| H.E.L.P. Futura Apheresis System (P940016/S027) | B. Braun Avitum AG | 2019-06-07 |
| Coaptite Injectable Implant (P040047/S054) | Merz North America, Inc. | 2019-06-07 |
| Coaptite Injectable Implant (P040047/S053) | Merz North America, Inc. | 2019-06-07 |
| ORBERA Intragastric Balloon System (P140008/S017) | Boston Scientific Corporation | 2019-06-03 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S185) | Medtronic Neuromodulation | 2019-06-03 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S290) | Medtronic Neuromodulation | 2019-06-03 |
| Organ Care System (OCS) Lung System (P160013/S002) | TransMedics, Inc. | 2019-05-31 |
| OBALON BALLOON SYSTEM (P160001/S038) | Medtimo, Inc. | 2019-05-29 |
| SNS Bowel: InterStim Therapy System and Verify Evaluation System (P080025/S184) | Medtronic Neuromodulation | 2019-05-24 |
| SNS Urinary: InterStim Therapy System and Verify Evaluation System (P970004/S289) | Medtronic Neuromodulation | 2019-05-24 |
| SNS Bowel InterStim Therapy System and Verify Evaluation System (P080025/S183) | Medtronic Neuromodulation | 2019-05-23 |
| SNS Urinary interStim Therapy System and Verify Evaluation System (P970004/S288) | Medtronic Neuromodulation | 2019-05-23 |
| LIPOSORBER LA-15 System (P910018/S026) | Kaneka Pharma America Corp. | 2019-05-22 |
| Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S026) | B. Braun Avitum AG | 2019-05-22 |
| InterStim Therapy System, Verify Evaluation System (Bowel Neurostimulators) (P080025/S182) | Medtronic Neuromodulation | 2019-05-17 |
| InterStim Therapy System, Verify Evaluation System (Urinary Neurostimulator) (P970004/S287) | Medtronic Neuromodulation | 2019-05-17 |
| Obalon Navigation Balloon Kit (P160001/S037) | Medtimo, Inc. | 2019-05-16 |
| InterStim Therapy System, Verify Evaluation System (P080025/S158) | Medtronic Neuromodulation | 2019-05-15 |
| InterStim Therapy System, Verify Evaluation System (P970004/S263) | Medtronic Neuromodulation | 2019-05-15 |
| Therakos CELLEX Procedural Kit (P860003/S101) | Therakos Development Limited | 2019-05-13 |
| AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Penile Prosthesis (N970012/S157) | Boston Scientific Corp | 2019-05-06 |
| AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Penile Prosthesis (N970012/S158) | Boston Scientific Corp | 2019-05-06 |
| AMS 800 Artifical Urinary Sphinchter (P000053/S101) | Boston Scientific Corp | 2019-05-06 |
| AMS 800 Artificial Urinary Sphincter (P000053/S100) | Boston Scientific Corp | 2019-05-06 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S045) | Medtimo, Inc. | 2019-05-02 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S181) | Medtronic Neuromodulation | 2019-05-01 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S286) | Medtronic Neuromodulation | 2019-05-01 |
| Obalon Touch Dispenser (P160001/S036) | Medtimo, Inc. | 2019-04-26 |
| XPS with Steen Solution Perfusate (P180014) | Xvivo Perfusion, Inc. | 2019-04-26 |
| KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System (P050027/S017) | KARL STORZ Endoscopy-America, Inc. | 2019-04-22 |
| AMS 700 Series Product Line/ Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S162) | Boston Scientific Corp | 2019-04-18 |
| TransPyloric Shuttle/TransPyloric Shuttle Delivery Device (P180024) | Baronova, Inc. | 2019-04-16 |
| Obalon Navigation Balloon Kit (P160001/S035) | Medtimo, Inc. | 2019-04-12 |
| AMS Ambicor Inflatable Penile Prosthesis (N970012/S160) | Boston Scientific Corp | 2019-04-03 |
| InterStim Therapy System Verify Evaluation System (SNS Bowel) (P080025/S180) | Medtronic Neuromodulation | 2019-04-02 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S285) | Medtronic Neuromodulation | 2019-04-02 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S150) | Boston Scientific Corp | 2019-04-01 |
| AMS 800 Artificial Urinary Sphincter with and without Inhibizone Treatment (P000053/S102) | Boston Scientific Corp | 2019-03-29 |
| AMS Ambicor Inflatable Penile Prosthesis (N970012/S161) | Boston Scientific Corp | 2019-03-28 |
| AMS 800 Artificial Urinary Sphincter (with and without InhibiZone); AMS 700 Inflatable Penile Prosthesis (with and witho (P000053/S103) | Boston Scientific Corp | 2019-03-28 |
| LIPOSORBER LA-15 System (P910018/S023) | Kaneka Pharma America Corp. | 2019-03-28 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S159) | Boston Scientific Corp | 2019-03-27 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S283) | Medtronic Neuromodulation | 2019-03-22 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S178) | Medtronic Neuromodulation | 2019-03-22 |
| InterStim Therapy System, Verify Evaluation System (P080025/S177) | Medtronic Neuromodulation | 2019-03-08 |
| InterStim Therapy System, Verify Evaluation System (P970004/S282) | Medtronic Neuromodulation | 2019-03-08 |
| Obalon Balloon System with Navigation and Touch (P160001/S032) | Medtimo, Inc. | 2019-03-01 |
| KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM (P050027/S014) | KARL STORZ Endoscopy-America, Inc. | 2019-02-21 |
| MAS 700 Inflatable Penile PRosthesis (IP) with and without InhibiZone (N970012/S155) | Boston Scientific Corp | 2019-02-15 |
| Maestro Rechargeable System (P130019/S019) | Reshape Lifesciences, Inc. | 2019-02-15 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S156) | Boston Scientific Corp | 2019-02-15 |
| Obalon Balloon System (P160001/S030) | Medtimo, Inc. | 2019-02-14 |
| Maestro Rechargeable System (P130019/S017) | Reshape Lifesciences, Inc. | 2019-01-25 |
| Obalon Balloon System (P160001/S021) | Medtimo, Inc. | 2019-01-25 |
| Maestro Rechargeable System (P130019/S018) | Reshape Lifesciences, Inc. | 2019-01-25 |
| Lap-Band Adjustable Gastric Banding System (P000008/S046) | Medtimo, Inc. | 2019-01-18 |
| AMS Ambicor Inflatable Penile Prosthesis (IPP) (N970012/S151) | Boston Scientific Corp | 2019-01-15 |
| AspireAssist (P150024/S010) | Aspire Bariatrics, Inc. | 2019-01-15 |
| Obalon Touch Dispenser (P160001/S027) | Medtimo, Inc. | 2019-01-11 |
| Therakos CELLEX Procedural Kit (P860003/S100) | Therakos Development Limited | 2019-01-10 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary Neurostimulator Implantable InterStim) (P970004/S281) | Medtronic Neuromodulation | 2019-01-08 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Neurostimulators Implantable InterStim) (P080025/S176) | Medtronic Neuromodulation | 2019-01-08 |
| Organ Care System (OCS) Lung System (P160013/S003) | TransMedics, Inc. | 2018-12-21 |
| Obalon Balloon System with Navigation Touch (P160001/S020) | Medtimo, Inc. | 2018-12-20 |
| AMS 800 Artificial Urinary Sphincter (P000053/S096) | Boston Scientific Corp | 2018-12-20 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S095) | Boston Scientific Corp | 2018-12-19 |
| Obalon Balloon Kit (P160001/S029) | Medtimo, Inc. | 2018-12-16 |
| AMS 800 Urinary Control System (P000053/S098) | Boston Scientific Corp | 2018-12-11 |
| AMS 700 Series Product Line and the Ynaflex Inflatable Penile Prostheses (N970012/S153) | Boston Scientific Corp | 2018-12-11 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S280) | Medtronic Neuromodulation | 2018-11-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S175) | Medtronic Neuromodulation | 2018-11-30 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S044) | Medtimo, Inc. | 2018-11-30 |
| Orbera Intragastric Balloon (P140008/S014) | Boston Scientific Corporation | 2018-11-28 |
| Prolieve Thermodilation System (P030006/S028) | Medifocus, Inc. | 2018-11-21 |
| Obalon Touch Dispenser (P160001/S028) | Medtimo, Inc. | 2018-11-20 |
| AMS 700 Implantable Penile Prosthesis with and withoutInhibiZone (N970012/S152) | Boston Scientific Corp | 2018-11-16 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S279) | Medtronic Neuromodulation | 2018-11-13 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S174) | Medtronic Neuromodulation | 2018-11-13 |
| LINX Reflux Management System (P100049/S025) | Torax Medical | 2018-11-09 |
| AspireAssist (P150024/S008) | Aspire Bariatrics, Inc. | 2018-11-09 |
| Deflux Injectable Gel (P000029/S083) | Palette Life Sciences | 2018-11-08 |
| Solesta Injectable Gel (P100014/S020) | Palette Life Sciences | 2018-11-08 |
| Obalon Touch Dispenser (P160001/S025) | Medtimo, Inc. | 2018-11-07 |
| Obalon Touch Dispenser (P160001/S026) | Medtimo, Inc. | 2018-11-07 |
| Obalon Touch Dispenser (P160001/S024) | Medtimo, Inc. | 2018-11-07 |
| Therakos CELLEX Procedural Kit (P860003/S099) | Therakos Development Limited | 2018-11-01 |
| AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone) (N970012/S146) | Boston Scientific Corp | 2018-10-25 |
| Obalon Balloon System (P160001/S008) | Medtimo, Inc. | 2018-10-25 |
| AspireAssist (P150024/S012) | Aspire Bariatrics, Inc. | 2018-10-24 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S097) | Boston Scientific Corp | 2018-10-24 |
| AMS 700 Series Inflatable Penile Prosthesis (IPP) with and without InhibiZone, Ambicor IPP (N970012/S149) | Boston Scientific Corp | 2018-10-24 |
| KARL STORZ Photodynamic D-Light C (PDD) System (P050027/S013) | KARL STORZ Endoscopy-America, Inc. | 2018-10-23 |
| AMS Sphincter 800 Urinary Control System (P000053/S093) | Boston Scientific Corp | 2018-10-18 |
| LINX Reflux Management System (P100049/S024) | Torax Medical | 2018-10-16 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary Neurostimulator) (P080025/S173) | Medtronic Neuromodulation | 2018-10-09 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Neurostimulator) (P970004/S278) | Medtronic Neuromodulation | 2018-10-09 |
| Obalon Balloon System (P160001/S011) | Medtimo, Inc. | 2018-10-05 |
| Obalon Balloon System (P160001/S023) | Medtimo, Inc. | 2018-10-05 |
| Obalon Balloon System (P160001/S022) | Medtimo, Inc. | 2018-10-01 |
| Obalon Touch Inflation System (P160001/S007) | Medtimo, Inc. | 2018-09-25 |