| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S125) | Boston Scientific Corp | 2022-04-20 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S061) | Coloplast Corp. | 2022-04-15 |
| InterStim Therapy System (SNS Bowel Neurostimulators Implantable InterStim) (P080025/S254) | Medtronic Neuromodulation | 2022-04-15 |
| InterStim Therapy System (SNS Urinary Neurostimulator Implantable InterStim) (P970004/S359) | Medtronic Neuromodulation | 2022-04-15 |
| OrganOx metra® System (P200035/S001) | Organox Limited | 2022-04-12 |
| Gambro Prismaflex TPE 2000 Set (P830063/S023) | Vantive US Healthcare, LLC | 2022-04-07 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S124) | Boston Scientific Corp | 2022-04-01 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S190) | Boston Scientific Corp | 2022-04-01 |
| PRISMAFLEX TPE2000 SET (P830063/S022) | Vantive US Healthcare, LLC | 2022-03-31 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S357) | Medtronic Neuromodulation | 2022-03-30 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S252) | Medtronic Neuromodulation | 2022-03-30 |
| SOLESTA Injectable Gel (P100014/S032) | Palette Life Sciences | 2022-03-22 |
| DEFLUX Injectable Gel (P000029/S094) | Palette Life Sciences | 2022-03-22 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S247) | Medtronic Neuromodulation | 2022-03-18 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S352) | Medtronic Neuromodulation | 2022-03-18 |
| Solesta Injectable Gel (P100014/S033) | Palette Life Sciences | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| DEFLUX Injectable Gel (P000029/S095) | Palette Life Sciences | 2022-03-17 |
| InterStim Therapy System, Verify Evaluation System (P080025/S253) | Medtronic Neuromodulation | 2022-03-17 |
| InterStim Therapy System, Verify Evaluation System (P970004/S358) | Medtronic Neuromodulation | 2022-03-17 |
| InterStim® Therapy System, Verify® Evaluation System. (P080025/S238) | Medtronic Neuromodulation | 2022-03-16 |
| InterStim® Therapy System, Verify® Evaluation System. (P970004/S343) | Medtronic Neuromodulation | 2022-03-16 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO (P860003/S106) | Therakos Development Limited | 2022-03-11 |
| Axonics Sacral Neuromodulation System (P180046/S038) | Boston Scientific Corporation | 2022-03-07 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S123) | Boston Scientific Corp | 2022-03-07 |
| Axonics Sacral Neuromodulation System (P190006/S038) | Boston Scientific Corporation | 2022-03-07 |
| Axonics Sacral Neuromodulation System (P180046/S051) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P190006/S046) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P180046/S046) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P190006/S051) | Boston Scientific Corporation | 2022-03-03 |
| eCoin Peripheral Neurostimulator (P200036) | Boston Scientific Corporation | 2022-03-01 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S249) | Medtronic Neuromodulation | 2022-02-26 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S354) | Medtronic Neuromodulation | 2022-02-26 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S250) | Medtronic Neuromodulation | 2022-02-25 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S355) | Medtronic Neuromodulation | 2022-02-25 |
| InterStim Therapy System (P970004/S340) | Medtronic Neuromodulation | 2022-02-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S240) | Medtronic Neuromodulation | 2022-02-22 |
| InterStim Therapy System (P080025/S235) | Medtronic Neuromodulation | 2022-02-22 |
| Master InterStim® Therapy System, Verify® Evaluation System (P970004/S345) | Medtronic Neuromodulation | 2022-02-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S342) | Medtronic Neuromodulation | 2022-02-18 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S237) | Medtronic Neuromodulation | 2022-02-18 |
| Axonics Sacral Neuromodulation System (P190006/S050) | Boston Scientific Corporation | 2022-02-10 |
| Axonics Sacral Neuromodulation System (P180046/S050) | Boston Scientific Corporation | 2022-02-10 |
| Plasmaflo OP-05W (A) (P820033/S015) | Asahi Kasei Medical Co., Ltd. | 2022-02-08 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| Optilume Urethral Drug Coated Balloon (P210020/S003) | Urotronic, Inc. | 2022-02-03 |
| Axonics Sacral Neuromodulation System (P180046/S044) | Boston Scientific Corporation | 2022-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S044) | Boston Scientific Corporation | 2022-02-01 |
| Optilume Urethral Drug Coated Balloon (P210020/S002) | Urotronic, Inc. | 2022-01-27 |
| Gambro Prismaflex TPE 2000 Set (P830063/S020) | Vantive US Healthcare, LLC | 2022-01-27 |
| Axonics Sacral Neuromodulation System (P180046/S049) | Boston Scientific Corporation | 2022-01-25 |
| Axonics Sacral Neuromodulation System (P190006/S049) | Boston Scientific Corporation | 2022-01-25 |
| Optilume Urethral Drug Coated Balloon (P210020/S001) | Urotronic, Inc. | 2022-01-19 |
| Axonics Sacral Neuromodulation System (P190006/S047) | Boston Scientific Corporation | 2022-01-14 |
| LIPOSORBER LA-15 System (P910018/S032) | Kaneka Pharma America Corp. | 2022-01-14 |
| Axonics Sacral Neuromodulation System (P180046/S047) | Boston Scientific Corporation | 2022-01-14 |
| InterStim® Therapy System (P080025/S246) | Medtronic Neuromodulation | 2022-01-13 |
| Master InterStim® Therapy System (P970004/S351) | Medtronic Neuromodulation | 2022-01-13 |
| LINX Reflux Management System (P100049/S030) | Torax Medical | 2022-01-07 |
| LINX Reflux Management System (P100049/S031) | Torax Medical | 2022-01-07 |
| LINX Reflux Management System (P100049/S032) | Torax Medical | 2022-01-07 |
| Axonics Sacral Neuromodulation System (P180046/S041) | Boston Scientific Corporation | 2022-01-04 |
| Axonics Sacral Neuromodulation System (P190006/S041) | Boston Scientific Corporation | 2022-01-04 |
| Axonics Sacral Neuromodulation System (P190006/S045) | Boston Scientific Corporation | 2021-12-28 |
| Axonics Sacral Neuromodulation System (P180046/S045) | Boston Scientific Corporation | 2021-12-28 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S060) | Coloplast Corp. | 2021-12-22 |
| ORBERA® Intragastric Balloon (IGB) System (P140008/S023) | Boston Scientific Corporation | 2021-12-21 |
| InterStim® Therapy System, Verify® Evaluation System, InterStim Micro Implantable Neurostimulator (P080025/S243) | Medtronic Neuromodulation | 2021-12-15 |
| InterStim® Therapy System, Verify® Evaluation System, InterStim Micro Implantable Neurostimulator (P970004/S348) | Medtronic Neuromodulation | 2021-12-15 |
| OrganOx metra System (P200035) | Organox Limited | 2021-12-09 |
| Master InterStim Therapy System, Verify Evaluation System (P970004/S349) | Medtronic Neuromodulation | 2021-12-08 |
| InterStim Therapy System, Verify Evaluation System (P080025/S244) | Medtronic Neuromodulation | 2021-12-08 |
| InterStim Therapy System, Verify Evaluation System (P970004/S346) | Medtronic Neuromodulation | 2021-12-03 |
| Optilume Urethral Drug Coated Balloon (P210020) | Urotronic, Inc. | 2021-12-03 |
| InterStim Therapy System, Verify Evaluation System (P080025/S241) | Medtronic Neuromodulation | 2021-12-03 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S347) | Medtronic Neuromodulation | 2021-12-01 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S242) | Medtronic Neuromodulation | 2021-12-01 |
| Axonics Sacral Neuromodulation System (P180046/S043) | Boston Scientific Corporation | 2021-11-22 |
| Axonics Sacral Neuromodulation System (P190006/S043) | Boston Scientific Corporation | 2021-11-22 |
| Axonics Sacral Neuromodulation System (P190006/S042) | Boston Scientific Corporation | 2021-11-15 |
| Axonics Sacral Neuromodulation System (P180046/S042) | Boston Scientific Corporation | 2021-11-15 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S006) | Xvivo Perfusion, Inc. | 2021-11-03 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P190006/S036) | Boston Scientific Corporation | 2021-11-03 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P180046/S036) | Boston Scientific Corporation | 2021-11-03 |
| Solesta (Injectable Gel) (P100014/S031) | Palette Life Sciences | 2021-10-27 |
| Spatz3 Adjustable Balloon System (P190012) | Spatz Fgia, Inc. | 2021-10-15 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL (P860003/S104) | Therakos Development Limited | 2021-10-01 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA (P860003/S105) | Therakos Development Limited | 2021-10-01 |
| Organ Care System (OCS) Liver (P200031) | TransMedics, Inc. | 2021-09-28 |
| Axonics Sacral Neuromodulation System (P180046/S027) | Boston Scientific Corporation | 2021-09-16 |
| Axonics Sacral Neuromodulation System (P190006/S027) | Boston Scientific Corporation | 2021-09-16 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S189) | Boston Scientific Corp | 2021-09-08 |
| InterStim Therapy System, Verify Evaluation System (P080025/S233) | Medtronic Neuromodulation | 2021-09-01 |
| InterStim Therapy System, Verify Evaluation System (P970004/S338) | Medtronic Neuromodulation | 2021-09-01 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S329) | Medtronic Neuromodulation | 2021-08-30 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S224) | Medtronic Neuromodulation | 2021-08-30 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S236) | Medtronic Neuromodulation | 2021-08-24 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S341) | Medtronic Neuromodulation | 2021-08-24 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S339) | Medtronic Neuromodulation | 2021-08-18 |