| Rebel Platinum Chromium Coronary Stent System (P130030/S047) | Boston Scientific Corp | 2017-12-15 |
| HEMOBLAST™ Bellows (P170012) | Dilon Technologies, Inc. | 2017-12-15 |
| Amplia MRI CRT-D, Brava CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Viva S CRT-D, Viva XT CRT-D (P010031/S613) | Medtronic Cardiac Rhythm Disease Management | 2017-12-15 |
| HeartWare HVAD System (P100047/S101) | Medtronic | 2017-12-15 |
| Dimension Vista FPSA Flex reagent cartridge (K6452) (P020027/S030) | Siemens Healthcare Diagnostics | 2017-12-15 |
| 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 |
| SlimTip DRG Trial Lead Kit, 50cm & 90cm / SlimTip DRG Implant Lead Kit, 50cm & 90cm / DRG Lead Extension Kit. (P150004/S017) | ABBOTT MEDICAL | 2017-12-15 |
| Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI VR ICD, Visia AF VR ICD (P980016/S652) | Medtronic Cardiac Rhythm Disease Management | 2017-12-15 |
| Multi-Link 8 Coronary Stent System (P020047/S065) | Abbott Vascular | 2017-12-15 |
| Avalus Bioprosthesis, Model 400 (P170006/S005) | Medtronic, Inc. | 2017-12-15 |
| Express SD Renal Monorail Premounted Stent System (P060006/S089) | Boston Scientific Corp | 2017-12-15 |
| Cordis Precise Nitinol Stent System (P030047/S034) | Cordis US Corporation | 2017-12-15 |
| On-X Ascending Aortic Prosthesis (P000037/S051) | On-X Life Technologies, Inc. | 2017-12-14 |
| InterStim Therapy System, Verify Evaluation System (P970004/S264) | Medtronic Neuromodulation | 2017-12-14 |
| HV splitter/adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Subcutaneous Lead, Transve (P920015/S203) | Medtronic, Inc. | 2017-12-14 |
| Attain Ability Lead, Attain Performa Lead (P080006/S116) | Medtronic, Inc. | 2017-12-14 |
| Cordis Exoseal Vascular Closure Device (P100013/S015) | Cordis US Corporation | 2017-12-14 |
| Epicardial Patch Lead (P900061/S147) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Gel-One (P080020/S027) | Seikagaku Corp. | 2017-12-14 |
| Juvederm Volbella XC (P110033/S035) | Allergan | 2017-12-14 |
| CapSure Epicardial Pacing Lead (P950024/S077) | Medtronic, Inc. | 2017-12-14 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prote (P980016/S650) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Micra TPS (P150033/S028) | Medtronic, Inc. | 2017-12-14 |
| Myocardial Pacing Lead (P120017/S011) | Medtronic, Inc. | 2017-12-14 |
| SelectSecure Lead (P030036/S097) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| InterStim Therapy System, Verify Evaluation System (P080025/S159) | Medtronic Neuromodulation | 2017-12-14 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S090) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-12-14 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S129) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| SCULPTRA & SCULPTRA Aesthetic (P030050/S027) | Q-Med AB | 2017-12-14 |
| QVCAD System (Version 3.3) (P150043/S001) | Qview Medical, Inc. | 2017-12-14 |
| Spinal Cord Stimulation Leads; Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems adn Pisces, S (P840001/S385) | Medtronic Neuromodulation | 2017-12-14 |
| Epic Vascular Self-Expanding Stent System (P110035/S044) | Boston Scientific Corp | 2017-12-14 |
| Activa Deep Brain Stimulation Therapy System (P960009/S305) | Medtronic, Inc. | 2017-12-14 |
| Innova Self-Expanding Stent System (P140028/S030) | Boston Scientific Corporation | 2017-12-14 |
| Transvene CS/SVC Lead (P980050/S113) | Medtronic, Inc. | 2017-12-14 |
| Ceramax Ceramic Total Hip System (P070026/S050) | DePuy Orthopaedics, Inc. | 2017-12-14 |
| SUPARTZ FX / VISCO-3 (P980044/S041) | Seikagaku Corp. | 2017-12-14 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S348) | Medtronic, Inc. | 2017-12-14 |
| Attain StarFix Lead (P060039/S082) | Medtronic, Inc. | 2017-12-14 |
| Nucleus 24 Cochlear Implant System (P970051/S157) | Cochlear Americas | 2017-12-14 |
| Melody TPV System (P140017/S010) | Medtronic, Inc. | 2017-12-14 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S069) | Medtronic Cryocath, LP | 2017-12-14 |
| CapSureFix MRI Lead, Revo MRI SureScan IPG (P090013/S267) | Medtronic, Inc. | 2017-12-14 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S292) | Medtronic, Inc. | 2017-12-14 |
| Nucleus 22 Cochlear Implant System (P840024/S089) | Cochlear Americas | 2017-12-14 |
| Nucleus 22 Cochlear Implant System (P890027/S058) | Cochlear Americas | 2017-12-14 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S152) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, (P980035/S528) | Medtronic, Inc. | 2017-12-14 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S035) | Boston Scientific Corporation | 2017-12-14 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active, Fixation Lead (P930039/S178) | Medtronic, Inc. | 2017-12-14 |
| CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S383) | Medtronic, Inc. | 2017-12-14 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S611) | Medtronic Cardiac Rhythm Disease Management | 2017-12-14 |
| Gore Tigris Vascular Stent (P160004/S007) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Impella RP System (P170011/S001) | Abiomed, Inc. | 2017-12-13 |
| InterStim Therapy System, Verify Evaluation System (P970004/S262) | Medtronic Neuromodulation | 2017-12-13 |
| INFUSE Bone Graft / LT-Cage Lumbar Tapered Fusion Device (P000058/S068) | Medtronic Sofamor Danek USA, Inc. | 2017-12-13 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant (P010012/S465) | Boston Scientific Corp | 2017-12-13 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S383) | Medtronic Neuromodulation | 2017-12-13 |
| Infuse Bone Graft (P000054/S049) | Medtronic Sofamor Danek USA, Inc. | 2017-12-13 |
| Latitude NXT Patient Management System, Wave Communicator, G2 Communicator, Consult Communicator, NXT System Server Soft (P910077/S162) | Boston Scientific | 2017-12-13 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S099) | Abbott Vascular, Inc. | 2017-12-13 |
| Revo MRI SureScan IPG (P090013/S268) | Medtronic, Inc. | 2017-12-13 |
| Hancock II Bioprosthesis & Hancock Ultra II Bisprosthesis (P980043/S062) | Medtronic, Inc. | 2017-12-13 |
| Infuse Bone Graft (P050053/S040) | Boston Scientific Corp | 2017-12-13 |
| Open Pivot Heart Valve / Aortic Valved Graft (P990046/S050) | Medtronic Ats Medical, Inc. | 2017-12-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S302) | Medtronic, Inc. | 2017-12-13 |
| Oxford Partial Knee System - Femoral and Tibial Tray Components (P010014/S068) | Biomet Manufacturing Corp | 2017-12-13 |
| Emblem (P110042/S092) | Boston Scientific Corporation | 2017-12-13 |
| Hancock Valved Conduiis (P870078/S037) | Medtronic, Inc. | 2017-12-13 |
| Evera MRI ICD,Evera S DR ICD,Evera MRI DF-1 ICD,Evera S VR ICD,Evera XT DR ICD, Evera XT VR ICD,Protecta ICD, Protecta V (P980016/S651) | Medtronic Cardiac Rhythm Disease Management | 2017-12-13 |
| Mosaic Bioprosthesis & Ultra Bioprosthesis (P990064/S070) | Medtronic, Inc. | 2017-12-13 |
| Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Pervica (P960040/S406) | Boston Scientific | 2017-12-13 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S043) | Boston Scientific | 2017-12-13 |
| Gore Viabahn Endoprosthesis (P040037/S107) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Adapta,Versa,Sensia IPG, Adapta,Versa,Sensia IPG,Advisa DR IPG, Advisa DR MRI IPG,Advisa SR MRI IPG,Relia IPG (P980035/S529) | Medtronic, Inc. | 2017-12-13 |
| Gore Excluder AAA Endoprosthesis (P020004/S149) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Freestyle Bioprosthesis (P970031/S058) | Medtronic, Inc. | 2017-12-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S157) | Medtronic Neuromodulation | 2017-12-13 |
| Invive, Intua, Visionist, Valitude (P030005/S161) | Guidant Corp. | 2017-12-13 |
| Hancock Modified Orifice Valved Conduit (P790007/S052) | Medtronic Heart Valves | 2017-12-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D,Claria MRI Quad CRT-D, Compia M (P010031/S612) | Medtronic Cardiac Rhythm Disease Management | 2017-12-13 |
| Advantio, Ingenio, Vitalio, formio, Essentio, Accolade, Proponent, Insignia, Altrua 2 (N970003/S213) | Boston Scientific Corp | 2017-12-13 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S349) | Medtronic, Inc. | 2017-12-13 |
| Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S046) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| Gore Tag Thoracic Endoprosthesis (P040043/S097) | W. L. Gore & Associates, Inc. | 2017-12-13 |
| PSW 1704.U (P070008/S087) | Biotronik, Inc. | 2017-12-12 |
| Activa Deep Brain Stimulation Therapy System (P960009/S306) | Medtronic, Inc. | 2017-12-12 |
| Core Valve Evolut R System and Core Valve Evolut PRO System (P130021/S048) | Medtronic, Inc. | 2017-12-12 |
| PSW 1704.U (P950037/S182) | Biotronik, Inc. | 2017-12-12 |
| WCD 4000 LifeVest Wearable Defibrillator (P010030/S103) | Zoll Manufacturing Corporation | 2017-12-12 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S085) | Boston Scientific Corp | 2017-12-12 |
| Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Visia AF MRI DF1 IC (P980016/S648) | Medtronic Cardiac Rhythm Disease Management | 2017-12-12 |
| Tendril MRI Leads (P140033/S014) | ABBOTT MEDICAL | 2017-12-12 |
| PSW 1704.U (P050023/S113) | Biotronik, Inc. | 2017-12-12 |
| Master Restore, Itrel, and Intellis Spinal Cord Stimulation Systems (P840001/S386) | Medtronic Neuromodulation | 2017-12-12 |
| Comflicon A Soft (Hydrophilic ) Extended Wear Contact Lenses (P080011/S064) | CooperVision, Inc. | 2017-12-12 |
| Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Compia (P010031/S609) | Medtronic Cardiac Rhythm Disease Management | 2017-12-12 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S150) | Boston Scientific Corp | 2017-12-12 |
| TECNIS Symfony 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, and TECNIS Multifocal 1-Piece IOL (P980040/S085) | Johnson & Johnson Surgical Vision, Inc. | 2017-12-12 |