| Gambro Prismaflex TPE 2000 Set (P830063/S031) | Vantive US Healthcare, LLC | 2025-12-23 |
| InterStim Therapy System, Verify Evaluation System (P080025/S337) | Medtronic Neuromodulation | 2025-12-23 |
| InterStim Therapy System, Verify Evaluation System (P970004/S442) | Medtronic Neuromodulation | 2025-12-23 |
| InterStim Therapy System; Verify Evaluation System (P970004/S441) | Medtronic Neuromodulation | 2025-12-22 |
| InterStim Therapy System; Verify Evaluation System (P080025/S336) | Medtronic Neuromodulation | 2025-12-22 |
| Axonics Sacral Neuromodulation System (P190006/S101) | Boston Scientific Corporation | 2025-12-19 |
| alfapump System (P230044/S002) | Sequana Medical NV | 2025-12-19 |
| Medtronic Altaviva System (P240011/S004) | Medtronic Neuromodulation | 2025-12-19 |
| Axonics Sacral Neuromodulation System (P180046/S101) | Boston Scientific Corporation | 2025-12-19 |
| OrganOx metra® System (P200035/S031) | Organox Limited | 2025-12-17 |
| Organ Care System (OCS) Liver (P200031/S012) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Lung System (P160013/S020) | TransMedics, Inc. | 2025-12-16 |
| Optilume BPH Catheter System (P220029/S003) | Urotronic, Inc. | 2025-12-15 |
| MediBeacon® Transdermal GFR Measurement System (TGFR) (P230019/S001) | Medibeacon, Inc. | 2025-12-15 |
| Optilume BPH Catheter System (P220029/S004) | Urotronic, Inc. | 2025-12-12 |
| COAPTITE (P040047/S079) | Merz North America, Inc. | 2025-12-12 |
| Zenflow Spring® Implant and Delivery System (P250007) | Zenflow, Inc. | 2025-12-11 |
| ProVee System for BPH (P250011) | Proverum, Ltd. | 2025-12-09 |
| InterStim Therapy System, Verify Evaluation System (P080025/S334) | Medtronic Neuromodulation | 2025-11-26 |
| Altaviva (P240011/S003) | Medtronic Neuromodulation | 2025-11-26 |
| InterStim Therapy System, Verify Evaluation System (P970004/S439) | Medtronic Neuromodulation | 2025-11-26 |
| XPS with Steen Solution Perfusate (P180014/S013) | Xvivo Perfusion, Inc. | 2025-11-25 |
| THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE (P860003/S112) | Therakos Development Limited | 2025-11-21 |
| MediBeacon® Transdermal GFR Measurement System (GFR) (P230019/S003) | Medibeacon, Inc. | 2025-11-20 |
| nterStim Therapy System, Verify Evaluation System (P080025/S321) | Medtronic Neuromodulation | 2025-11-04 |
| InterStim Therapy System, Verify Evaluation System (P970004/S426) | Medtronic Neuromodulation | 2025-11-04 |
| Organ Care System (OCS) Lung System (P160013/S019) | TransMedics, Inc. | 2025-10-22 |
| Organ Care System (OCS) Liver (P200031/S011) | TransMedics, Inc. | 2025-10-22 |
| Altaviva Implantable Neurostimulator (P240011/S002) | Medtronic Neuromodulation | 2025-10-21 |
| Altaviva Implantable Neurostimulator (P240011/S001) | Medtronic Neuromodulation | 2025-10-17 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S333) | Medtronic Neuromodulation | 2025-10-16 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S438) | Medtronic Neuromodulation | 2025-10-16 |
| LINX Reflux Management System (P100049/S038) | Torax Medical | 2025-10-08 |
| ProACT Adjustable Continence Therapy for Men (P130018/S004) | Uromedica, Inc. | 2025-10-03 |
| eCoin Tibial Nerve Stimulator System (P200036/S009) | Boston Scientific Corporation | 2025-10-02 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S210) | Boston Scientific Corp | 2025-10-02 |
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| Plasmaflo OP-05W(A) (P820033/S017) | Asahi Kasei Medical Co., Ltd. | 2025-09-30 |
| OrganOx metra® System (P200035/S030) | Organox Limited | 2025-09-19 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator 97800); (SNS Bowel Neurostimulators Impl (P080025/S330) | Medtronic Neuromodulation | 2025-09-18 |
| Medtronic Altaviva System (P240011) | Medtronic Neuromodulation | 2025-09-18 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator 97800); (SNS Urinary Neurostimulator I (P970004/S435) | Medtronic Neuromodulation | 2025-09-18 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S331) | Medtronic Neuromodulation | 2025-09-15 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S436) | Medtronic Neuromodulation | 2025-09-15 |
| InterStim® Therapy System (P080025/S316) | Medtronic Neuromodulation | 2025-09-10 |
| InterStim® Therapy System (P970004/S421) | Medtronic Neuromodulation | 2025-09-10 |
| OrganOx metra® System (P200035/S029) | Organox Limited | 2025-09-08 |
| InterStim® Therapy System; Verify® Evaluation System (P970004/S434) | Medtronic Neuromodulation | 2025-09-05 |
| InterStim® Therapy System; Verify® Evaluation System (P080025/S329) | Medtronic Neuromodulation | 2025-09-05 |
| InterStim Therapy System; Verify Evaluation System (P080025/S328) | Medtronic Neuromodulation | 2025-08-28 |
| OrganOx metra® System (P200035/S028) | Organox Limited | 2025-08-28 |
| InterStim Therapy System; Verify Evaluation System (P970004/S433) | Medtronic Neuromodulation | 2025-08-28 |
| COAPTITE Injectable Implant (P040047/S078) | Merz North America, Inc. | 2025-08-27 |
| OrganOx metra System (P200035/S026) | Organox Limited | 2025-08-22 |
| OrganOx metra® System (P200035/S025) | Organox Limited | 2025-08-20 |
| Neuspera Sacral Neuromodulation System (P240031/S001) | Neuspera Medical, Inc. | 2025-08-15 |
| Titan Inflatable Penile Prosthesis (P000006/S071) | Coloplast Corp. | 2025-08-14 |
| InterStim Therapy System, Verify Evaluation System (P970004/S432) | Medtronic Neuromodulation | 2025-08-06 |
| InterStim Therapy System, Verify Evaluation System (P080025/S327) | Medtronic Neuromodulation | 2025-08-06 |
| InterStim Therapy System, Verify Evaluation System (P080025/S326) | Medtronic Neuromodulation | 2025-08-01 |
| InterStim Therapy System, Verify Evaluation System (P970004/S431) | Medtronic Neuromodulation | 2025-08-01 |
| InterStim Therapy System; Verify Evaluation System (P970004/S430) | Medtronic Neuromodulation | 2025-07-28 |
| InterStim Therapy System; Verify Evaluation System (P080025/S325) | Medtronic Neuromodulation | 2025-07-28 |
| OrganOx metra® System (P200035/S027) | Organox Limited | 2025-07-18 |
| InterStim Therapy System, Verify Evaluation System (P080025/S324) | Medtronic Neuromodulation | 2025-07-17 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S427) | Medtronic Neuromodulation | 2025-07-17 |
| InterStim Therapy System, Verify Evaluation System (P970004/S428) | Medtronic Neuromodulation | 2025-07-17 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S322) | Medtronic Neuromodulation | 2025-07-17 |
| InterStim Therapy System, Verify Evaluation System (P080025/S323) | Medtronic Neuromodulation | 2025-07-16 |
| eCoin Peripheral Neurostimulator (P200036/S008) | Boston Scientific Corporation | 2025-07-16 |
| InterStim Therapy System, Verify Evaluation System (P970004/S429) | Medtronic Neuromodulation | 2025-07-16 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S140) | Boston Scientific Corp | 2025-07-14 |
| AMS 700 Inflatable Penile Prosthesis (IPP) (N970012/S209) | Boston Scientific Corp | 2025-07-14 |
| ReShape Lap-Band System (P000008/S051) | Medtimo, Inc. | 2025-07-11 |
| Orbera® Intragastric Balloon (IGB) System (P140008/S027) | Boston Scientific Corporation | 2025-07-11 |
| alfapump System (P230044/S001) | Sequana Medical NV | 2025-07-09 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S208) | Boston Scientific Corp | 2025-07-01 |
| Organ Care System (OCS) Liver (P200031/S010) | TransMedics, Inc. | 2025-07-01 |
| OrganOx metra System (P200035/S024) | Organox Limited | 2025-07-01 |
| THERAKOS® CELLEX® Photopheresis System Procedural Kit (P860003/S113) | Therakos Development Limited | 2025-06-30 |
| Optilume Urethral Drug Coated Balloon Catheter (P210020/S010) | Urotronic, Inc. | 2025-06-23 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S320) | Medtronic Neuromodulation | 2025-06-18 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S425) | Medtronic Neuromodulation | 2025-06-18 |
| Neuspera Sacral Neuromodulation System (P240031) | Neuspera Medical, Inc. | 2025-06-17 |
| COAPTITE® (P040047/S077) | Merz North America, Inc. | 2025-06-16 |
| OrganOx metra System (P200035/S022) | Organox Limited | 2025-06-10 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (P000053/S137) | Boston Scientific Corp | 2025-06-03 |
| OrganOx metra® System (P200035/S019) | Organox Limited | 2025-06-02 |
| Titan Inflatable Penile Prosthesis (P000006/S070) | Coloplast Corp. | 2025-05-28 |
| AMS 700 Inflatable Penile Prosthesis without InhibiZone (N970012/S207) | Boston Scientific Corp | 2025-05-28 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S139) | Boston Scientific Corp | 2025-05-28 |
| Bulkamid Urethral Bulking System (P170023/S021) | Boston Scientific Corporation | 2025-05-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S317) | Medtronic Neuromodulation | 2025-05-21 |
| InterStim® Therapy System,Verify® Evaluation System (P970004/S422) | Medtronic Neuromodulation | 2025-05-21 |
| Bulkamid Urethral Bulking System (P170023/S022) | Boston Scientific Corporation | 2025-05-20 |
| ProACT Adjustable Continence Therapy for Men (P130018/S003) | Uromedica, Inc. | 2025-05-20 |
| InterStimTM Therapy System, Verify® Evaluation System (P080025/S318) | Medtronic Neuromodulation | 2025-05-13 |
| InterStimTM Therapy System, Verify® Evaluation System (P970004/S423) | Medtronic Neuromodulation | 2025-05-13 |
| XPS with Steen Solution Perfusate (P180014/S012) | Xvivo Perfusion, Inc. | 2025-05-08 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |