| AMS 800 Urinary Control System with and without InhibiZone (P000053/S092) | Boston Scientific Corp | 2018-09-20 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S148) | Boston Scientific Corp | 2018-09-19 |
| Deflux Injectable Gel (P000029/S084) | Palette Life Sciences | 2018-09-14 |
| Solesta Injectable Gel (P100014/S021) | Palette Life Sciences | 2018-09-14 |
| LINX Reflux Management System (P100049/S023) | Torax Medical | 2018-09-06 |
| ORBERA Intragastric Balloon System (P140008/S008) | Boston Scientific Corporation | 2018-09-04 |
| Torosa Saline Filled Testicular Prosthesis (P020003/S008) | Coloplast Corp. | 2018-09-04 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S050) | Coloplast Corp. | 2018-08-31 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Extensions and Leads) (P080025/S172) | Medtronic Neuromodulation | 2018-08-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary Extensions and Leads) (P970004/S277) | Medtronic Neuromodulation | 2018-08-30 |
| ORBERA Intragastric Balloon (P140008/S013) | Boston Scientific Corporation | 2018-08-17 |
| InterStim Therapy System SNS Bowel (P080025/S171) | Medtronic Neuromodulation | 2018-08-14 |
| InterStim Therapy System SNS Urinary (P970004/S276) | Medtronic Neuromodulation | 2018-08-14 |
| Obalon Balloon Kit (P160001/S018) | Medtimo, Inc. | 2018-08-01 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S049) | Coloplast Corp. | 2018-07-27 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S091) | Boston Scientific Corp | 2018-07-23 |
| LINX Reflux Management System (P100049/S022) | Torax Medical | 2018-07-23 |
| AMS 700 Implantable Penile Prosthesis with and without InhibiZone (N970012/S147) | Boston Scientific Corp | 2018-07-23 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S043) | Medtimo, Inc. | 2018-07-20 |
| InterStim Therapy System (Bowel ) (P080025/S170) | Medtronic Neuromodulation | 2018-07-18 |
| InterStim Therapy System (Urinary) (P970004/S275) | Medtronic Neuromodulation | 2018-07-18 |
| Obalon Balloon Kit (P160001/S019) | Medtimo, Inc. | 2018-07-11 |
| InterStim Therapy System, Verify Evaluation System (P080025/S163) | Medtronic Neuromodulation | 2018-07-03 |
| Master InterStim Therapy System, Verify Evaluation System (P970004/S268) | Medtronic Neuromodulation | 2018-07-03 |
| H.E.L.P. Futura Apheresis System (P940016/S025) | B. Braun Avitum AG | 2018-06-28 |
| Obalon Balloon Kit (P160001/S015) | Medtimo, Inc. | 2018-06-22 |
| AspireAssist (P150024/S011) | Aspire Bariatrics, Inc. | 2018-06-19 |
| InterStim Therapy System, and Verify Evaluation System (SNS Urinary Neurostimulator Implantable InterStim) (P970004/S273) | Medtronic Neuromodulation | 2018-06-15 |
| InterStim Therapy System, and Verify Evaluation System (SNS Urinary Screening) (P970004/S274) | Medtronic Neuromodulation | 2018-06-15 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Neurostimulators Implantable InterStim) (P080025/S168) | Medtronic Neuromodulation | 2018-06-15 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Screening) (P080025/S169) | Medtronic Neuromodulation | 2018-06-15 |
| Organ Care System (OCS) Lung System (P160013/S001) | TransMedics, Inc. | 2018-06-14 |
| InterStim, Therapy System, Verify Evaluation System (SNS Urinary Lead) (P970004/S265) | Medtronic Neuromodulation | 2018-06-02 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Leads) (P080025/S160) | Medtronic Neuromodulation | 2018-06-02 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S167) | Medtronic Neuromodulation | 2018-06-01 |
| Obalon Balloon Kit (P160001/S017) | Medtimo, Inc. | 2018-06-01 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S272) | Medtronic Neuromodulation | 2018-06-01 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S271) | Medtronic Neuromodulation | 2018-05-31 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S166) | Medtronic Neuromodulation | 2018-05-31 |
| ReShape Integrated Dual Balloon System (P140012/S013) | Boston Scientific Corporation | 2018-05-31 |
| Obalon Balloon Kit (P160001/S016) | Medtimo, Inc. | 2018-05-31 |
| Orbera Intragastric Balloon System (P140008/S012) | Boston Scientific Corporation | 2018-05-31 |
| ReShape Integrated Dual Balloon System (P140012/S012) | Boston Scientific Corporation | 2018-05-30 |
| InterStim Therapy System, Verify Evaluation System (Bowel) (P080025/S165) | Medtronic Neuromodulation | 2018-05-24 |
| InterStim Therapy System, Verify Evaluation System (Urinary) (P970004/S270) | Medtronic Neuromodulation | 2018-05-24 |
| Karl Storz Photodynamic D-Light C (PDD) System (P050027/S012) | KARL STORZ Endoscopy-America, Inc. | 2018-05-22 |
| COAPTITE Injectable Implant (P040047/S051) | Merz North America, Inc. | 2018-05-15 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S090) | Boston Scientific Corp | 2018-05-14 |
| AMS 800 Urinary Control System with and without Inhibizone (P000053/S089) | Boston Scientific Corp | 2018-05-11 |
| InterStim Therapy System, Verify Evaluation System (P970004/S269) | Medtronic Neuromodulation | 2018-05-11 |
| InterStim Therapy System, Verify Evaluation System (P080025/S164) | Medtronic Neuromodulation | 2018-05-11 |
| Obalon Balloon System (P160001/S014) | Medtimo, Inc. | 2018-04-28 |
| InterStim Therapy System, Verify Evaluation System (P970004/S256) | Medtronic Neuromodulation | 2018-04-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S162) | Medtronic Neuromodulation | 2018-04-13 |
| InterStim Therapy System, Verify Evaluation System (P970004/S267) | Medtronic Neuromodulation | 2018-04-13 |
| InterStim Therapy System. Verify Evaluation System (P080025/S151) | Medtronic Neuromodulation | 2018-04-13 |
| Liposorber LA-15 System (P910018/S025) | Kaneka Pharma America Corp. | 2018-04-12 |
| InterStim Therapy System, Verify Evaluation System (P080025/S161) | Medtronic Neuromodulation | 2018-04-09 |
| InterStim Therapy System, Verify Evaluation System (P970004/S266) | Medtronic Neuromodulation | 2018-04-09 |
| Ambicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP (N970012/S145) | Boston Scientific Corp | 2018-04-06 |
| Coaptite Injectable Implant (P040047/S046) | Merz North America, Inc. | 2018-03-28 |
| LIPOSORBER LA-15 System (P910018/S024) | Kaneka Pharma America Corp. | 2018-03-26 |
| Obalon Balloon System (P160001/S013) | Medtimo, Inc. | 2018-03-23 |
| Organ Care System (OCS) Lung System (P160013) | TransMedics, Inc. | 2018-03-22 |
| Linx Reflux Management System (P100049/S021) | Torax Medical | 2018-03-15 |
| Therakos Cellex Procedural Kit (P860003/S098) | Therakos Development Limited | 2018-03-08 |
| AspireAssist (P150024/S009) | Aspire Bariatrics, Inc. | 2018-02-23 |
| Karl Storz D-Light C PDD System (P050027/S011) | KARL STORZ Endoscopy-America, Inc. | 2018-02-15 |
| Plasmaflo OP-05W(A) (P820033/S012) | Asahi Kasei Medical Co., Ltd. | 2018-02-15 |
| Urinary Control System (P000053/S087) | Boston Scientific Corp | 2018-02-13 |
| Inflatable Penile Prosthesis (N970012/S144) | Boston Scientific Corp | 2018-02-13 |
| Coaptite (P040047/S049) | Merz North America, Inc. | 2018-02-12 |
| InterStim® Sacral Nerve Stimulation Therapy System / Bowel Control (P080025/S148) | Medtronic Neuromodulation | 2018-02-07 |
| InterStim® Sacral Nerve Stimulation Therapy System (Urinary Control ) (P970004/S253) | Medtronic Neuromodulation | 2018-02-07 |
| InterStim Therapy System, Verify Evaluation System; SNM Bowel Leads (P080025/S156) | Medtronic Neuromodulation | 2018-02-06 |
| InterStim Therapy System, Verify Evaluation System; SNM Urinary Leads (P970004/S261) | Medtronic Neuromodulation | 2018-02-06 |
| AMS 800 Urinary Control System with and without InhibiZone Treatment (P000053/S086) | Boston Scientific Corp | 2018-02-01 |
| AMS 800 Urinary Control System with and without Inhibizone (P000053/S088) | Boston Scientific Corp | 2018-02-01 |
| AMS 700 Implantable/Inflatable Penile Prosthesis with and without InhibiZone Treatment (N970012/S143) | Boston Scientific Corp | 2018-01-30 |
| Linx Reflux Management System (P100049/S020) | Torax Medical | 2018-01-29 |
| Therakos Cellex Photopheresis System (P860003/S093) | Therakos Development Limited | 2018-01-28 |
| Therakos Cellex Photopheresis System (P860003/S097) | Therakos Development Limited | 2018-01-26 |
| Obalon Balloon System (P160001/S009) | Medtimo, Inc. | 2018-01-26 |
| Maestro Rechargeable System (P130019/S015) | Reshape Lifesciences, Inc. | 2018-01-24 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S042) | Medtimo, Inc. | 2018-01-23 |
| Maestro Rechargeable System (P130019/S016) | Reshape Lifesciences, Inc. | 2018-01-22 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S041) | Medtimo, Inc. | 2018-01-18 |
| Plasmaflo (P820033/S011) | Asahi Kasei Medical Co., Ltd. | 2018-01-17 |
| Obalon Balloon System (P160001/S010) | Medtimo, Inc. | 2018-01-16 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S040) | Medtimo, Inc. | 2018-01-16 |
| Orbera Intragastric Balloon System (P140008/S011) | Boston Scientific Corporation | 2018-01-12 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S140) | Boston Scientific Corp | 2017-12-18 |
| AMS 700 Implantable Penile Prosthesis (with and without InhibiZone Treatment) / AMS Ambicor Implantable Penile Prosthesi (N970012/S141) | Boston Scientific Corp | 2017-12-15 |
| AMS 800 Urinary Control System (with and without Inhibizone Treatment) (P000053/S084) | Boston Scientific Corp | 2017-12-15 |
| InterStim Therapy System, Verify Evaluation System (P970004/S264) | Medtronic Neuromodulation | 2017-12-14 |
| InterStim Therapy System, Verify Evaluation System (P080025/S159) | Medtronic Neuromodulation | 2017-12-14 |
| InterStim Therapy System, Verify Evaluation System (P970004/S262) | Medtronic Neuromodulation | 2017-12-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S157) | Medtronic Neuromodulation | 2017-12-13 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S085) | Boston Scientific Corp | 2017-12-12 |
| AMS 700 Implantable Penile Prosthesis with and without InhibiZone (N970012/S142) | Boston Scientific Corp | 2017-12-12 |