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Semen Analysis Device
FDA product code POV · Class 2 · Hematology
78
Registered devices
1
Adverse events
2
Recalls
28
510(k) clearances
Devices with this code
Spermac Stain — VITROLIFE INC.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.LensHooke Semen Quality Analyzer — BONRAYBIO CO., LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.LensHooke Semen Test Cassette — BONRAYBIO CO., LTD.Trak — MEDTOX DIAGNOSTICS, INC.Men's Rapid Fertility Test — MEDTOX DIAGNOSTICS, INC.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.Spermac Stain — VITROLIFE INC.LensHooke Cleaning Wipe — BONRAYBIO CO., LTD.Men's Rapid Fertility Test — MEDTOX DIAGNOSTICS, INC.SQA-iOw Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.LensHooke Cleaning Wipe — BONRAYBIO CO., LTD.LensHooke semen Test Cassette — BONRAYBIO CO., LTD.LensHooke Semen Quality Analyzer — BONRAYBIO CO., LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.N/A — ORIGIO INC.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.YO Home Sperm Test — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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