| InterStim® Therapy System, Verify® Evaluation System (P080025/S234) | Medtronic Neuromodulation | 2021-08-18 |
| lnterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S337) | Medtronic Neuromodulation | 2021-08-13 |
| lnterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S232) | Medtronic Neuromodulation | 2021-08-13 |
| ORBERA Intragastric Balloon (IGB) System (P140008/S022) | Boston Scientific Corporation | 2021-08-12 |
| LIPOSORBER LA-15 System (P910018/S029) | Kaneka Pharma America Corp. | 2021-08-06 |
| Organ Care System (OCS) Lung System (P160013/S008) | TransMedics, Inc. | 2021-08-02 |
| LIPOSORBER LA-15 System (P910018/S031) | Kaneka Pharma America Corp. | 2021-07-28 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S335) | Medtronic Neuromodulation | 2021-07-21 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S230) | Medtronic Neuromodulation | 2021-07-21 |
| Prismaflex TPE2000 Set (P830063/S018) | Vantive US Healthcare, LLC | 2021-07-16 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S336) | Medtronic Neuromodulation | 2021-07-15 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S231) | Medtronic Neuromodulation | 2021-07-15 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S188) | Boston Scientific Corp | 2021-07-08 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment (P000053/S121) | Boston Scientific Corp | 2021-07-08 |
| ProstaLund CoreTherm System Microwave Thermotherapy for BPH (P010055/S011) | Prostalund AB | 2021-06-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S334) | Medtronic Neuromodulation | 2021-06-25 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S229) | Medtronic Neuromodulation | 2021-06-25 |
| Prismaflex TPE2000 Set (P830063/S019) | Vantive US Healthcare, LLC | 2021-06-24 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S228) | Medtronic Neuromodulation | 2021-06-22 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S333) | Medtronic Neuromodulation | 2021-06-22 |
| Axonics Sacral Neuromodulation System (P180046/S025) | Boston Scientific Corporation | 2021-06-11 |
| Axonics Sacral Neuromodulation System (P190006/S025) | Boston Scientific Corporation | 2021-06-11 |
| ProACT Adjustable Continence Therapy for Men (P130018/S002) | Uromedica, Inc. | 2021-06-10 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S187) | Boston Scientific Corp | 2021-05-27 |
| AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S120) | Boston Scientific Corp | 2021-05-27 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S186) | Boston Scientific Corp | 2021-05-26 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P180046/S037) | Boston Scientific Corporation | 2021-05-25 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P190006/S037) | Boston Scientific Corporation | 2021-05-25 |
| Axonics Sacral Neuromodulation System (P180046/S024) | Boston Scientific Corporation | 2021-05-19 |
| Axonics Sacral Neuromodulation System (P190006/S024) | Boston Scientific Corporation | 2021-05-19 |
| DEFLUX Injectable Gel (P000029/S087) | Palette Life Sciences | 2021-05-03 |
| Solesta Injectable Gel (P100014/S024) | Palette Life Sciences | 2021-05-03 |
| LIPOSORBER® LA-15 System (P910018/S030) | Kaneka Pharma America Corp. | 2021-04-29 |
| InterStim Therapy System, Verify Evaluation System (P080025/S223) | Medtronic Neuromodulation | 2021-04-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S332) | Medtronic Neuromodulation | 2021-04-09 |
| InterStim Therapy System and Veify Evaluation System (SNS Bowel Programming Systems) (P080025/S227) | Medtronic Neuromodulation | 2021-04-09 |
| InterStim Therapy System, Verify Evaluation System (P970004/S328) | Medtronic Neuromodulation | 2021-04-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S331) | Medtronic Neuromodulation | 2021-04-06 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S226) | Medtronic Neuromodulation | 2021-04-06 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S225) | Medtronic Neuromodulation | 2021-03-31 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S330) | Medtronic Neuromodulation | 2021-03-31 |
| Axonics Sacral Neuromodulation (SNM) System Bowel Control (P190006/S034) | Boston Scientific Corporation | 2021-03-25 |
| Axonics Sacral Neuromodulation (SNM) System Urinary Control (P180046/S034) | Boston Scientific Corporation | 2021-03-25 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S033) | Boston Scientific Corporation | 2021-03-16 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S033) | Boston Scientific Corporation | 2021-03-16 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S185) | Boston Scientific Corp | 2021-03-16 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S032) | Boston Scientific Corporation | 2021-03-04 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S032) | Boston Scientific Corporation | 2021-03-04 |
| Plasmaflo OP-05W(A) (P820033/S014) | Asahi Kasei Medical Co., Ltd. | 2021-03-03 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S031) | Boston Scientific Corporation | 2021-03-02 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S031) | Boston Scientific Corporation | 2021-03-02 |
| Axonics Sacral Neuromodulation (SNM) System Urinary Control (P190006/S030) | Boston Scientific Corporation | 2021-03-01 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S030) | Boston Scientific Corporation | 2021-03-01 |
| Durasphere Injectable Bulking Agent (P980053/S018) | Carbon Medical Technologies, Inc. | 2021-02-25 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S029) | Boston Scientific Corporation | 2021-02-24 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S029) | Boston Scientific Corporation | 2021-02-23 |
| Prismaflex TPE2000 Set (P830063/S013) | Vantive US Healthcare, LLC | 2021-02-12 |
| Axonics Sacral Neuromodulation System (P180046/S026) | Boston Scientific Corporation | 2021-02-03 |
| Axonics Sacral Neuromodulation System (P190006/S026) | Boston Scientific Corporation | 2021-02-03 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems) (P080025/S217) | Medtronic Neuromodulation | 2021-02-02 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S322) | Medtronic Neuromodulation | 2021-02-02 |
| Bulkamid Urethral Bulking System (P170023/S008) | Boston Scientific Corporation | 2021-01-14 |
| Titan Inflatable Penile Prosthesis (P000006/S059) | Coloplast Corp. | 2021-01-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S327) | Medtronic Neuromodulation | 2021-01-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S222) | Medtronic Neuromodulation | 2021-01-08 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |
| KARL STORZ Photodynamic Diagnostic (PDD) D-Light System (P050027/S026) | KARL STORZ Endoscopy-America, Inc. | 2021-01-06 |
| LIPOSORBER LA-15 System (P910018/S028) | Kaneka Pharma America Corp. | 2020-12-22 |
| InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Urinary) (P970004/S325) | Medtronic Neuromodulation | 2020-12-18 |
| DEFLUX Injectable Gel (P000029/S093) | Palette Life Sciences | 2020-12-18 |
| InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Bowel) (P080025/S220) | Medtronic Neuromodulation | 2020-12-18 |
| Solesta Injectable Gel (P100014/S030) | Palette Life Sciences | 2020-12-18 |
| 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis (N970012/S184) | Boston Scientific Corp | 2020-12-17 |
| AMS 800 Artificial Urinary Sphincter (P000053/S119) | Boston Scientific Corp | 2020-12-17 |
| Bulkamid Urethral Bulking System (P170023/S007) | Boston Scientific Corporation | 2020-12-17 |
| InterStim Therapy System and Verify Evaluation System (P080025/S221) | Medtronic Neuromodulation | 2020-12-16 |
| InterStim SureScan MRI Leads and Percutaneous Extensions (P970004/S324) | Medtronic Neuromodulation | 2020-12-16 |
| InterStim Therapy System and Verify Evaluation System (P970004/S326) | Medtronic Neuromodulation | 2020-12-16 |
| InterStim SureScan MRI Leads and Percutaneous Extensions (P080025/S219) | Medtronic Neuromodulation | 2020-12-16 |
| InterStim SureScan MRI Leads (P970004/S323) | Medtronic Neuromodulation | 2020-12-16 |
| InterStim SureScan MRI Leads (P080025/S218) | Medtronic Neuromodulation | 2020-12-16 |
| DEFLUX Injectable Gel (P000029/S092) | Palette Life Sciences | 2020-12-11 |
| Solesta Injectable Gel (P100014/S029) | Palette Life Sciences | 2020-12-11 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment (P000053/S118) | Boston Scientific Corp | 2020-12-11 |
| Titan Inflatable Penile Prosthesis (P000006/S058) | Coloplast Corp. | 2020-12-07 |
| Organ Care System (OCS) Lung System (P160013/S007) | TransMedics, Inc. | 2020-12-03 |
| ORBERA Intragastric Balloon System (P140008/S019) | Boston Scientific Corporation | 2020-12-02 |
| Bulkamid Urethral Bulking System (P170023/S005) | Boston Scientific Corporation | 2020-12-02 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S321) | Medtronic Neuromodulation | 2020-11-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P080025/S216) | Medtronic Neuromodulation | 2020-11-30 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Urinary) (P970004/S320) | Medtronic Neuromodulation | 2020-11-19 |
| InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel) (P080025/S215) | Medtronic Neuromodulation | 2020-11-19 |
| Deflux Injectable Gel (P000029/S091) | Palette Life Sciences | 2020-11-18 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S319) | Medtronic Neuromodulation | 2020-11-12 |
| Deflux Injectable Gel (P000029/S090) | Palette Life Sciences | 2020-11-12 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S214) | Medtronic Neuromodulation | 2020-11-12 |
| InterStim Therapy System, Verify Evaluation System (P970004/S318) | Medtronic Neuromodulation | 2020-11-12 |
| Solesta Injectable Gel (P100014/S028) | Palette Life Sciences | 2020-11-12 |
| InterStim Therapy System, Verify Evaluation System (P080025/S213) | Medtronic Neuromodulation | 2020-11-12 |
| Axonics Sacral Neuromodulation System (P190006/S022) | Boston Scientific Corporation | 2020-11-05 |