| KARL STORZ Photodynamic D-Light C (PDD) System (P050027/S010) | KARL STORZ Endoscopy-America, Inc. | 2017-11-30 |
| COAPTITE Injectable Implant (P040047/S047) | Merz North America, Inc. | 2017-11-30 |
| KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM (P050027/S009) | KARL STORZ Endoscopy-America, Inc. | 2017-11-30 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S139) | Boston Scientific Corp | 2017-11-29 |
| PRISMAFLEX TPE 2000 Set (P830063/S010) | Vantive US Healthcare, LLC | 2017-11-21 |
| InterStim Therapy System (P080025/S149) | Medtronic Neuromodulation | 2017-11-17 |
| InterStim Therapy System (P970004/S254) | Medtronic Neuromodulation | 2017-11-17 |
| InterStim Therapy System, Verify Evalution System (SNS Bowel) (P080025/S155) | Medtronic Neuromodulation | 2017-11-16 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S260) | Medtronic Neuromodulation | 2017-11-16 |
| InterStim Therapy System, Verify Evaluation System (Bowel) (P080025/S154) | Medtronic Neuromodulation | 2017-11-09 |
| InterStim Therapy System, Verify Evaluation System (Urinary) (P970004/S259) | Medtronic Neuromodulation | 2017-11-09 |
| Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S024) | B. Braun Avitum AG | 2017-11-07 |
| InterStim Therapy System (P080025/S153) | Medtronic Neuromodulation | 2017-11-03 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S081) | Boston Scientific Corp | 2017-11-03 |
| InterStim Therapy System (P970004/S258) | Medtronic Neuromodulation | 2017-11-03 |
| InterStim Therapy System, Verify Evaluation System (P970004/S252) | Medtronic Neuromodulation | 2017-10-26 |
| ReShape Integrated Dual Balloon System (P140012/S011) | Boston Scientific Corporation | 2017-10-26 |
| InterStim Therapy System, Verify Evaluation System (Bowel) (P080025/S147) | Medtronic Neuromodulation | 2017-10-26 |
| Therakos Cellex Procedural Kit (P860003/S096) | Therakos Development Limited | 2017-10-06 |
| InterStim Therapy System, Verify Evaluation System (P970004/S257) | Medtronic Neuromodulation | 2017-10-06 |
| AMS 700 Series Product Line / Implantable Penile Prosthesis with and without InhibiZone Treatment (N970012/S138) | Boston Scientific Corp | 2017-10-06 |
| InterStim THerapy System, Verify Evaluation System (P080025/S152) | Medtronic Neuromodulation | 2017-10-06 |
| Lap-Band Adjustable Gastric Banding System (P000008/S039) | Medtimo, Inc. | 2017-10-02 |
| InterStim Therapy System (Bowl Screening) (P080025/S150) | Medtronic Neuromodulation | 2017-09-27 |
| InterStim Therapy System (Urinary Screening) (P970004/S255) | Medtronic Neuromodulation | 2017-09-27 |
| AMS 800 Artificial Urinary Sphincter (P000053/S080) | Boston Scientific Corp | 2017-09-26 |
| AMS 700 and Ambicor Inflatable Penile Prosthesis (N970012/S136) | Boston Scientific Corp | 2017-09-26 |
| InterStim Therapy System (P080025/S144) | Medtronic Neuromodulation | 2017-09-26 |
| InterStim Therapy System (Urinary) (P970004/S249) | Medtronic Neuromodulation | 2017-09-26 |
| Master InterStim Therapy System, Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S247) | Medtronic Neuromodulation | 2017-09-25 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Programming Systems) (P080025/S142) | Medtronic Neuromodulation | 2017-09-25 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S083) | Boston Scientific Corp | 2017-09-18 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S082) | Boston Scientific Corp | 2017-09-14 |
| CELLEX PHOTOPHERESIS SYSTEM (P860003/S095) | Therakos Development Limited | 2017-09-14 |
| Titan Inflatable Penile Prosthesis (P000006/S047) | Coloplast Corp. | 2017-09-08 |
| InterStim Therapy System, Verify Evaluation System (P970004/S251) | Medtronic Neuromodulation | 2017-08-24 |
| InterStim Therapy System, Verify Evaluation System (P080025/S146) | Medtronic Neuromodulation | 2017-08-24 |
| Orbera Intragastric Balloon (P140008/S007) | Boston Scientific Corporation | 2017-08-21 |
| Therakos CELLEX Procedural Kit (P860003/S094) | Therakos Development Limited | 2017-08-18 |
| THERAKOS CELLEX Photopheresis Procedural Kit (P860003/S092) | Therakos Development Limited | 2017-08-17 |
| InterStim Therapy System (SNS Bowel Programming Systems) (P080025/S143) | Medtronic Neuromodulation | 2017-08-16 |
| InterStim Therapy System (SNS Urinary Programming Systems) (P970004/S248) | Medtronic Neuromodulation | 2017-08-16 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S137) | Boston Scientific Corp | 2017-08-11 |
| InterStim Therapy System, Verify Evalution System (P080025/S145) | Medtronic Neuromodulation | 2017-08-08 |
| InterStim Therapy System, Verify Evalution System (P970004/S250) | Medtronic Neuromodulation | 2017-08-08 |
| AMBICOR INFLATABLE PENILE PROSTHESIS (N970012/S127) | Boston Scientific Corp | 2017-07-28 |
| Therakos CELLEX Photopheresis System (P860003/S090) | Therakos Development Limited | 2017-07-21 |
| OBALON BALLOON SYSTEM (P160001/S001) | Medtimo, Inc. | 2017-07-19 |
| Aspire Assist (P150024/S006) | Aspire Bariatrics, Inc. | 2017-07-17 |
| AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S126) | Boston Scientific Corp | 2017-07-13 |
| InterStim Therapy System (Bowel) (P080025/S141) | Medtronic Neuromodulation | 2017-07-07 |
| InterStim Therapy System (Urinary) (P970004/S246) | Medtronic Neuromodulation | 2017-07-07 |
| Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System (P940016/S023) | B. Braun Avitum AG | 2017-07-06 |
| ReShape Integrated Dual Ballon System (P140012/S010) | Boston Scientific Corporation | 2017-06-27 |
| COAPTITE Injectabl Implant (P040047/S045) | Merz North America, Inc. | 2017-06-27 |
| Ambicor Implantable Penile Prosthesis (N970012/S135) | Boston Scientific Corp | 2017-06-16 |
| InterStim Therapy System, Verify Evaluation System (Urinary) (P970004/S245) | Medtronic Neuromodulation | 2017-06-15 |
| Interstim Therapy System, Verify Evaluation System (SNS) Bowel (P080025/S140) | Medtronic Neuromodulation | 2017-06-15 |
| AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESIS (N970012/S114) | Boston Scientific Corp | 2017-06-15 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S062) | Boston Scientific Corp | 2017-06-15 |
| COAPTITE injectable implant (P040047/S044) | Merz North America, Inc. | 2017-06-13 |
| AMS 800 Urinary Control System (P000053/S079) | Boston Scientific Corp | 2017-06-09 |
| Orbera Intragastric Balloon System (P140008/S006) | Boston Scientific Corporation | 2017-06-06 |
| InterStim Therapy System (Urinary) (P970004/S243) | Medtronic Neuromodulation | 2017-05-25 |
| InterStim Therapy System (Urinary) (P970004/S242) | Medtronic Neuromodulation | 2017-05-25 |
| InterStim Therapy System (Bowel) (P080025/S137) | Medtronic Neuromodulation | 2017-05-25 |
| InterStim Therapy System (Bowel) (P080025/S138) | Medtronic Neuromodulation | 2017-05-25 |
| Maestro Rechargeable System (P130019/S014) | Reshape Lifesciences, Inc. | 2017-05-24 |
| InterStim Therapy System (Urinary) (P970004/S241) | Medtronic Neuromodulation | 2017-05-23 |
| InterStim Therapy System (Bowel) (P080025/S136) | Medtronic Neuromodulation | 2017-05-23 |
| LIPOSORBER(R) LA-15 SYSTEM (P910018/S022) | Kaneka Pharma America Corp. | 2017-05-23 |
| Titan Inflatable Penile Prosthesis (P000006/S046) | Coloplast Corp. | 2017-05-17 |
| InterStim Therapy System (Urinary) (P970004/S244) | Medtronic Neuromodulation | 2017-05-16 |
| Therakos Uvar XTS Photopheresis System Procedural Kit. (P860003/S089) | Therakos Development Limited | 2017-05-16 |
| InterStim Therapy System (Bowel) (P080025/S139) | Medtronic Neuromodulation | 2017-05-16 |
| AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment (N970012/S131) | Boston Scientific Corp | 2017-05-08 |
| InterStim Therapy System (P080025/S135) | Medtronic Neuromodulation | 2017-05-03 |
| InterStim Therapy System (P970004/S240) | Medtronic Neuromodulation | 2017-05-03 |
| Therakos CELLEX and UVAR XTS Procedural Kits (P860003/S088) | Therakos Development Limited | 2017-05-02 |
| ORBERA Intragastric Balloon System (P140008/S005) | Boston Scientific Corporation | 2017-05-01 |
| AMS 700 Implantable Penile Prosthesis with InhibiZone Treatment, AMS 700 Implantable Penile Prosthesis without InhibiZon (N970012/S134) | Boston Scientific Corp | 2017-04-28 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S075) | Boston Scientific Corp | 2017-04-28 |
| THERAKOS CELLEX PHOTOPHERESIS SYSTEM, INSTRUMENT, LIGHT ASSEMBLY, PROCEDURAL KIT. (P860003/S087) | Therakos Development Limited | 2017-04-27 |
| AMS 700 Implanted Penile Prosthesis (N970012/S128) | Boston Scientific Corp | 2017-04-27 |
| InterStim Therapy System (Urinary) (P970004/S239) | Medtronic Neuromodulation | 2017-04-26 |
| InterStim Therapy System (Bowel) (P080025/S134) | Medtronic Neuromodulation | 2017-04-26 |
| OBALON BALLOON SYSTEM (P160001/S003) | Medtimo, Inc. | 2017-04-25 |
| Reshape Integrated Dual Balloon System (P140012/S009) | Boston Scientific Corporation | 2017-04-20 |
| Ambicor Inflatable Penile Prosthesis. (N970012/S133) | Boston Scientific Corp | 2017-04-14 |
| DEFLUX INJECTABLE GEL (P000029/S081) | Palette Life Sciences | 2017-04-07 |
| AMS 700 Penile Prosthesis (N970012/S129) | Boston Scientific Corp | 2017-04-07 |
| SOLESTA INJECTABLE GEL (P100014/S018) | Palette Life Sciences | 2017-04-07 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S076) | Boston Scientific Corp | 2017-04-07 |
| AMS 700 Inflatable Penile Prosthesis (with and without Inhibizone Treatment) (N970012/S132) | Boston Scientific Corp | 2017-04-06 |
| AMS 800 Urinary Control System Product Line (P000053/S078) | Boston Scientific Corp | 2017-04-06 |
| SNS Urinary Neurostimulator Implantable InterStim (P970004/S238) | Medtronic Neuromodulation | 2017-04-04 |
| SNS Bowel Neurostimulators Implantable InterStim (P080025/S133) | Medtronic Neuromodulation | 2017-04-04 |
| AMS 800 Urinary Control System (P000053/S077) | Boston Scientific Corp | 2017-03-29 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S038) | Medtimo, Inc. | 2017-03-23 |
| Maestro Rechargeable System (P130019/S013) | Reshape Lifesciences, Inc. | 2017-03-22 |