| Nucleus Auditory Brainstem Implant System (P000015/S030) | Cochlear Americas | 2018-03-02 |
| Birmingham Hip Resurfacing (BHR) System (P040033/S033) | Smith & Nephew, Inc. | 2018-03-02 |
| Nucleus 24 Cochlear Implant System (P970051/S176) | Cochlear Americas | 2018-03-02 |
| Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG (P980035/S533) | Medtronic, Inc. | 2018-03-02 |
| Lotrafilcon A Soft Contact Lenses for Extended Wear (P010019/S063) | Alcon Laboratories, Inc. | 2018-03-02 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S354) | Medtronic, Inc. | 2018-03-02 |
| Ceramic Total Hip System (P070026/S051) | DePuy Orthopaedics, Inc. | 2018-03-02 |
| Sprint Quattro Secure S MRI SureScan Lead & Sprint Quattro Secure MRI SureScan Lead (P920015/S204) | Medtronic, Inc. | 2018-03-01 |
| Primo MRITM SureScan TM & Mirro MRITM SureScan TM (P980016/S653) | Medtronic Cardiac Rhythm Disease Management | 2018-03-01 |
| CapSure Sense MRI SureScan Lead (P830061/S153) | Medtronic Cardiac Rhythm Disease Management | 2018-03-01 |
| Medtronic MiniMed 630G System with Guardian Sensor (3) (P150001/S036) | Medtronic Minimed | 2018-03-01 |
| CapSureFix Novus MRI SureScan Lead (P930039/S179) | Medtronic, Inc. | 2018-03-01 |
| Animas Vibe System (P130007/S033) | Animas Corp. | 2018-03-01 |
| CapSureFix MRI SureScan Lead (P090013/S269) | Medtronic, Inc. | 2018-03-01 |
| SynchroMed Infusion System (P860004/S298) | Medtronic, Inc. | 2018-03-01 |
| GELFOAM (N18286/S028) | Pfizer, Inc. | 2018-03-01 |
| MiniMed 670G System (P160017/S035) | Medtronic Minimed, Inc. | 2018-03-01 |
| Medtronic MiniMed 670G System with Guardian Sensor (3) (P160017/S034) | Medtronic Minimed, Inc. | 2018-03-01 |
| MiniMed 630G System with SmartGuard (P150001/S037) | Medtronic Minimed | 2018-03-01 |
| SelectSecure MRI SureScan Lead (P030036/S098) | Medtronic Cardiac Rhythm Disease Management | 2018-03-01 |
| IsoMed Infusion System (P990034/S038) | Medtronic, Inc. | 2018-03-01 |
| Integra Dermal Regeneration Template (P900033/S065) | Integra Lifesciences Corp. | 2018-03-01 |
| Paradigm real time Revel Insulin Pump (P980022/S203) | Medtronic Minimed | 2018-02-28 |
| Paradigm real time Revel Insulin Pump (P150019/S037) | Medtronic Minimed | 2018-02-28 |
| Arctic Front Advance Cardiac CryoAblation Catheter (P100010/S071) | Medtronic Cryocath, LP | 2018-02-28 |
| INSPIRIS RESILIA Aortic Valve (P150048/S015) | Edwards Lifesciences, LLC | 2018-02-28 |
| MiniMed 530G Insulin Pump (P120010/S111) | Medtronic, Inc. | 2018-02-28 |
| MiniMed 530G Insulin Pump (P120010/S110) | Medtronic, Inc. | 2018-02-28 |
| Paradigm Real Time Revel Insulin Pump (P150019/S036) | Medtronic Minimed | 2018-02-28 |
| Paradigm real time Insulin Pump / Paradigm Real time revel Insulin Pump (P980022/S202) | Medtronic Minimed | 2018-02-28 |
| MiniMed 630G Insulin Pump (P150001/S035) | Medtronic Minimed | 2018-02-28 |
| Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic (P150048/S017) | Edwards Lifesciences, LLC | 2018-02-28 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S005) | W. L. Gore & Associates, Inc. | 2018-02-28 |
| MiniMed 630G System (P150001/S034) | Medtronic Minimed | 2018-02-28 |
| Aptima HPV Assay (P100042/S013) | Gen-Probe Incorporated | 2018-02-28 |
| MiniMed 670G System (P160017/S032) | Medtronic Minimed, Inc. | 2018-02-28 |
| MiniMed 670G System (P160017/S033) | Medtronic Minimed, Inc. | 2018-02-28 |
| Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon (P810031/S064) | Johnson & Johnson Surgical Vision, Inc. | 2018-02-27 |
| Trifecta and Trifecta GT (P100029/S030) | ABBOTT MEDICAL | 2018-02-27 |
| Mechanical Heart Valves and Vlaved Grafts (P810002/S106) | ABBOTT MEDICAL | 2018-02-27 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S007) | Abbott Diabetes Care, Inc. | 2018-02-26 |
| Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S070) | CooperVision, Inc. | 2018-02-26 |
| CardioMEMS HF System (P100045/S028) | ABBOTT MEDICAL | 2018-02-26 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S016) | Abbott Diabetes Care, Inc. | 2018-02-26 |
| Lutonix Drug Coated Balloon (P170003/S001) | Lutonix | 2018-02-26 |
| Aptima HCV Quant Dx Assay (P160023/S001) | Hologic, Inc. | 2018-02-23 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S033) | Ortho-Clinical Diagnostics, Inc. | 2018-02-23 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S037) | Boston Scientific Corporation | 2018-02-23 |
| AspireAssist (P150024/S009) | Aspire Bariatrics, Inc. | 2018-02-23 |
| Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Premier Everolimus-Eluting Pla (P110010/S153) | Boston Scientific Corp | 2018-02-23 |
| CareLink Programmer and Encore Programmer Software (P890003/S384) | Medtronic, Inc. | 2018-02-23 |
| Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S031) | ABBOTT MEDICAL | 2018-02-23 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S011) | Gen-Probe Incorporated | 2018-02-23 |
| QuantiFeron TB Gold and QuantiFeron TB Gold Plus (P010033/S038) | Qiagen | 2018-02-23 |
| SURGICEL Powder Absorbable Hemostatic Powder (N12159/S046) | ETHICON, Inc. | 2018-02-23 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx (P880086/S295) | ABBOTT MEDICAL | 2018-02-22 |
| Microny (P970013/S077) | ABBOTT MEDICAL | 2018-02-22 |
| HeartWare Left Ventricular Assist System (P100047/S117) | Medtronic | 2018-02-22 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S031) | Smith & Nephew, Inc. | 2018-02-22 |
| Durata, Optisure (P950022/S115) | ABBOTT MEDICAL | 2018-02-22 |
| MiniMed 670G Pump (P160017/S030) | Medtronic Minimed, Inc. | 2018-02-22 |
| Current+, Fortify, Fortify Assura, Ellipse (P910023/S403) | ABBOTT MEDICAL | 2018-02-22 |
| MiniMed 630G Pump (P150001/S033) | Medtronic Minimed | 2018-02-22 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead (P960013/S095) | ABBOTT MEDICAL | 2018-02-22 |
| Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF (P030035/S166) | ABBOTT MEDICAL | 2018-02-22 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S029) | Boston Scientific Corp | 2018-02-22 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S025) | ABBOTT MEDICAL | 2018-02-22 |
| Oxford Partial Knee System (P010014/S069) | Biomet Manufacturing Corp | 2018-02-22 |
| therascreen EGFR RGQ PCR kit (P120022/S017) | QIAGEN GmbH | 2018-02-22 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S019) | Abbott Diabetes Care, Inc. | 2018-02-22 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet (MR Conditio (P030054/S348) | ABBOTT MEDICAL | 2018-02-22 |
| IsoFlex Optim (P960030/S056) | ABBOTT MEDICAL | 2018-02-22 |
| Superion Indirect Decompression System (P140004/S009) | Boston Scientific Neuromodulation | 2018-02-22 |
| Juvederm Injectable Gel Implants (P110033/S036) | Allergan | 2018-02-21 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DDR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Protecta ICD, Prot (P980016/S657) | Medtronic Cardiac Rhythm Disease Management | 2018-02-21 |
| Selox ST/JT; Siello S; Setrox S, Solia S, Safio S (P950037/S185) | Biotronik, Inc. | 2018-02-21 |
| digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S037) | Qiagen Gaithersburg, Inc. | 2018-02-21 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar C (P010015/S352) | Medtronic, Inc. | 2018-02-21 |
| 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/S531) | Medtronic, Inc. | 2018-02-21 |
| 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/S617) | Medtronic Cardiac Rhythm Disease Management | 2018-02-21 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S115) | Biotronik, Inc. | 2018-02-21 |
| MULTI-LINK 8 Coronary Stent System and SV/LL Coronary Stent System (P020047/S068) | Abbott Vascular | 2018-02-21 |
| NG3 Cardiac Resynchronization Therapy Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 Cardiac Resynchronization (P010012/S479) | Boston Scientific Corp | 2018-02-21 |
| XIENCE PRIME/SV/LL and XIENCE/SV/LL and XIENCE Alpine and XIENCE Sierra Everolimus Eluting Coronary Stent System (P110019/S097) | Abbott Vascular | 2018-02-21 |
| DIPLOS MODEL 05 A & B (P820076/S026) | Biotronik, Inc. | 2018-02-21 |
| NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per (P960040/S420) | Boston Scientific | 2018-02-21 |
| Juvederm Injectable Gel Implants (P050047/S062) | Allergan | 2018-02-21 |
| Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI (P070008/S089) | Biotronik, Inc. | 2018-02-21 |
| XIENCE V Everolimus Eluting Coronary Stent System (P070015/S140) | Abbott Vascular, Inc. | 2018-02-21 |
| Protego SD/TD/S/T; Protego DF-1 SD/DF-1S; Protego ProMRI SDX/DF-1 ProMRI SDX; Protego DF-1 ProMRI SD/DF-1 ProMRI S; Plex (P980023/S084) | Biotronik, Inc. | 2018-02-21 |
| WATCHMAN Left Atrial Appendage Closure Technology (P130013/S017) | Boston Scientific Corp | 2018-02-21 |
| Micra TPS MC1VR01 (P150033/S031) | Medtronic, Inc. | 2018-02-21 |
| Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S048) | W. L. Gore & Associates, Inc. | 2018-02-20 |
| Cobas HCV Test (P150015/S012) | Roche Molecular Systems, Inc. | 2018-02-20 |
| NeuroPace RNS System (P100026/S053) | NeuroPace, Inc. | 2018-02-20 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S109) | W. L. Gore & Associates, Inc. | 2018-02-20 |
| Cobas HBV Test (P150014/S013) | Roche Molecular Systems, Inc. | 2018-02-20 |
| Cobas CMV Test (P160041/S005) | Roche Molecular Systems, Inc. | 2018-02-20 |
| Impella RP System (P170011/S002) | Abiomed, Inc. | 2018-02-16 |
| PROMUS Element Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent (P110010/S152) | Boston Scientific Corp | 2018-02-16 |