| COAPTITE® Injectable Implant (P040047/S065) | Merz North America, Inc. | 2023-01-06 |
| Plasmaflo OP-05W(A) (P820033/S016) | Asahi Kasei Medical Co., Ltd. | 2023-01-05 |
| Axonics Sacral Neuromodulation System (Urinary) (P180046/S062) | Boston Scientific Corporation | 2022-12-19 |
| Axonics Sacral Neuromodulation System (bowel) (P190006/S062) | Boston Scientific Corporation | 2022-12-19 |
| COAPTITE® Injectable Implant (P040047/S068) | Merz North America, Inc. | 2022-12-15 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S273) | Medtronic Neuromodulation | 2022-12-08 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S378) | Medtronic Neuromodulation | 2022-12-08 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S063) | Coloplast Corp. | 2022-12-01 |
| COAPTITE Injectable Impant (P040047/S067) | Merz North America, Inc. | 2022-11-30 |
| eCoin Implant Tibial Stimulator (P200036/S004) | Boston Scientific Corporation | 2022-11-30 |
| COAPTITE® Injectable Implant (P040047/S066) | Merz North America, Inc. | 2022-11-29 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S376) | Medtronic Neuromodulation | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S272) | Medtronic Neuromodulation | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S377) | Medtronic Neuromodulation | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S271) | Medtronic Neuromodulation | 2022-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S375) | Medtronic Neuromodulation | 2022-11-16 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S270) | Medtronic Neuromodulation | 2022-11-16 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S194) | Boston Scientific Corp | 2022-11-14 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone (P000053/S128) | Boston Scientific Corp | 2022-11-14 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S193) | Boston Scientific Corp | 2022-11-09 |
| Gambro Prismaflex TPE 2000 Set (P830063/S024) | Vantive US Healthcare, LLC | 2022-11-08 |
| Axonics Sacral Neuromodulation System (Urinary) (P180046/S061) | Boston Scientific Corporation | 2022-11-01 |
| Axonics Sacral Neuromodulation System (Bowel) (P190006/S061) | Boston Scientific Corporation | 2022-11-01 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S374) | Medtronic Neuromodulation | 2022-10-27 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S269) | Medtronic Neuromodulation | 2022-10-27 |
| Durasphere Injectable Bulking Agent (P980053/S019) | Carbon Medical Technologies, Inc. | 2022-10-27 |
| Bulkamid Urethral Bulking System (P170023/S012) | Boston Scientific Corporation | 2022-10-26 |
| Bulkamid Urethral Bulking System (P170023/S013) | Boston Scientific Corporation | 2022-10-26 |
| The Spanner Temporary Prostatic Stent (P060010/S013) | Srs Medical | 2022-10-07 |
| ORBERA ® Intragastric Balloon (IGB) System (P140008/S024) | Boston Scientific Corporation | 2022-10-05 |
| LINX Reflux Management System (P100049/S033) | Torax Medical | 2022-10-04 |
| Optilume Urethral Drug Coated Balloon (P210020/S006) | Urotronic, Inc. | 2022-09-29 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO (P860003/S108) | Therakos Development Limited | 2022-09-23 |
| InterStim® Therapy System, Verify® Evaluation System, SNS Bowel Leads (P080025/S263) | Medtronic Neuromodulation | 2022-09-23 |
| InterStim® Therapy System, Verify® Evaluation System, SNS Urinary Leads (P970004/S368) | Medtronic Neuromodulation | 2022-09-23 |
| Organ Care System (OCS®) Liver (P200031/S001) | TransMedics, Inc. | 2022-09-19 |
| Coloplast Saline-Filled Testicular Prosthesis (Torosa) (P020003/S011) | Coloplast Corp. | 2022-09-16 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S268) | Medtronic Neuromodulation | 2022-09-13 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S373) | Medtronic Neuromodulation | 2022-09-13 |
| Axonics Sacral Neuromodulation System (P190006/S059) | Boston Scientific Corporation | 2022-09-08 |
| Axonics Sacral Neuromodulation System (P180046/S059) | Boston Scientific Corporation | 2022-09-08 |
| Axonics Sacral Neuromodulation System (P180046/S060) | Boston Scientific Corporation | 2022-09-07 |
| Axonics Sacral Neuromodulation System (P190006/S060) | Boston Scientific Corporation | 2022-09-07 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without lnhibiZone Treatment (N970012/S192) | Boston Scientific Corp | 2022-09-01 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone Treatment (P000053/S127) | Boston Scientific Corp | 2022-09-01 |
| Master InterStim® Therapy System, Verify® Evaluation System (P970004/S344) | Medtronic Neuromodulation | 2022-08-30 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S239) | Medtronic Neuromodulation | 2022-08-30 |
| InterStim Therapy System (P970004/S372) | Medtronic Neuromodulation | 2022-08-26 |
| LINX Reflux Management System (P100049/S029) | Torax Medical | 2022-08-26 |
| InterStim Therapy System (P080025/S267) | Medtronic Neuromodulation | 2022-08-26 |
| Coloplast Saline-Filled Testicular Prosthesis (Torosa) (P020003/S010) | Coloplast Corp. | 2022-08-24 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S062) | Coloplast Corp. | 2022-08-24 |
| Master InterStim Therapy System, Verify Evaluation System (P970004/S367) | Medtronic Neuromodulation | 2022-08-19 |
| InterStim Therapy System, Verify Evaluation System (P080025/S262) | Medtronic Neuromodulation | 2022-08-19 |
| eCoin Peripheral Neurostimulator (P200036/S001) | Boston Scientific Corporation | 2022-08-17 |
| Bulkamid Urethral Bulking System (P170023/S010) | Boston Scientific Corporation | 2022-08-05 |
| Bulkamid Urethral Bulking System (P170023/S009) | Boston Scientific Corporation | 2022-08-05 |
| Bulkamid Urethral Bulking System (P170023/S011) | Boston Scientific Corporation | 2022-08-05 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S265) | Medtronic Neuromodulation | 2022-08-04 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S370) | Medtronic Neuromodulation | 2022-08-04 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S371) | Medtronic Neuromodulation | 2022-07-28 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S266) | Medtronic Neuromodulation | 2022-07-28 |
| Axonics Sacral Neuromodulation System (P180046/S057) | Boston Scientific Corporation | 2022-07-20 |
| Axonics Sacral Neuromodulation System (P190006/S057) | Boston Scientific Corporation | 2022-07-20 |
| Obalon Balloon System (P160001/S047) | Medtimo, Inc. | 2022-07-18 |
| eCoin (Electroceutical Coin) (P200036/S003) | Boston Scientific Corporation | 2022-07-15 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S007) | Xvivo Perfusion, Inc. | 2022-07-14 |
| InterStim Therapy System (SNS Bowel Neurostimulator) (P080025/S264) | Medtronic Neuromodulation | 2022-07-08 |
| InterStim Therapy System (SNS Urinary Neurostimulator) (P970004/S369) | Medtronic Neuromodulation | 2022-07-08 |
| OrganOx metra System (P200035/S003) | Organox Limited | 2022-07-07 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment (P000053/S126) | Boston Scientific Corp | 2022-07-06 |
| LIPOSORBER LA-15 System (P910018/S034) | Kaneka Pharma America Corp. | 2022-06-30 |
| Optilume Urethral Drug Coated Balloon (P210020/S005) | Urotronic, Inc. | 2022-06-10 |
| LINX Reflux Management System (P100049/S034) | Torax Medical | 2022-06-09 |
| InterStim SNS Urinary Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (P970004/S365) | Medtronic Neuromodulation | 2022-06-09 |
| InterStim SNS Bowel Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (P080025/S260) | Medtronic Neuromodulation | 2022-06-09 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) (P970004/S366) | Medtronic Neuromodulation | 2022-06-01 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) (P080025/S261) | Medtronic Neuromodulation | 2022-06-01 |
| InterStim Therapy System SNS Urinary Neurostimulator (P970004/S363) | Medtronic Neuromodulation | 2022-06-01 |
| InterStim Therapy System SNS Bowel Neurostimulator (P080025/S258) | Medtronic Neuromodulation | 2022-06-01 |
| OrganOx metra® System (P200035/S002) | Organox Limited | 2022-05-27 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS (P860003/S107) | Therakos Development Limited | 2022-05-25 |
| Optilume Urethral Drug Coated Balloon (P210020/S004) | Urotronic, Inc. | 2022-05-17 |
| Axonics Sacral Neuromodulation System (P190006/S055) | Boston Scientific Corporation | 2022-05-13 |
| Axonics Sacral Neuromodulation System (P180046/S055) | Boston Scientific Corporation | 2022-05-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S257) | Medtronic Neuromodulation | 2022-05-12 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Bowel) (P080025/S251) | Medtronic Neuromodulation | 2022-05-12 |
| InterStim Therapy System, Verify Evaluation System (P970004/S362) | Medtronic Neuromodulation | 2022-05-12 |
| InterStim® Therapy System, Verify® Evaluation System (SNS Urinary) (P970004/S356) | Medtronic Neuromodulation | 2022-05-12 |
| InterStim Therapy System, Verify Evaluation System (P080025/S256) | Medtronic Neuromodulation | 2022-05-10 |
| InterStim Therapy System, Verify Evaluation System (P970004/S361) | Medtronic Neuromodulation | 2022-05-10 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S009) | Xvivo Perfusion, Inc. | 2022-05-09 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S008) | Xvivo Perfusion, Inc. | 2022-05-09 |
| Organ Care System (OCS) Lung System (P160013/S009) | TransMedics, Inc. | 2022-05-06 |
| LIPOSORBER LA-15 System (P910018/S033) | Kaneka Pharma America Corp. | 2022-04-29 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S360) | Medtronic Neuromodulation | 2022-04-26 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S255) | Medtronic Neuromodulation | 2022-04-26 |
| Axonics Sacral Neuromodulation System (P180046/S052) | Boston Scientific Corporation | 2022-04-20 |
| Axonics Sacral Neuromodulation System (P190006/S052) | Boston Scientific Corporation | 2022-04-20 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S191) | Boston Scientific Corp | 2022-04-20 |