| K252140 | Heylo System | October 6, 2025 |
| K251116 | Luja Coudé | June 27, 2025 |
| K250270 | Luja Set | April 17, 2025 |
| K242049 | SureCath Set | November 26, 2024 |
| K241210 | Luja Coude | November 21, 2024 |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | November 12, 2024 |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retro | October 18, 2024 |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | July 26, 2024 |
| K233411 | Folysil Silicone Catheter | April 15, 2024 |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in | March 22, 2024 |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | October 26, 2023 |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | September 25, 2023 |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small pac | August 25, 2023 |
| K223821 | Self-Cath Closed System | August 2, 2023 |
| K221874 | Altis Single Incision Sling System | February 15, 2023 |
| K221401 | Self-Cath and Self-Cath Plus | December 2, 2022 |
| K222059 | SpeediCath Flex Set | September 21, 2022 |
| K220420 | Saffron Fixation System | June 10, 2022 |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral ste | June 8, 2022 |
| K210250 | SpeedCath Compact Male | April 26, 2022 |