| Axonics Sacral Neuromodulation System (Bowel) (P180046/S023) | Boston Scientific Corporation | 2020-11-05 |
| Axonics Sacral Neuromodulation System (Urinary) (P190006/S023) | Boston Scientific Corporation | 2020-11-05 |
| Axonics Sacral Neuromodulation System (P180046/S022) | Boston Scientific Corporation | 2020-11-05 |
| InterStim SureScan MRI Leads (P970004/S317) | Medtronic Neuromodulation | 2020-11-04 |
| InterStim SureScan MRI Leads (P080025/S212) | Medtronic Neuromodulation | 2020-11-04 |
| InterStim Therapy System, Verify Evaluation System (P970004/S315) | Medtronic Neuromodulation | 2020-11-03 |
| InterStim Therapy System, Verify Evaluation System (P080025/S210) | Medtronic Neuromodulation | 2020-11-03 |
| AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment (N970012/S183) | Boston Scientific Corp | 2020-10-30 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S117) | Boston Scientific Corp | 2020-10-30 |
| COAPTITE Injectable Implant (P040047/S063) | Merz North America, Inc. | 2020-10-23 |
| XVIVO Perfusion System with STEEN Solution Perfusate (P180014/S005) | Xvivo Perfusion, Inc. | 2020-10-23 |
| Bulkamid Urethral Bulking System (P170023/S003) | Boston Scientific Corporation | 2020-10-22 |
| Plasmaflo OP-05W(A) (P820033/S013) | Asahi Kasei Medical Co., Ltd. | 2020-10-22 |
| ORBERA Intragastric Balloon System (P140008/S021) | Boston Scientific Corporation | 2020-10-16 |
| COAPTITE Injectable Implant (P040047/S061) | Merz North America, Inc. | 2020-10-15 |
| COAPTITE Injectable Implant (P040047/S062) | Merz North America, Inc. | 2020-10-14 |
| Axonics Sacral Neuromodulation System (P180046/S020) | Boston Scientific Corporation | 2020-10-09 |
| Solesta Injectable Gel (P100014/S026) | Palette Life Sciences | 2020-10-09 |
| Axonics Sacral Neuromodulation System (P190006/S020) | Boston Scientific Corporation | 2020-10-09 |
| COAPTITE Injectable Implant (P040047/S056) | Merz North America, Inc. | 2020-10-02 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S211) | Medtronic Neuromodulation | 2020-10-01 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S316) | Medtronic Neuromodulation | 2020-10-01 |
| Titan Inflatable Penile Prosthesis (P000006/S057) | Coloplast Corp. | 2020-10-01 |
| Axonics Sacral Neuromodulation System (P190006/S021) | Boston Scientific Corporation | 2020-09-21 |
| Axonics Sacral Neuromodulation System (P180046/S021) | Boston Scientific Corporation | 2020-09-21 |
| AMS 800 Artificial Urinary Sphincter (AUS) with InhibiZone Treatment (P000053/S116) | Boston Scientific Corp | 2020-09-17 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment (N970012/S182) | Boston Scientific Corp | 2020-09-16 |
| AMS 700 Inflatable Penile Prosthesis with and without Inhibizone Treatment (N970012/S181) | Boston Scientific Corp | 2020-09-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S209) | Medtronic Neuromodulation | 2020-09-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S314) | Medtronic Neuromodulation | 2020-09-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S313) | Medtronic Neuromodulation | 2020-09-06 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S208) | Medtronic Neuromodulation | 2020-09-06 |
| AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment (N970012/S180) | Boston Scientific Corp | 2020-09-04 |
| Axonics Sacral Neuromodulation System (P180046/S015) | Boston Scientific Corporation | 2020-08-31 |
| Axonics Sacral Neuromodulation System (P190006/S015) | Boston Scientific Corporation | 2020-08-31 |
| Gambro Prismaflex TPE2000 Set (P830063/S017) | Vantive US Healthcare, LLC | 2020-08-27 |
| AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment (P000053/S115) | Boston Scientific Corp | 2020-08-26 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S022) | KARL STORZ Endoscopy-America, Inc. | 2020-08-17 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S023) | KARL STORZ Endoscopy-America, Inc. | 2020-08-17 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S024) | KARL STORZ Endoscopy-America, Inc. | 2020-08-17 |
| Therakos CELLEX Photopheresis System (P860003/S102) | Therakos Development Limited | 2020-07-31 |
| AMS 800 Artificial Urinary Sphincter (P000053/S114) | Boston Scientific Corp | 2020-07-30 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) (P080025/S197) | Medtronic Neuromodulation | 2020-07-30 |
| AMS 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis (N970012/S179) | Boston Scientific Corp | 2020-07-30 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S302) | Medtronic Neuromodulation | 2020-07-30 |
| KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System (P050027/S025) | KARL STORZ Endoscopy-America, Inc. | 2020-07-29 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S019) | Boston Scientific Corporation | 2020-07-28 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S019) | Boston Scientific Corporation | 2020-07-28 |
| Axonics Sacral Neuromodulation System (P190006/S014) | Boston Scientific Corporation | 2020-07-21 |
| Axonics Sacral Neuromodulation System (P180046/S013) | Boston Scientific Corporation | 2020-07-21 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S054) | Coloplast Corp. | 2020-07-10 |
| Axonics Sacral Neuromodulation System (P190006/S017) | Boston Scientific Corporation | 2020-07-10 |
| Axonics Sacral Neuromodulation System (P180046/S017) | Boston Scientific Corporation | 2020-07-10 |
| DEFLUX Injectable Gel (P000029/S089) | Palette Life Sciences | 2020-07-09 |
| Solesta Injectable Gel (P100014/S027) | Palette Life Sciences | 2020-07-09 |
| Axonics Sacral Neuromodulation System (P190006/S018) | Boston Scientific Corporation | 2020-07-08 |
| Axonics Sacral Neuromodulation System (P180046/S018) | Boston Scientific Corporation | 2020-07-08 |
| Axonics SNM System (P190006/S016) | Boston Scientific Corporation | 2020-07-02 |
| Axonics SNM System (P180046/S016) | Boston Scientific Corporation | 2020-07-02 |
| Axonics Sacral Neuromodulation System (P190006/S011) | Boston Scientific Corporation | 2020-07-01 |
| Axonics Sacral Neuromodulation System (P180046/S011) | Boston Scientific Corporation | 2020-07-01 |
| LINX Reflux Management System (P100049/S027) | Torax Medical | 2020-06-29 |
| AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S113) | Boston Scientific Corp | 2020-06-16 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S178) | Boston Scientific Corp | 2020-06-16 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S206) | Medtronic Neuromodulation | 2020-06-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S311) | Medtronic Neuromodulation | 2020-06-09 |
| KARL STORZ Photodynamic D-Light C PDD System (P050027/S021) | KARL STORZ Endoscopy-America, Inc. | 2020-06-05 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S056) | Coloplast Corp. | 2020-06-05 |
| Axonics Sacral Neuromodulation System (P190006/S006) | Boston Scientific Corporation | 2020-06-02 |
| Bulkamid Urethral Bulking System (P170023/S001) | Boston Scientific Corporation | 2020-06-02 |
| Axonics Sacral Neuromodulation System (P180046/S006) | Boston Scientific Corporation | 2020-06-02 |
| PRISMAFLEX TPE 2000 Set (P830063/S016) | Vantive US Healthcare, LLC | 2020-05-23 |
| AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S177) | Boston Scientific Corp | 2020-05-20 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S112) | Boston Scientific Corp | 2020-05-20 |
| COAPTITE Injectable Implant (P040047/S058) | Merz North America, Inc. | 2020-05-18 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S205) | Medtronic Neuromodulation | 2020-05-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S310) | Medtronic Neuromodulation | 2020-05-08 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S309) | Medtronic Neuromodulation | 2020-05-07 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S204) | Medtronic Neuromodulation | 2020-05-07 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S004) | Xvivo Perfusion, Inc. | 2020-04-26 |
| Xvivo Perfusion System (XPS) with Steen Solution Perfusate (P180014/S003) | Xvivo Perfusion, Inc. | 2020-04-24 |
| Pathway Clinical Trial Cohort (P150024/S016) | Aspire Bariatrics, Inc. | 2020-04-24 |
| LIPOSORBER LA-15 System (P910018/S027) | Kaneka Pharma America Corp. | 2020-04-21 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S004) | Boston Scientific Corporation | 2020-04-19 |
| COAPTITE Injectable Implant (P040047/S057) | Merz North America, Inc. | 2020-04-15 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S001) | Boston Scientific Corporation | 2020-04-15 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S002) | Boston Scientific Corporation | 2020-04-15 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S004) | Boston Scientific Corporation | 2020-04-13 |
| Axonics Sacral Neuromodulation System (P190006/S010) | Boston Scientific Corporation | 2020-04-10 |
| Axonics Sacral Neuromodulation System (P180046/S010) | Boston Scientific Corporation | 2020-04-10 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis with and without InhibiZone Treatment (N970012/S176) | Boston Scientific Corp | 2020-04-09 |
| Axonics Sacral Neuromodulation System (P190006/S009) | Boston Scientific Corporation | 2020-04-07 |
| Axonics Sacral Neuromodulation System (P180046/S009) | Boston Scientific Corporation | 2020-04-07 |
| Axonics Sacral Neuromodulation System (P190006/S008) | Boston Scientific Corporation | 2020-04-03 |
| Axonics Sacral Neuromodulation System (P180046/S007) | Boston Scientific Corporation | 2020-04-03 |
| Axonics Sacral Neuromodulation System (P180046/S008) | Boston Scientific Corporation | 2020-04-03 |
| Axonics Sacral Neuromodulation System (P190006/S007) | Boston Scientific Corporation | 2020-04-03 |
| Obalon Balloon System (P160001/S046) | Medtimo, Inc. | 2020-03-30 |
| Prismaflex TPE2000 Set (P830063/S015) | Vantive US Healthcare, LLC | 2020-03-25 |
| KARL STORZ Photodynamic Diagnostic D-Light C System (P050027/S020) | KARL STORZ Endoscopy-America, Inc. | 2020-03-25 |