| 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 |
| Axonics Sacral Neuromodulation System (P180046/S086) | Boston Scientific Corporation | 2024-07-25 |
| Axonics Sacral Neuromodulation System (P190006/S086) | Boston Scientific Corporation | 2024-07-25 |
| Axonics Sacral Neuromodulation System (P190006/S085) | Boston Scientific Corporation | 2024-07-16 |
| Axonics Sacral Neuromodulation System (P180046/S085) | Boston Scientific Corporation | 2024-07-16 |
| COAPTITE Injectable Implant (P040047/S075) | Merz North America, Inc. | 2024-07-10 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S068) | Coloplast Corp. | 2024-07-09 |
| InterStim Therapy System, Verify Evaluation System (P970004/S402) | Medtronic Neuromodulation | 2024-07-05 |
| InterStim Therapy System, Verify Evaluation System (P080025/S297) | Medtronic Neuromodulation | 2024-07-05 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S401) | Medtronic Neuromodulation | 2024-06-28 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S296) | Medtronic Neuromodulation | 2024-06-28 |
| Plasmaflo OP-05W(A) (P820033/S018) | Asahi Kasei Medical Co., Ltd. | 2024-06-18 |
| InterStim Therapy System, Verify Evaluation System (P970004/S397) | Medtronic Neuromodulation | 2024-06-11 |
| InterStim Therapy System, Verify Evaluation System (P080025/S292) | Medtronic Neuromodulation | 2024-06-11 |
| ORBERA Intragastric Balloon (P140008/S026) | Boston Scientific Corporation | 2024-05-31 |
| Deflux® Injectable Gel (P000029/S098) | Palette Life Sciences | 2024-05-31 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S204) | Boston Scientific Corp | 2024-05-30 |
| AMS 700 Inflatable Penile Prosthesis without InhibiZone (N970012/S203) | Boston Scientific Corp | 2024-05-29 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone (P000053/S135) | Boston Scientific Corp | 2024-05-29 |
| AMS 800 Artificial Urinary Sphincter (with InhibiZone) (P000053/S134) | Boston Scientific Corp | 2024-05-23 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S400) | Medtronic Neuromodulation | 2024-05-23 |
| AMS 700 Inflatable Penile Prosthesis (with InhibiZone) (N970012/S202) | Boston Scientific Corp | 2024-05-23 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S295) | Medtronic Neuromodulation | 2024-05-23 |
| ReShape Lap-Band Adjustable Gastric Banding System (P000008/S050) | Medtimo, Inc. | 2024-05-15 |
| InterStim Therapy System, Verify Evaluation System (P970004/S399) | Medtronic Neuromodulation | 2024-05-10 |
| Coaptite Injectable Implant (P040047/S074) | Merz North America, Inc. | 2024-05-10 |
| InterStim Therapy System, Verify Evaluation System (P080025/S294) | Medtronic Neuromodulation | 2024-05-10 |
| Axonics Sacral Neuromodulation System (P180046/S083) | Boston Scientific Corporation | 2024-05-02 |
| Axonics Sacral Neuromodulation System (P190006/S083) | Boston Scientific Corporation | 2024-05-02 |
| InterStim Therapy System, Verify Evaluation System (P080025/S293) | Medtronic Neuromodulation | 2024-04-24 |
| InterStim Therapy System, Verify Evaluation System (P970004/S398) | Medtronic Neuromodulation | 2024-04-24 |
| Axonics Sacral Neuromodulation System (P180046/S081) | Boston Scientific Corporation | 2024-04-12 |
| Axonics Sacral Neuromodulation System (P190006/S081) | Boston Scientific Corporation | 2024-04-12 |
| Axonics Sacral Neuromodulation System (P190006/S082) | Boston Scientific Corporation | 2024-04-10 |
| Axonics Sacral Neuromodulation System (P180046/S082) | Boston Scientific Corporation | 2024-04-10 |
| Axonics Sacral Neuromodulation System (P180046/S077) | Boston Scientific Corporation | 2024-04-01 |
| Axonics Sacral Neuromodulation System (P190006/S077) | Boston Scientific Corporation | 2024-04-01 |
| OrganOx metra® System (P200035/S014) | Organox Limited | 2024-03-28 |
| (EZW) InterStim® Therapy System, Verify® Evaluation System (P970004/S395) | Medtronic Neuromodulation | 2024-03-27 |
| (QON) InterStim® Therapy System, Verify® Evaluation System (P080025/S290) | Medtronic Neuromodulation | 2024-03-27 |
| Spatz3 Adjustable Balloon System (P190012/S004) | Spatz Fgia, Inc. | 2024-02-29 |
| Organ Care System (OCS®) Liver (P200031/S006) | TransMedics, Inc. | 2024-02-23 |
| SNS Bowel Neurostimulators Implantable InterStim (P080025/S291) | Medtronic Neuromodulation | 2024-02-22 |
| OrganOx metra System (P200035/S011) | Organox Limited | 2024-02-22 |
| LINX Reflux Management System (P100049/S037) | Torax Medical | 2024-02-22 |
| SNS Urinary Neurostimulator Implantable InterStim (P970004/S396) | Medtronic Neuromodulation | 2024-02-22 |
| Axonics Sacral Neuromodulation System (P190006/S076) | Boston Scientific Corporation | 2024-02-08 |
| Axonics Sacral Neuromodulation System (P180046/S076) | Boston Scientific Corporation | 2024-02-08 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S067) | Coloplast Corp. | 2024-02-05 |
| ReShape Lap-Band System (P000008/S049) | Medtimo, Inc. | 2024-01-26 |
| Coaptite Injectable Implant (P040047/S070) | Merz North America, Inc. | 2024-01-25 |
| Durasphere® Injectable Bulking Agent (P980053/S020) | Carbon Medical Technologies, Inc. | 2024-01-18 |
| Optilume Urethral Drug Coated Balloon catheter (P210020/S009) | Urotronic, Inc. | 2024-01-13 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S394) | Medtronic Neuromodulation | 2024-01-11 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S289) | Medtronic Neuromodulation | 2024-01-11 |
| Prismaflex TPE2000 Set (P830063/S027) | Vantive US Healthcare, LLC | 2024-01-10 |
| Organ Care System (OCS) Lung System (P160013/S016) | TransMedics, Inc. | 2024-01-09 |
| OrganOx metra® System (P200035/S013) | Organox Limited | 2024-01-03 |
| LINX Reflux Management System (P100049/S036) | Torax Medical | 2023-12-19 |
| InterStim Therapy System, Verify Evaluation System (P080025/S285) | Medtronic Neuromodulation | 2023-12-18 |
| Bulkamid Urethral Bulking System (P170023/S016) | Boston Scientific Corporation | 2023-12-18 |
| InterStim Therapy System, Verify Evaluation System (P970004/S390) | Medtronic Neuromodulation | 2023-12-18 |
| ORBERA Intragastric Balloon (IGB) System, Endoline Punc (P140008/S025) | Boston Scientific Corporation | 2023-12-14 |
| LINX Reflux Management System (P100049/S035) | Torax Medical | 2023-12-14 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S287) | Medtronic Neuromodulation | 2023-12-12 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S392) | Medtronic Neuromodulation | 2023-12-12 |
| Lap-Band Adjustable Gastric Banding System (P000008/S048) | Medtimo, Inc. | 2023-12-12 |
| AMS 700 Inflatable Penile Prosthesis (IPP (N970012/S201) | Boston Scientific Corp | 2023-12-11 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S133) | Boston Scientific Corp | 2023-12-11 |
| Solesta® Injectable Gel (P100014/S035) | Palette Life Sciences | 2023-12-07 |
| Deflux® Injectable Gel (P000029/S097) | Palette Life Sciences | 2023-12-07 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S391) | Medtronic Neuromodulation | 2023-11-29 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S286) | Medtronic Neuromodulation | 2023-11-29 |
| Axonics Sacral Neuromodulation System (P180046/S075) | Boston Scientific Corporation | 2023-11-28 |
| Axonics Sacral Neuromodulation System (P190006/S075) | Boston Scientific Corporation | 2023-11-28 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S288) | Medtronic Neuromodulation | 2023-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S385) | Medtronic Neuromodulation | 2023-11-22 |
| AMS 700 Implantable Penile Prosthesis without lnhibiZone (N970012/S200) | Boston Scientific Corp | 2023-11-22 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (P000053/S132) | Boston Scientific Corp | 2023-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S280) | Medtronic Neuromodulation | 2023-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S393) | Medtronic Neuromodulation | 2023-11-22 |
| OrganOx metra® System (P200035/S007) | Organox Limited | 2023-11-20 |