| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses, Biofinity Sphere/Biofinity XR Sphere, Biofinity Energys, Bi (P080011/S075) | CooperVision, Inc. | 2018-06-01 |
| SAPIEN XT Transcatheter Heart Valve (P130009/S090) | Edwards Lifesciences, LLC | 2018-05-31 |
| 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 |
| CapSureFix MRI Lead (P090013/S284) | Medtronic, Inc. | 2018-05-31 |
| SynchroMed Infusion Sysstem, Ascenda Intrathecal Catheters (P860004/S306) | Medtronic, Inc. | 2018-05-31 |
| SLS II/Glide Light Catheters (P960042/S061) | Spectranetics (Philips) | 2018-05-31 |
| CapSure Sense Lead (P830061/S158) | Medtronic Cardiac Rhythm Disease Management | 2018-05-31 |
| GORE Cardioform Septal Occluder (P050006/S068) | W. L. Gore & Associates, Inc. | 2018-05-31 |
| Implantable System for Remodulin (P140032/S007) | Medtronic, Inc. | 2018-05-31 |
| ReShape Integrated Dual Balloon System (P140012/S013) | Boston Scientific Corporation | 2018-05-31 |
| SAPIEN 3 Transcatheter Heart Valve (P140031/S066) | Edwards Lifesciences, LLC | 2018-05-31 |
| Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S022) | Edwards Lifesciences, LLC | 2018-05-31 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic BIoprosthesis with ThermaFix tis (P860057/S179) | Edwards Lifesciences, LLC | 2018-05-31 |
| Activa Deep Brain Stimulation Therapy System (P960009/S314) | Medtronic, Inc. | 2018-05-31 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR/SR MRI IPG, Sphera DR/SR MRI IPG (P980035/S554) | Medtronic, Inc. | 2018-05-31 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S397) | Medtronic Neuromodulation | 2018-05-31 |
| Obalon Balloon Kit (P160001/S016) | Medtimo, Inc. | 2018-05-31 |
| HeartMate 3 Left Ventricular Assist System (P160054/S006) | ABBOTT MEDICAL | 2018-05-31 |
| Orbera Intragastric Balloon System (P140008/S012) | Boston Scientific Corporation | 2018-05-31 |
| CapSureFix Novus Lead (P930039/S187) | Medtronic, Inc. | 2018-05-31 |
| EDWARDS INTUITY ELITE Valve System (P150036/S030) | Edwards Lifesciences, LLC | 2018-05-31 |
| Mobi-C Cervical Disc Prosthesis (P110009/S020) | Highridge Medical, LLC | 2018-05-30 |
| Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013) | MicroVention, Inc. | 2018-05-30 |
| XIENCE Xpedition Everolimus Eluting Coronary Stent System, SV (2.25), LL; XIENCE Alpine Everolimus Eluting Coronary Sten (P110019/S098) | Abbott Vascular | 2018-05-30 |
| Mobi-C Cervical Disc Prosthesis (P110002/S020) | Highridge Medical, LLC | 2018-05-30 |
| Consulta CRT-P, Syncra CRT-P and Viva CRT-P (P010015/S369) | Medtronic, Inc. | 2018-05-30 |
| MiniMed 530G Insulin Pump (P120010/S116) | Medtronic, Inc. | 2018-05-30 |
| Viva, Brava, Protecta, Protecta XT, Concerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl (P010031/S628) | Medtronic Cardiac Rhythm Disease Management | 2018-05-30 |
| MyCareLink Monitor 4G Cellular Modem (P890003/S390) | Medtronic, Inc. | 2018-05-30 |
| ReShape Integrated Dual Balloon System (P140012/S012) | Boston Scientific Corporation | 2018-05-30 |
| Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System (P150023/S010) | Abbott Vascular, Inc. | 2018-05-30 |
| Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse and Kappa (P980035/S550) | Medtronic, Inc. | 2018-05-30 |
| Micra (P150033/S036) | Medtronic, Inc. | 2018-05-30 |
| Revo MRI (P090013/S282) | Medtronic, Inc. | 2018-05-30 |
| Paradigm Real-Time Revel Insulin Pump (P150019/S042) | Medtronic Minimed | 2018-05-30 |
| Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II and Visia AF (P980016/S670) | Medtronic Cardiac Rhythm Disease Management | 2018-05-30 |
| CyPass Micro-Stent (P150037/S009) | Alcon Research, Ltd. | 2018-05-30 |
| Paradigm Real-Time Insulin Pump, Paradigm Real-Time Revel Insulin Pump (P980022/S204) | Medtronic Minimed | 2018-05-30 |
| CustomFlex Artificial Iris (P170039) | Humanoptics AG | 2018-05-30 |
| Everolimus Eluting Coronary Stent System (P070015/S141) | Abbott Vascular, Inc. | 2018-05-30 |
| Attune Revision Tibial Augments (P830055/S200) | Depuy, Inc. | 2018-05-29 |
| iStent Trabecular Micro-Bypass Stent System (P080030/S021) | Glaukos Corporation | 2018-05-29 |
| Tendril MRI (P140033/S030) | ABBOTT MEDICAL | 2018-05-29 |
| CyPass System 241-S (P150037/S007) | Alcon Research, Ltd. | 2018-05-29 |
| OneStep Pacing Cable Assembly used wit R Series Device (P160022/S002) | ZOLL Medical Corporation | 2018-05-29 |
| Activa Deep Brain Stimulation Therapy System (P960009/S304) | Medtronic, Inc. | 2018-05-26 |
| Impella 2.5 and Impella CP Ventricular Support Systems (P140003/S035) | Abiomed, Inc. | 2018-05-25 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) Balloon Catheter (P140010/S039) | Medtronic, Inc. | 2018-05-25 |
| Supartz FX, Visco-3 (P980044/S045) | Seikagaku Corp. | 2018-05-25 |
| Oncomine Dx Target Test (P160045/S006) | Life Technologies Corporation | 2018-05-25 |
| Gore Tigris Vascular Stent (P160004/S009) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Carbomedics Prosthetic Heart Valve (P900060/S057) | Corcym S.r.l. | 2018-05-24 |
| Gore Tag Thoracic Endoprosthesis (P040043/S099) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| SynchroMed Infusion System (P860004/S304) | Medtronic, Inc. | 2018-05-24 |
| HeartWare Ventricular Assist System (P100047/S121) | Medtronic | 2018-05-24 |
| Activa Deep Brain Stimulation Therapy System (P960009/S313) | Medtronic, Inc. | 2018-05-24 |
| Impella 2.5, Impella CP Ventricular Support Systems (P140003/S034) | Abiomed, Inc. | 2018-05-24 |
| VISTAKON (etafilcon A) ACUVUE 2 Brand Contact Lenses (N18033/S098) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2018-05-24 |
| Gore Viatorr Tips Endoprosthesis; Gore Viatorr Tips Endoprosthesis with Controlled Expansion (P040027/S061) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S006) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Misago RX Self-Expanding Peripheral Stent (P140002/S016) | Terumo Medical Corporation | 2018-05-24 |
| InterStim Therapy System, Verify Evaluation System (Bowel) (P080025/S165) | Medtronic Neuromodulation | 2018-05-24 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S305) | Medtronic, Inc. | 2018-05-24 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S051) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| InterStim Therapy System, Verify Evaluation System (Urinary) (P970004/S270) | Medtronic Neuromodulation | 2018-05-24 |
| Gore Helex Septal Occluder, Gore CardioForm Septal Occluder (P050006/S065) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Master Restore, Itrel, Synergy snd Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S396) | Medtronic Neuromodulation | 2018-05-24 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S112) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprsthesis (P020004/S152) | W. L. Gore & Associates, Inc. | 2018-05-24 |
| Nucleus 24 Cochlear Implant System (Nucleus 7 Sound Processor) (P970051/S179) | Cochlear Americas | 2018-05-24 |
| Sculptra and Sculptra Aesthetic (P030050/S029) | Q-Med AB | 2018-05-23 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2), Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control ( (P100039/S005) | Siemens Healthcare Diagnostics, Inc. | 2018-05-23 |
| Medtronic MiniMed 530G System (P120010/S115) | Medtronic, Inc. | 2018-05-23 |
| Advia Centaur HBsll (P110041/S005) | Siemens Corp. | 2018-05-23 |
| Guardian Connect System (P160007/S001) | Medtronic Minimed | 2018-05-23 |
| Medtronic MiniMed iPro2 CGM System with Elite Sensor (P150029/S018) | Medtronic Minimed | 2018-05-23 |
| MitraClip System (NTR and XTR) (P100009/S025) | ABBOTT MEDICAL | 2018-05-23 |
| Medtronic MiniMed 630G System (P150001/S042) | Medtronic Minimed | 2018-05-23 |
| Medtronic MiniMed 670G System (P160017/S040) | Medtronic Minimed, Inc. | 2018-05-23 |
| NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S056) | Zimmer, Inc. | 2018-05-23 |
| Medtronic MiniMed Paradigm Real-Time Revel System (P150019/S041) | Medtronic Minimed | 2018-05-23 |
| XIENCE Sierra Everolimus Eluting Coronary Stent System (P110019/S094) | Abbott Vascular | 2018-05-22 |
| EXOGEN Ultrasound Bone Healing System (P900009/S043) | Bioventus, LLC | 2018-05-22 |
| Lotrafilcon A Soft Contact Lenses for Extended Wear (P010019/S065) | Alcon Laboratories, Inc. | 2018-05-22 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S051) | Boston Scientific Corp | 2018-05-22 |
| LCS(R) Total Knee System (P830055/S201) | Depuy, Inc. | 2018-05-22 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S156) | Boston Scientific Corp | 2018-05-22 |
| Karl Storz Photodynamic D-Light C (PDD) System (P050027/S012) | KARL STORZ Endoscopy-America, Inc. | 2018-05-22 |
| Rebel Platinum Chromium Coronary Stent System (Monorail) (P130030/S049) | Boston Scientific Corp | 2018-05-21 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S001) | Berlin Heart, Inc. | 2018-05-21 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S672) | Medtronic Cardiac Rhythm Disease Management | 2018-05-21 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar Bipolar CRT-P, (P010015/S357) | Medtronic, Inc. | 2018-05-21 |
| Algovita Spinal Cord Stimulation System (P130028/S020) | Nuvectra Corporation | 2018-05-21 |
| 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/S630) | Medtronic Cardiac Rhythm Disease Management | 2018-05-21 |
| DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit (P150004/S022) | ABBOTT MEDICAL | 2018-05-19 |
| Gore Viatorr Tips Endoprosthesis (P040027/S060) | W. L. Gore & Associates, Inc. | 2018-05-18 |
| SynchroMed Infusion System / Ascenda Intrathecal Catheters (P860004/S294) | Medtronic, Inc. | 2018-05-18 |
| MFC-CPRD Cable Assembly used with X Series and R Series Device (P160022/S003) | ZOLL Medical Corporation | 2018-05-18 |
| Adapta, Versa, Sensia IPG, Attesta IPG, Relia IPG, Sphera IPG (P980035/S552) | Medtronic, Inc. | 2018-05-18 |