| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 
| K183602 | SwimCount Sperm Quality Test | MotilityCount ApS | 
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | 
| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | 
| K161493 | YO Home Sperm Test | MEDICAL ELECTRONIC SYSTEMS, LTD | 
| K153683 | Trak Male Fertility Testing System | SANDSTONE DIAGNOSTICS, INC. | 
| K100341 | SPERMCHECK FERTILITY | PRINCETON BIOMEDITECH CORP. | 
| K073039 | SPERMCHECK VASECTOMY | PRINCETON BIOMEDITECH CORP. | 
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | MEDICAL ELECTRONIC SYSTEMS LTD. | 
| K041039 | FERTELL MALE FERTILITY TEST | GENOSIS LTD. | 
| K032874 | HBA SPERM-HYALURONAN BINDING ASSAY | BIOCOAT, INC. | 
| K021746 | SQA V, SPERM QUALITY ANALYZER | MEDICAL ELECTRONIC SYSTEMS, LLC | 
| K012805 | AUTOMARQER | HAMILTON THORNE RESEARCH | 
| K012352 | SQA, SPERM QUALITY ANALYZER | MEDICAL ELECTRONIC SYSTEMS, LLC | 
| K011679 | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY | EMBRYOTECH LABORATORIES, INC. |