| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S308) | Medtronic Neuromodulation | 2020-03-20 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S203) | Medtronic Neuromodulation | 2020-03-20 |
| AMS 800 Series Product Line/Artifical Urinary Sphincter with and without InhibiZone Treatment (P000053/S111) | Boston Scientific Corp | 2020-03-06 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S175) | Boston Scientific Corp | 2020-03-06 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S005) | Boston Scientific Corporation | 2020-02-28 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S005) | Boston Scientific Corporation | 2020-02-28 |
| DEFLUX Injectable Gel (P000029/S088) | Palette Life Sciences | 2020-02-27 |
| Solesta Injectable Gel (P100014/S025) | Palette Life Sciences | 2020-02-27 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S174) | Boston Scientific Corp | 2020-02-21 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S292) | Medtronic Neuromodulation | 2020-02-19 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S104) | Boston Scientific Corp | 2020-02-13 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S187) | Medtronic Neuromodulation | 2020-02-13 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S163) | Boston Scientific Corp | 2020-02-13 |
| ORBERA Intragastric Balloon System (P140008/S016) | Boston Scientific Corporation | 2020-02-13 |
| Obalon Ballon System with Navigation and Touch (P160001/S044) | Medtimo, Inc. | 2020-02-11 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S307) | Medtronic Neuromodulation | 2020-02-05 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S202) | Medtronic Neuromodulation | 2020-02-05 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S003) | Boston Scientific Corporation | 2020-01-30 |
| Bulkamid Urethral Bulking System (P170023) | Boston Scientific Corporation | 2020-01-28 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S003) | Boston Scientific Corporation | 2020-01-28 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S001) | Boston Scientific Corporation | 2020-01-14 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S201) | Medtronic Neuromodulation | 2020-01-09 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S306) | Medtronic Neuromodulation | 2020-01-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S200) | Medtronic Neuromodulation | 2020-01-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S305) | Medtronic Neuromodulation | 2020-01-09 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S105) | Boston Scientific Corp | 2019-12-30 |
| AMS 700 Implantable numbera Penile Prosthesis with and without Inhibizone Treatment (N970012/S164) | Boston Scientific Corp | 2019-12-30 |
| Organ Care System (OCS) Lung System (P160013/S005) | TransMedics, Inc. | 2019-12-20 |
| Organ Care System (OCS) Lung System (P160013/S006) | TransMedics, Inc. | 2019-12-20 |
| Karl Storz Photodynamic D-light C (PDD) System (P050027/S018) | KARL STORZ Endoscopy-America, Inc. | 2019-12-20 |
| Interstim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S304) | Medtronic Neuromodulation | 2019-12-19 |
| Solesta Injectable Gel (P100014/S023) | Palette Life Sciences | 2019-12-19 |
| DEFLUX Injectable Gel (P000029/S086) | Palette Life Sciences | 2019-12-19 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S199) | Medtronic Neuromodulation | 2019-12-19 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S173) | Boston Scientific Corp | 2019-12-13 |
| Axonics Sacral Neuromodulation System (P190006/S002) | Boston Scientific Corporation | 2019-12-12 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S171) | Boston Scientific Corp | 2019-12-12 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S198) | Medtronic Neuromodulation | 2019-12-11 |
| PRISMAFLEX TPE2000 (P830063/S014) | Vantive US Healthcare, LLC | 2019-12-11 |
| AMS 800 Artificial Urinary Sphincter (P000053/S110) | Boston Scientific Corp | 2019-12-11 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone, AMS Ambicor IPP (N970012/S172) | Boston Scientific Corp | 2019-12-11 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S303) | Medtronic Neuromodulation | 2019-12-11 |
| Linx Reflux Management System (P100049/S028) | Torax Medical | 2019-12-10 |
| AMS 800 Series Product Line/Artificial Urinary sphincter with and without InhibiZone Treatment (P000053/S109) | Boston Scientific Corp | 2019-12-04 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S170) | Boston Scientific Corp | 2019-12-04 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S168) | Boston Scientific Corp | 2019-11-27 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S169) | Boston Scientific Corp | 2019-11-27 |
| AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S108) | Boston Scientific Corp | 2019-11-27 |
| InterStim Therapy System and Verify Evaluation System (P080025/S194) | Medtronic Neuromodulation | 2019-11-26 |
| InterStim Therapy System and Verify Evaluation System (P970004/S299) | Medtronic Neuromodulation | 2019-11-26 |
| LAP-BAND System (P000008/S047) | Medtimo, Inc. | 2019-11-13 |
| Axonics Sacral Neuromodulation System (P180046) | Boston Scientific Corporation | 2019-11-13 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S284) | Medtronic Neuromodulation | 2019-11-06 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S179) | Medtronic Neuromodulation | 2019-11-06 |
| Coaptite lnjectable lmplant (P040047/S055) | Merz North America, Inc. | 2019-11-06 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S001) | Xvivo Perfusion, Inc. | 2019-10-29 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S053) | Coloplast Corp. | 2019-10-25 |
| Torosa Saline Filled Testicular Prosthesis (P020003/S009) | Coloplast Corp. | 2019-10-25 |
| Obalon Balloon System (P160001/S033) | Medtimo, Inc. | 2019-10-18 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S301) | Medtronic Neuromodulation | 2019-10-13 |
| Interm Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S196) | Medtronic Neuromodulation | 2019-10-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S195) | Medtronic Neuromodulation | 2019-10-10 |
| Interstim Therapy System, Verify Evaluation System (P970004/S300) | Medtronic Neuromodulation | 2019-10-10 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S298) | Medtronic Neuromodulation | 2019-09-27 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S193) | Medtronic Neuromodulation | 2019-09-27 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone, and the AMS Ambicor Inflatable Penile Prosthesis (P000053/S107) | Boston Scientific Corp | 2019-09-20 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S167) | Boston Scientific Corp | 2019-09-20 |
| Prismaflex TPE2000 Set (P830063/S012) | Vantive US Healthcare, LLC | 2019-09-18 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S297) | Medtronic Neuromodulation | 2019-09-17 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S192) | Medtronic Neuromodulation | 2019-09-17 |
| InterStim Therapy System, Verify Evaluation System (P970004/S294) | Medtronic Neuromodulation | 2019-09-11 |
| InterStim Therapy System, Verify Evaluation System (P080025/S189) | Medtronic Neuromodulation | 2019-09-11 |
| Axonics Sacral Neuromodulation System (P190006) | Boston Scientific Corporation | 2019-09-06 |
| Titan Inflatable Penile Prosthesis (P000006/S051) | Coloplast Corp. | 2019-09-05 |
| AMS 700 Inflatable Penile Prosthesis, and AMS Ambicor Inflatable Penile Prosthesis (N970012/S166) | Boston Scientific Corp | 2019-08-30 |
| AMS 800 Artificial Urinary Sphincter (P000053/S106) | Boston Scientific Corp | 2019-08-30 |
| Deflux Injectable Gel (P000029/S085) | Palette Life Sciences | 2019-08-29 |
| Solesta Injectable Gel (P100014/S022) | Palette Life Sciences | 2019-08-29 |
| Durasphere Injectable Bulking Agent (P980053/S017) | Carbon Medical Technologies, Inc. | 2019-08-29 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S296) | Medtronic Neuromodulation | 2019-08-22 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S191) | Medtronic Neuromodulation | 2019-08-22 |
| Titan Inflatable Penile Prosthesis (P000006/S052) | Coloplast Corp. | 2019-08-21 |
| Obalon Touch Dispenser (P160001/S039) | Medtimo, Inc. | 2019-08-20 |
| InterStim Therapy System, Verify Evaluation System (P080025/S190) | Medtronic Neuromodulation | 2019-08-14 |
| InterStim Therapy System, Verify Evaluation System (P970004/S295) | Medtronic Neuromodulation | 2019-08-14 |
| Obalon Balloon System (P160001/S042) | Medtimo, Inc. | 2019-08-08 |
| Obalon Touch Dispenser (P160001/S043) | Medtimo, Inc. | 2019-07-25 |
| KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System (P050027/S019) | KARL STORZ Endoscopy-America, Inc. | 2019-07-25 |
| InterStim Therapy System and Verify Evaluation System (SNM Urinary) (P970004/S293) | Medtronic Neuromodulation | 2019-07-25 |
| InterStim Therapy System and Verify Evaluation System (SNM Urinary and Bowel) (P080025/S188) | Medtronic Neuromodulation | 2019-07-25 |
| ORBERA Intragastric Balloon System (P140008/S018) | Boston Scientific Corporation | 2019-07-19 |
| Macroplastique Implants (P040050/S012) | Uroplasty, LLC | 2019-07-15 |
| LINX Reflux Mnagement System (P100049/S026) | Torax Medical | 2019-07-15 |
| AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S165) | Boston Scientific Corp | 2019-07-11 |
| Obalon Balloon System with Navigation and Touch (P160001/S031) | Medtimo, Inc. | 2019-07-05 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S186) | Medtronic Neuromodulation | 2019-07-05 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S291) | Medtronic Neuromodulation | 2019-07-05 |
| Obalon Touch Dispenser (P160001/S040) | Medtimo, Inc. | 2019-07-03 |
| Obalon Balloon Kit, Obalon Navigation Balloon Kit, and Obalon Touch Balloon Kit (P160001/S041) | Medtimo, Inc. | 2019-07-03 |
| Coaptite (P040047/S052) | Merz North America, Inc. | 2019-06-26 |