| Implantable System for Remodulin (P140032/S002) | Medtronic, Inc. | 2018-04-17 |
| Nirxcell CoCr Coronary Stent on RX System (P110004/S028) | Medinol, Ltd. | 2018-04-17 |
| Life Vest Wearable Defibrillator (P010030/S102) | Zoll Manufacturing Corporation | 2018-04-17 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S015) | Abbott Diabetes Care, Inc. | 2018-04-17 |
| Gore Cardioform Septal Occluder (P050006/S064) | W. L. Gore & Associates, Inc. | 2018-04-17 |
| Immulite/Immulite 1000 PSA/Immulite 2000 PSA (P930027/S019) | Siemens Healthcare Diagnostics, Inc. | 2018-04-16 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S089) | Medtronic Vascular | 2018-04-16 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S001) | Celonova Biosciences, Inc. | 2018-04-16 |
| Adapta, Versa, Sensia IPG, Attesta IPG, Relia IPG, Sphera IPG (P980035/S542) | Medtronic, Inc. | 2018-04-16 |
| Impella CP System (P140003/S031) | Abiomed, Inc. | 2018-04-16 |
| Xience Prime, Xience Prime SV, Xience Prime LL, Xience Xpedition, Xience Xpedition SV, Xience Xpedition LL, Xience Alpin (P110019/S100) | Abbott Vascular | 2018-04-16 |
| HeartLight Endoscopic Ablation System (P150026/S004) | Cardiofocus, Inc. | 2018-04-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S015) | Medtronic Vascular | 2018-04-16 |
| StarClose SE Vascular Closure System (P050007/S035) | Abbott Vascular Devices | 2018-04-16 |
| Resolute Onyx Zotarolimus-eluting Coronary Stent Systems (P160043/S014) | Medtronic Vascular | 2018-04-16 |
| Xience V Everolimus Eluting Coronary Stent System, Xience nano Everolimus Eluting Coronary Stent System (P070015/S142) | Abbott Vascular, Inc. | 2018-04-16 |
| Gore Tigris Vascular Stent (P160004/S008) | W. L. Gore & Associates, Inc. | 2018-04-13 |
| Dimension TPSA Flex Reagent Cartridge (P000021/S033) | Siemens Healthcare Diagnostics | 2018-04-13 |
| Dimension FPSA Flex Reagent Cartridge (P020027/S028) | Siemens Healthcare Diagnostics | 2018-04-13 |
| InterStim Therapy System, Verify Evaluation System (P970004/S256) | Medtronic Neuromodulation | 2018-04-13 |
| SynchroMed Infusion System Ascenda Intrathecal Catheters (P860004/S290) | Medtronic, Inc. | 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 |
| Oxford Partial Knee System (P010014/S072) | Biomet Manufacturing Corp | 2018-04-13 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S015) | Gen-Probe Incorporated | 2018-04-13 |
| ADVIA CENTAUR AFP ASSAY (P930036/S006) | Siemens Healthcare Diagnostics, Inc. | 2018-04-13 |
| Gel-Flow NT (N18286/S030) | Pfizer, Inc. | 2018-04-13 |
| HeartWare Ventricular Assist System (P100047/S118) | Medtronic | 2018-04-13 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S (P840001/S377) | Medtronic Neuromodulation | 2018-04-13 |
| Aptima HPV Assay (P100042/S017) | Gen-Probe Incorporated | 2018-04-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S294) | Medtronic, Inc. | 2018-04-13 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S392) | Medtronic Neuromodulation | 2018-04-13 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S393) | Medtronic Neuromodulation | 2018-04-13 |
| InterStim Therapy System. Verify Evaluation System (P080025/S151) | Medtronic Neuromodulation | 2018-04-13 |
| Bella Skin Test Tray (P020012/S024) | Tiger Aesthetics Medical, LLC | 2018-04-13 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S361) | Medtronic, Inc. | 2018-04-12 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S182) | Medtronic, Inc. | 2018-04-12 |
| Edwards Intuity Elite Valve System (P150036/S028) | Edwards Lifesciences, LLC | 2018-04-12 |
| Edwards Pericardial Aortic Bioprothesis, Inspiris Resilia Aortic Valve (P150048/S019) | Edwards Lifesciences, LLC | 2018-04-12 |
| Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S543) | Medtronic, Inc. | 2018-04-12 |
| CapSureFix MRI Lead (P090013/S273) | Medtronic, Inc. | 2018-04-12 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Perimount Theon Pericardial Aortic Bioprothesis with Ther (P860057/S177) | Edwards Lifesciences, LLC | 2018-04-12 |
| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S062) | Edwards Lifesciences, LLC | 2018-04-12 |
| OraQuick HCV Rapid Antibody Test (P080027/S033) | OraSure Technologies, Inc. | 2018-04-12 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S087) | Edwards Lifesciences, LLC | 2018-04-12 |
| Liposorber LA-15 System (P910018/S025) | Kaneka Pharma America Corp. | 2018-04-12 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S078) | Alcon Research, Ltd. | 2018-04-11 |
| Accolade, Altrua 2, Essentio, Proponent (N970003/S227) | Boston Scientific Corp | 2018-04-11 |
| Bellafill Dermal Filler (P020012/S023) | Tiger Aesthetics Medical, LLC | 2018-04-11 |
| Praxis Extended RAS Panel (P160038/S001) | Illumina, Inc. | 2018-04-11 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+family of ICDS (P910023/S400) | ABBOTT MEDICAL | 2018-04-11 |
| Accolade MRI, Essentio MRI, Proponent MRI (P150012/S055) | Boston Scientific | 2018-04-11 |
| PartoSure test (P160052) | Qiagen, Inc. | 2018-04-11 |
| Oxford Partial Knee System (P010014/S074) | Biomet Manufacturing Corp | 2018-04-11 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S344) | ABBOTT MEDICAL | 2018-04-11 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S293) | ABBOTT MEDICAL | 2018-04-11 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S164) | ABBOTT MEDICAL | 2018-04-11 |
| AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S111) | Alcon Laboratories, Inc. | 2018-04-11 |
| Assurity MRI Endurity MRI family of Pacemakers (P140033/S022) | ABBOTT MEDICAL | 2018-04-11 |
| Microny family of Pacemakers (P970013/S076) | ABBOTT MEDICAL | 2018-04-11 |
| 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/S621) | Medtronic Cardiac Rhythm Disease Management | 2018-04-10 |
| MiniMed 630G System with SmartGuard (P150001/S041) | Medtronic Minimed | 2018-04-10 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR/SR MRI IPG; Astra XT DR MRI IPG; Astra S DR/SR MRI IPG; Astra XT SR (P980035/S540) | Medtronic, Inc. | 2018-04-10 |
| Revo MRI SureScan IPG (P090013/S272) | Medtronic, Inc. | 2018-04-10 |
| NG2.5 (Dynagen Mini/Inogen Mini/ Origen Mini), Pervica ICD Pulse Generator (P960040/S424) | Boston Scientific | 2018-04-10 |
| EGFR pharmDx (P030044/S005) | Agilent Technologies, Inc. | 2018-04-10 |
| Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism (P080011/S066) | CooperVision, Inc. | 2018-04-10 |
| Paradigm Real-Time Revel System (P150019/S040) | Medtronic Minimed | 2018-04-10 |
| Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S073) | CooperVision, Inc. | 2018-04-10 |
| MiniMed 530G System (P120010/S114) | Medtronic, Inc. | 2018-04-10 |
| iPro2 System (P150029/S017) | Medtronic Minimed | 2018-04-10 |
| MiniMed 670G System (P160017/S039) | Medtronic Minimed, Inc. | 2018-04-10 |
| Bausch & Lomb PureVision (balafilcon A) Contact Lenses (P980006/S027) | Bausch & Lomb, Inc. | 2018-04-10 |
| Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR/VR ICD; Evera XT DR/VR ICD; Mirro MRI DR/VR ICD; Primo MRI DR/VR ICD; Visi (P980016/S661) | Medtronic Cardiac Rhythm Disease Management | 2018-04-10 |
| PD-L1 IHC 22C3 PharmDx (P150013/S010) | Agilent Technologies, Inc. | 2018-04-10 |
| PD-L1 IHC 28-8 pharmDx (P150025/S009) | Agilent Technologies, Inc. | 2018-04-10 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S360) | Medtronic, Inc. | 2018-04-10 |
| Aptima HCV Quant Dx Assay (P160023/S002) | Hologic, Inc. | 2018-04-10 |
| Aptima HBV Quant Assay (P170025/S002) | Hologic, Inc. | 2018-04-10 |
| Hemoblast Bellows (P170012/S002) | Dilon Technologies, Inc. | 2018-04-10 |
| Micra TPS (P150033/S033) | Medtronic, Inc. | 2018-04-10 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S299) | Medtronic, Inc. | 2018-04-09 |
| SynchroMed II Infusion Pump (P140032/S003) | Medtronic, Inc. | 2018-04-09 |
| AquaClear Premium (P080011/S067) | CooperVision, Inc. | 2018-04-09 |
| Gelfoam Sterile Sponge (N18286/S031) | Pfizer, Inc. | 2018-04-09 |
| Wave Light EX500 Laser (P020050/S028) | Alcon Laboratories, Inc. | 2018-04-09 |
| Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG (P980035/S539) | Medtronic, Inc. | 2018-04-09 |
| Essure System for Permanent Birth Control (P020014/S051) | Bayer Pharma AG | 2018-04-09 |
| InterStim Therapy System, Verify Evaluation System (P080025/S161) | Medtronic Neuromodulation | 2018-04-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S359) | Medtronic, Inc. | 2018-04-09 |
| Guardian System (P150009) | Avertix Medical, Inc. | 2018-04-09 |
| 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/S662) | Medtronic Cardiac Rhythm Disease Management | 2018-04-09 |
| Wave Light EX500 Laser (P030008/S024) | Alcon Laboratories, Inc. | 2018-04-09 |
| Active Deep Brain Stimulation Therapy System (P960009/S310) | Medtronic, Inc. | 2018-04-09 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S391) | Medtronic Neuromodulation | 2018-04-09 |
| InterStim Therapy System, Verify Evaluation System (P970004/S266) | Medtronic Neuromodulation | 2018-04-09 |
| FlexAbility Catheter, Sensor Enabled (P110016/S056) | ABBOTT MEDICAL | 2018-04-09 |
| Superion Indirect Decompression System (P140004/S011) | Boston Scientific Neuromodulation | 2018-04-09 |
| 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/S620) | Medtronic Cardiac Rhythm Disease Management | 2018-04-09 |
| Ambicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP (N970012/S145) | Boston Scientific Corp | 2018-04-06 |