| AMS 700 Inflatable Penile Prosthesis (with and without InhibiZone) (N970012/S197) | Boston Scientific Corp | 2023-11-14 |
| OrganOx metra System (P200035/S012) | Organox Limited | 2023-10-27 |
| Gambro Prismaflex TPE 2000 Set (P830063/S026) | Vantive US Healthcare, LLC | 2023-10-27 |
| Axonics Sacral Neuromodulation System (P190006/S071) | Boston Scientific Corporation | 2023-10-23 |
| Axonics Sacral Neuromodulation System (P180046/S071) | Boston Scientific Corporation | 2023-10-23 |
| InterStim Therapy System, Verify Evaluation System (P970004/S387) | Medtronic Neuromodulation | 2023-10-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S282) | Medtronic Neuromodulation | 2023-10-13 |
| COAPTITE Injectable Implant (P040047/S073) | Merz North America, Inc. | 2023-10-12 |
| Axonics Sacral Neuromodulation System (P180046/S074) | Boston Scientific Corporation | 2023-10-11 |
| Axonics Sacral Neuromodulation System (P190006/S074) | Boston Scientific Corporation | 2023-10-11 |
| Axonics Sacral Neuromodulation System (P190006/S073) | Boston Scientific Corporation | 2023-09-26 |
| Axonics Sacral Neuromodulation System (P180046/S073) | Boston Scientific Corporation | 2023-09-26 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone, AMS Ambicor Inflatable Pe (N970012/S196) | Boston Scientific Corp | 2023-09-20 |
| Coaptite Injectable Implant (P040047/S072) | Merz North America, Inc. | 2023-09-20 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S199) | Boston Scientific Corp | 2023-09-15 |
| COAPTITE Injectable Implant (P040047/S071) | Merz North America, Inc. | 2023-09-13 |
| OrganOx metra System (P200035/S009) | Organox Limited | 2023-09-06 |
| Axonics Sacral Neuromodulation System (P190006/S072) | Boston Scientific Corporation | 2023-08-25 |
| Optilume BPH Catheter System (P220029/S001) | Urotronic, Inc. | 2023-08-25 |
| Axonics Sacral Neuromodulation System (P180046/S072) | Boston Scientific Corporation | 2023-08-25 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK (P860003/S110) | Therakos Development Limited | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S389) | Medtronic Neuromodulation | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S283) | Medtronic Neuromodulation | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S388) | Medtronic Neuromodulation | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S284) | Medtronic Neuromodulation | 2023-08-10 |
| OrganOx metra® System (P200035/S010) | Organox Limited | 2023-08-09 |
| XVIVO Perfusion System (XPS) with STEEN Solution (P180014/S010) | Xvivo Perfusion, Inc. | 2023-08-09 |
| OrganOx metra® System (P200035/S006) | Organox Limited | 2023-08-08 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S281) | Medtronic Neuromodulation | 2023-08-03 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S386) | Medtronic Neuromodulation | 2023-08-03 |
| Bulkamid Urethral Bulking System (P170023/S015) | Boston Scientific Corporation | 2023-07-12 |
| Deflux Injectable Gel (P000029/S096) | Palette Life Sciences | 2023-07-11 |
| Solesta Injectable Gel (P100014/S034) | Palette Life Sciences | 2023-07-11 |
| Optilume BPH Catheter System (P220029) | Urotronic, Inc. | 2023-06-30 |
| Organ Care System (OCS) Liver (P200031/S004) | TransMedics, Inc. | 2023-06-28 |
| AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S198) | Boston Scientific Corp | 2023-06-28 |
| Organ Care System (OCS) Lung System (P160013/S013) | TransMedics, Inc. | 2023-06-28 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S131) | Boston Scientific Corp | 2023-06-28 |
| Organ Care System (OCS) Lung (P160013/S014) | TransMedics, Inc. | 2023-06-28 |
| Axonics Sacral Neuromodulation System (P180046/S069) | Boston Scientific Corporation | 2023-06-21 |
| Axonics Sacral Neuromodulation System (P190006/S069) | Boston Scientific Corporation | 2023-06-21 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S279) | Medtronic Neuromodulation | 2023-06-21 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S384) | Medtronic Neuromodulation | 2023-06-21 |
| Therakos CELLEX Photopheresis Kit (P860003/S103) | Therakos Development Limited | 2023-06-16 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S278) | Medtronic Neuromodulation | 2023-06-14 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S383) | Medtronic Neuromodulation | 2023-06-14 |
| Axonics Sacral Neuromodulation System (P180046/S063) | Boston Scientific Corporation | 2023-06-13 |
| Axonics Sacral Neuromodulation System (P190006/S063) | Boston Scientific Corporation | 2023-06-13 |
| eCoin implanted tibial stimulator (P200036/S006) | Boston Scientific Corporation | 2023-06-12 |
| Axonics Sacral Neuromodulation System (P190006/S066) | Boston Scientific Corporation | 2023-06-02 |
| Axonics Sacral Neuromodulation System (P180046/S066) | Boston Scientific Corporation | 2023-06-02 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S277) | Medtronic Neuromodulation | 2023-06-02 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S382) | Medtronic Neuromodulation | 2023-06-02 |
| Axonics Sacral Neuromodulation System (P180046/S068) | Boston Scientific Corporation | 2023-05-16 |
| Axonics Sacral Neuromodulation System (P190006/S068) | Boston Scientific Corporation | 2023-05-16 |
| Organ Care System (OCS) Liver (P200031/S003) | TransMedics, Inc. | 2023-05-09 |
| Macroplastique Implants (P040050/S013) | Uroplasty, LLC | 2023-05-09 |
| Organ Care System (OCS) Lung System (P160013/S012) | TransMedics, Inc. | 2023-05-09 |
| InterStim® Therapy System, Verify ® Evaluation System (P970004/S381) | Medtronic Neuromodulation | 2023-05-05 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S276) | Medtronic Neuromodulation | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S380) | Medtronic Neuromodulation | 2023-05-04 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S275) | Medtronic Neuromodulation | 2023-05-04 |
| Optilume Urethral Drug Coated Balloon (P210020/S008) | Urotronic, Inc. | 2023-04-25 |
| Bulkamid Urethral Bulking System (P170023/S014) | Boston Scientific Corporation | 2023-04-19 |
| OrganOx metra System (P200035/S008) | Organox Limited | 2023-04-18 |
| InterStim Therapy System, Verify Evaluation System (P970004/S364) | Medtronic Neuromodulation | 2023-04-12 |
| InterStim Therapy System, Verify Evaluation System (P080025/S259) | Medtronic Neuromodulation | 2023-04-12 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S274) | Medtronic Neuromodulation | 2023-04-04 |
| Axonics Sacral Neuromodulation System (P190006/S067) | Boston Scientific Corporation | 2023-04-04 |
| Axonics Sacral Neuromodulation System (P180046/S067) | Boston Scientific Corporation | 2023-04-04 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S379) | Medtronic Neuromodulation | 2023-04-04 |
| Prismaflex TPE2000 (P830063/S025) | Vantive US Healthcare, LLC | 2023-03-29 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S353) | Medtronic Neuromodulation | 2023-03-14 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S248) | Medtronic Neuromodulation | 2023-03-14 |
| eCoin implanted tibial stimulator (P200036/S005) | Boston Scientific Corporation | 2023-03-13 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK (P860003/S109) | Therakos Development Limited | 2023-03-13 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S064) | Coloplast Corp. | 2023-03-03 |
| Axonics Sacral Neuromodulation System (P190006/S065) | Boston Scientific Corporation | 2023-03-02 |
| Axonics Sacral Neuromodulation System (P180046/S065) | Boston Scientific Corporation | 2023-03-02 |
| LIPOSORBER LA-15 System (P910018/S035) | Kaneka Pharma America Corp. | 2023-03-01 |
| Organ Care System (OCS) Lung System (P160013/S010) | TransMedics, Inc. | 2023-02-24 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone (P000053/S129) | Boston Scientific Corp | 2023-02-23 |
| Organ Care System (OCS) Lung (P160013/S011) | TransMedics, Inc. | 2023-02-23 |
| Organ Care System (OCS) Liver (P200031/S002) | TransMedics, Inc. | 2023-02-23 |
| Spatz3 Adjustable Balloon System (P190012/S002) | Spatz Fgia, Inc. | 2023-02-15 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S066) | Coloplast Corp. | 2023-02-15 |
| OrganOx metra® System (P200035/S005) | Organox Limited | 2023-02-14 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S195) | Boston Scientific Corp | 2023-02-10 |
| Axonics Sacral Neuromodulation System (P190006/S054) | Boston Scientific Corporation | 2023-02-07 |
| Axonics Sacral Neuromodulation System (P180046/S054) | Boston Scientific Corporation | 2023-02-07 |
| Axonics Sacral Neuromodulation System (P180046/S064) | Boston Scientific Corporation | 2023-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S064) | Boston Scientific Corporation | 2023-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S056) | Boston Scientific Corporation | 2023-01-30 |
| Axonics Sacral Neuromodulation System (P180046/S056) | Boston Scientific Corporation | 2023-01-30 |
| COAPTITE Injectable Impant (P040047/S064) | Merz North America, Inc. | 2023-01-24 |
| Spatz3 Adjustable Balloon System (P190012/S003) | Spatz Fgia, Inc. | 2023-01-23 |
| P040047 COAPTITE® Injectable Implant (P040047/S069) | Merz North America, Inc. | 2023-01-12 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S065) | Coloplast Corp. | 2023-01-12 |
| VIRTIS SACRAL NEUROMODULATION SYSTEM (P170001) | Cirtec Medical Corporation | 2023-01-11 |