| OrganOx metra System (P200035/S018) | Organox Limited | 2025-04-16 |
| OrganOx metra System (P200035/S023) | Organox Limited | 2025-04-15 |
| Axonics Sacral Neuromodulation System (P180046/S098) | Boston Scientific Corporation | 2025-04-11 |
| Axonics Sacral Neuromodulation System (P190006/S098) | Boston Scientific Corporation | 2025-04-11 |
| Axonics Sacral Neuromodulation System (P190006/S089) | Boston Scientific Corporation | 2025-04-02 |
| Axonics Sacral Neuromodulation System (P180046/S089) | Boston Scientific Corporation | 2025-04-02 |
| Coaptite (P040047/S076) | Merz North America, Inc. | 2025-04-01 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S206) | Boston Scientific Corp | 2025-03-18 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S420) | Medtronic Neuromodulation | 2025-03-14 |
| InterStim Therapy System, Verify Evaluation System (P080025/S315) | Medtronic Neuromodulation | 2025-03-14 |
| LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). (P910018/S037) | Kaneka Pharma America Corp. | 2025-03-05 |
| Bulkamid Urethral Bulking System (P170023/S020) | Boston Scientific Corporation | 2025-03-05 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S314) | Medtronic Neuromodulation | 2025-02-28 |
| OrganOx metra System (P200035/S021) | Organox Limited | 2025-02-28 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S419) | Medtronic Neuromodulation | 2025-02-28 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK (P860003/S111) | Therakos Development Limited | 2025-02-27 |
| InterStim Therapy System, Verify Evaluation System (P970004/S408) | Medtronic Neuromodulation | 2025-02-12 |
| nterStim Therapy System, Verify Evaluation System (P080025/S303) | Medtronic Neuromodulation | 2025-02-12 |
| Axonics Sacral Neuromodulation System (P190006/S097) | Boston Scientific Corporation | 2025-02-07 |
| Axonics Sacral Neuromodulation System (P180046/S097) | Boston Scientific Corporation | 2025-02-07 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S410) | Medtronic Neuromodulation | 2025-02-07 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S305) | Medtronic Neuromodulation | 2025-02-07 |
| Axonics Sacral Neuromodulation System (P190006/S094) | Boston Scientific Corporation | 2025-02-03 |
| Axonics Sacral Neuromodulation System (P180046/S094) | Boston Scientific Corporation | 2025-02-03 |
| Axonics Sacral Neuromodulation System (P190006/S079) | Boston Scientific Corporation | 2025-01-27 |
| Axonics Sacral Neuromodulation System (P180046/S079) | Boston Scientific Corporation | 2025-01-27 |
| LIPOSORBER® LA-15 System (P910018/S039) | Kaneka Pharma America Corp. | 2025-01-24 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S136) | Boston Scientific Corp | 2025-01-23 |
| Axonics Sacral Neuromodulation System (P180046/S096) | Boston Scientific Corporation | 2025-01-21 |
| Axonics Sacral Neuromodulation System (P190006/S096) | Boston Scientific Corporation | 2025-01-21 |
| MediBeacon® Transdermal GFR Measurement System (TGFR) (P230019) | Medibeacon, Inc. | 2025-01-17 |
| Axonics Sacral Neuromodulation System (P190006/S095) | Boston Scientific Corporation | 2025-01-16 |
| Axonics Sacral Neuromodulation System (P180046/S095) | Boston Scientific Corporation | 2025-01-16 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S418) | Medtronic Neuromodulation | 2025-01-15 |
| LIPOSORBER® LA-15 System (P910018/S036) | Kaneka Pharma America Corp. | 2025-01-15 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S313) | Medtronic Neuromodulation | 2025-01-15 |
| Organ Care System (OCS) Liver (P200031/S007) | TransMedics, Inc. | 2025-01-13 |
| InterStim Therapy System, Verify Evaluation System (P970004/S409) | Medtronic Neuromodulation | 2025-01-06 |
| InterStim Therapy System, Verify Evaluation System (P080025/S304) | Medtronic Neuromodulation | 2025-01-06 |
| Axonics Sacral Neuromodulation System (P190006/S084) | Boston Scientific Corporation | 2025-01-02 |
| Axonics Sacral Neuromodulation System (P180046/S084) | Boston Scientific Corporation | 2025-01-02 |
| alfapump System (P230044) | Sequana Medical NV | 2024-12-20 |
| InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator (P080025/S311) | Medtronic Neuromodulation | 2024-12-19 |
| InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator (P970004/S416) | Medtronic Neuromodulation | 2024-12-19 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S205) | Boston Scientific Corp | 2024-12-17 |
| OrganOx metra System (P200035/S020) | Organox Limited | 2024-12-17 |
| InterStim Therapy System, Verify Evaluation System (P080025/S312) | Medtronic Neuromodulation | 2024-12-16 |
| InterStim Therapy System, Verify Evaluation System (P970004/S417) | Medtronic Neuromodulation | 2024-12-16 |
| InterStim Therapy System, Verify Evaluation System (P080025/S306) | Medtronic Neuromodulation | 2024-12-13 |
| InterStim Therapy System (P970004/S411) | Medtronic Neuromodulation | 2024-12-13 |
| SNS Bowel Neurostimulator/Implantable InterStim (P080025/S308) | Medtronic Neuromodulation | 2024-12-12 |
| SNS Urinary Neurostimulator/Implantable InterStim (P970004/S413) | Medtronic Neuromodulation | 2024-12-12 |
| Gambro Prismaflex TPE 2000 Set (P830063/S029) | Vantive US Healthcare, LLC | 2024-12-06 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S415) | Medtronic Neuromodulation | 2024-12-05 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S310) | Medtronic Neuromodulation | 2024-12-05 |
| Axonics Sacral Neuromodulation System (P190006/S093) | Boston Scientific Corporation | 2024-11-27 |
| Axonics Sacral Neuromodulation System (P180046/S093) | Boston Scientific Corporation | 2024-11-27 |
| InterStim Therapy System, Verify Evaluation System (P970004/S412) | Medtronic Neuromodulation | 2024-11-25 |
| Axonics Sacral Neuromodulation System (P190006/S092) | Boston Scientific Corporation | 2024-11-25 |
| Axonics Sacral Neuromodulation System (P180046/S092) | Boston Scientific Corporation | 2024-11-25 |
| InterStim Therapy System, Verify Evaluation System (P080025/S307) | Medtronic Neuromodulation | 2024-11-25 |
| Bulkamid Urethral Bulking System (P170023/S019) | Boston Scientific Corporation | 2024-11-19 |
| Axonics Sacral Neuromodulation System (P180046/S091) | Boston Scientific Corporation | 2024-11-05 |
| Axonics Sacral Neuromodulation System (P190006/S091) | Boston Scientific Corporation | 2024-11-05 |
| Gambro Prismaflex TPE 2000 Set (P830063/S028) | Vantive US Healthcare, LLC | 2024-10-24 |
| Axonics Sacral Neuromodulation System (P180046/S090) | Boston Scientific Corporation | 2024-10-21 |
| Axonics Sacral Neuromodulation System (P190006/S090) | Boston Scientific Corporation | 2024-10-21 |
| InterStim® Therapy System (P080025/S302) | Medtronic Neuromodulation | 2024-10-11 |
| InterStim® Therapy System (P970004/S407) | Medtronic Neuromodulation | 2024-10-11 |
| Organ Care System (OCS) Lung (P160013/S018) | TransMedics, Inc. | 2024-10-11 |
| Organ Care System (OCS) Liver (P200031/S009) | TransMedics, Inc. | 2024-10-11 |
| AMS 800 Artificial Urinary Sphincter (with and without InhibiZone) (P000053/S130) | Boston Scientific Corp | 2024-10-08 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S069) | Coloplast Corp. | 2024-10-02 |
| InterStim Therapy System, Verify Evaluation System (P080025/S301) | Medtronic Neuromodulation | 2024-09-30 |
| InterStim Therapy System, Verify Evaluation System (P970004/S406) | Medtronic Neuromodulation | 2024-09-30 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| LIPOSORBER LA-15 System (P910018/S040) | Kaneka Pharma America Corp. | 2024-09-26 |
| OrganOx metra System (P200035/S015) | Organox Limited | 2024-09-26 |
| XPS with Steen Solution Perfusate (P180014/S011) | Xvivo Perfusion, Inc. | 2024-09-20 |
| Axonics Sacral Neuromodulation System (P180046/S088) | Boston Scientific Corporation | 2024-09-18 |
| Axonics Sacral Neuromodulation System (P190006/S088) | Boston Scientific Corporation | 2024-09-18 |
| Axonics Sacral Neuromodulation System (P180046/S080) | Boston Scientific Corporation | 2024-09-16 |
| InterStim Therapy System (P970004/S405) | Medtronic Neuromodulation | 2024-09-16 |
| Axonics Sacral Neuromodulation System (P190006/S080) | Boston Scientific Corporation | 2024-09-16 |
| InterStim Therapy System (P080025/S300) | Medtronic Neuromodulation | 2024-09-16 |
| OrganOx metra® System (P200035/S017) | Organox Limited | 2024-09-09 |
| Axonics Sacral Neuromodulation System (P190006/S087) | Boston Scientific Corporation | 2024-09-04 |
| Axonics Sacral Neuromodulation System (P180046/S087) | Boston Scientific Corporation | 2024-09-04 |
| Bulkamid Urethral Bulking System (P170023/S018) | Boston Scientific Corporation | 2024-09-03 |
| LIPOSORBER® LA-15 System (P910018/S038) | Kaneka Pharma America Corp. | 2024-08-27 |
| OrganOx metra System (P200035/S016) | Organox Limited | 2024-08-23 |
| OrganOx metra® System (P200035/S004) | Organox Limited | 2024-08-22 |
| Optilume BPH Catheter System (P220029/S002) | Urotronic, Inc. | 2024-08-15 |
| InterStim Therapy System, Verify® Evaluation System (P970004/S403) | Medtronic Neuromodulation | 2024-08-14 |
| InterStim Therapy System, Verify Evaluation System (P080025/S298) | Medtronic Neuromodulation | 2024-08-14 |
| Axonics Sacral Neuromodulation System (P180046/S078) | Boston Scientific Corporation | 2024-08-02 |
| Axonics Sacral Neuromodulation System (P190006/S078) | Boston Scientific Corporation | 2024-08-02 |
| Bulkamid Urethral Bulking System (P170023/S017) | Boston Scientific Corporation | 2024-07-30 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S404) | Medtronic Neuromodulation | 2024-07-29 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S299) | Medtronic Neuromodulation | 2024-07-29 |