systems , Ltd. | 7 | 0 |
| Bonraybio Co., Ltd. | 4 | 0 |
| Embryotech Laboratories, Inc. | 2 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 2 |
| Hamilton Thorne Research | 2 | 0 |
| Princeton BioMeditech Corp. | 2 | 0 |
| Sandstone Diagnostics, Inc. | 2 | 0 |
| Biocoat, Inc. | 1 | 0 |
| Bioshaf , Ltd. | 1 | 0 |
| Checkcells, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Sperm Test Open, Classified |
POV | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Sperm Test Open, Classified |
POV | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.