| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S007) | Siemens Healthcare Diagnostics, Inc. | 2019-03-08 |
| methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S080) | CooperVision, Inc. | 2019-03-08 |
| Atellica IM Hepatitis B orfe IgM (aHBcM) Assay (P030040/S015) | Siemens Healthcare Diagnostics | 2019-03-08 |
| InterStim Therapy System, Verify Evaluation System (P970004/S282) | Medtronic Neuromodulation | 2019-03-08 |
| Aptima HBV Quant Assay (P170025/S008) | Hologic, Inc. | 2019-03-08 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S010) | Siemens Healthcare Diagnostics, Inc. | 2019-03-07 |
| Visian Toric ICL (IMPLANTABLE COLLAMER LENS) (P030016/S034) | STAAR Surgical Company | 2019-03-07 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S022) | Medtronic Vascular | 2019-03-07 |
| Prometra Programmable Infusion Pump System (P080012/S055) | Infusyn Therapeutics, LLC | 2019-03-07 |
| LCS Total Knee System (P830055/S224) | Depuy, Inc. | 2019-03-07 |
| Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S012) | Boston Scientific Corp | 2019-03-07 |
| Restylane Injectable Gels (P040024/S107) | Q-Med AB | 2019-03-07 |
| CardioMEMS HF System (P100045/S037) | ABBOTT MEDICAL | 2019-03-07 |
| TRANSCEND Hip Articulation System (P010001/S019) | Ceramtec GmbH | 2019-03-06 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S066) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Micra TPS (P150033/S049) | Medtronic, Inc. | 2019-03-06 |
| BRACAnalysis CDx (P140020/S014) | Myriad Genetic Laboratories | 2019-03-06 |
| GORE Carotid Stent (P180010/S003) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S127) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls (P050051/S033) | Abbott Laboratories, Inc. | 2019-03-06 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG; Azure S DR MRI IPG, Azure S SR MRI IP (P980035/S578) | Medtronic, Inc. | 2019-03-06 |
| Inspire Upper Airway Stimulator (P130008/S040) | Inspire Medical Systems | 2019-03-06 |
| GORE TIGRIS Vascular Stent (P160004/S025) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (P010015/S393) | Medtronic, Inc. | 2019-03-06 |
| Angio-Seal Vascular Closure Devices (P930038/S091) | Terumo Medical Corporation | 2019-03-06 |
| Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls (P080023/S028) | Abbott Laboratories | 2019-03-06 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S017) | W. L. Gore & Associates, Inc. | 2019-03-06 |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S003) | Rxsight, Inc. | 2019-03-06 |
| Praxis Extended RAS Panel (P160038/S009) | Illumina, Inc. | 2019-03-05 |
| Ascension MCP (P000057/S011) | Smith & Nephew, Inc. | 2019-03-05 |
| Sprint Quattro Secure and Sprint Quattro Secure S (P920015/S225) | Medtronic, Inc. | 2019-03-05 |
| Implantable Cardioverter Defibrillator ICDs (P980049/S134) | MicroPort CRM USA, Inc. | 2019-03-05 |
| AMPLATZER Duct Occluder, Occluder II; AMPLATZER Piccolo Occluder (P020024/S055) | ABBOTT MEDICAL | 2019-03-05 |
| AMPLATZER PFO Occluder (P120021/S010) | ABBOTT MEDICAL | 2019-03-05 |
| TactiCatch Quartz Contact Force Ablation Catheter (P130026/S042) | St Jude Medical | 2019-03-05 |
| AMPLATZER Muscular VSD Occluder (P040040/S035) | ABBOTT MEDICAL | 2019-03-05 |
| Livewire TC Cables; Safire Ablation Catheter; Safire Cable (P960016/S077) | St Jude Medical | 2019-03-05 |
| FlexAbility and FlexAbility SE Ablation Catheter; FlexAbility Cables, Sensor Enabled (P110016/S059) | ABBOTT MEDICAL | 2019-03-05 |
| Secura DR ICD, Maximo II DR ICD, Protecta XT DR ICD, Protecta DR ICD, Secura VR ICD, Maximo II VR ICD, Protecta XT VR IC (P980016/S698) | Medtronic Cardiac Rhythm Disease Management | 2019-03-05 |
| AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S064) | ABBOTT MEDICAL | 2019-03-05 |
| HEMOBLAST Bellows (P170012/S014) | Dilon Technologies, Inc. | 2019-03-05 |
| Oncomine Dx Target Test (P160045/S014) | Life Technologies Corporation | 2019-03-05 |
| Arctic Front Advance Cardiac Cryoablation Catheter (P100010/S088) | Medtronic Cryocath, LP | 2019-03-05 |
| Consulta CRT-D, Maximo II CRT-D, Protecta XT CRT-D and Protecta CRT-D (P010031/S658) | Medtronic Cardiac Rhythm Disease Management | 2019-03-05 |
| Cardiac Resynchronization Therapy Defibrillator (P060027/S099) | MicroPort CRM USA, Inc. | 2019-03-05 |
| Medtronic CareLink Monitor, CardioSight Reader (P890003/S403) | Medtronic, Inc. | 2019-03-05 |
| Trifecta/Trifecta GT Valves (P100029/S038) | ABBOTT MEDICAL | 2019-03-04 |
| Floseal Hemostatic Matrix (P990009/S051) | Baxter Healthcare Corp | 2019-03-04 |
| Innova Vascular Self-Expanding Stent System (P140028/S037) | Boston Scientific Corporation | 2019-03-04 |
| RxSight Light Adjustable Lens (LAL) and Light Delivery Device (P160055/S002) | Rxsight, Inc. | 2019-03-04 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S040) | Abbott Diabetes Care, Inc. | 2019-03-04 |
| Innova Vascular Self-Expanding Stent System (P140028/S038) | Boston Scientific Corporation | 2019-03-04 |
| Biocor/Epic Valves (P040021/S039) | ABBOTT MEDICAL | 2019-03-04 |
| FreeStyle Libre 14day Flash Glucose Monitoring System (P160030/S032) | Abbott Diabetes Care, Inc. | 2019-03-04 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S005) | Heartsine Technologies, Ltd. | 2019-03-04 |
| Hancock Valved Conduit LP (P790007/S060) | Medtronic Heart Valves | 2019-03-03 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S187) | Edwards Lifesciences, LLC | 2019-03-03 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S080) | Edwards Lifesciences, LLC | 2019-03-03 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S031) | Edwards Lifesciences, LLC | 2019-03-03 |
| Mosaic Porcine Bioprosthetic Heart Valve (P990064/S078) | Medtronic, Inc. | 2019-03-03 |
| Freestyle Aortic Root Bioprosthesis (P970031/S065) | Medtronic, Inc. | 2019-03-03 |
| Hancock II Porcine Bioprosthesis (P980043/S070) | Medtronic, Inc. | 2019-03-03 |
| Impella CP with SmartAssist (P140003/S046) | Abiomed, Inc. | 2019-03-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S096) | Edwards Lifesciences, LLC | 2019-03-03 |
| EDWARDS INTUITY Elite Valve System (P150036/S037) | Edwards Lifesciences, LLC | 2019-03-03 |
| Hancock Valved Conduit MO (P870078/S045) | Medtronic, Inc. | 2019-03-03 |
| Avalus Bioprosthesis (P170006/S010) | Medtronic, Inc. | 2019-03-03 |
| Covera Vascular Covered Stent (P170042/S002) | C.R. Bard, Inc. | 2019-03-01 |
| LifeVest Wearable Defibrillator (P010030/S115) | Zoll Manufacturing Corporation | 2019-03-01 |
| Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S025) | Boston Scientific Corp | 2019-03-01 |
| Spiration Valve System (P180007/S002) | Gyrus Acmi, Inc. | 2019-03-01 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S073) | Hologic, Inc. | 2019-03-01 |
| Obalon Balloon System with Navigation and Touch (P160001/S032) | Medtimo, Inc. | 2019-03-01 |
| Activa Deep Brain Stimulation Therapy System (P960009/S336) | Medtronic, Inc. | 2019-03-01 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S028) | Tandem Diabetes Care, Inc. | 2019-03-01 |
| CareLink SmartSync Azure Astra App and Azure Astra DR/SR/XT MRI SureScan IPGs (P980035/S536) | Medtronic, Inc. | 2019-02-28 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S018) | Gen-Probe Incorporated | 2019-02-28 |
| Fineline II Sterox, EZ. (P960004/S088) | Boston Scientific | 2019-02-28 |
| LifeVest Wearable Defibrillator (P010030/S111) | Zoll Manufacturing Corporation | 2019-02-28 |
| Emblem S-ICD, Electrode (P110042/S120) | Boston Scientific Corporation | 2019-02-28 |
| Acuity X4 Leads, Acuity Spiral Leads (P010012/S494) | Boston Scientific Corp | 2019-02-28 |
| SofPort Posterior Chamber Intraocular Lenses (P910061/S025) | Bausch & Lomb | 2019-02-28 |
| Aptima HPV Assay (P100042/S020) | Gen-Probe Incorporated | 2019-02-28 |
| Aptima HCV Quant Dx Assay (P160023/S009) | Hologic, Inc. | 2019-02-28 |
| Reliance 4-Front, 4-Site IS-1 Defibrillation (P910073/S153) | Boston Scientific | 2019-02-28 |
| Aptima HBV Quant Assay (P170025/S007) | Hologic, Inc. | 2019-02-28 |
| Propel Contour Sinus Implant (P100044/S037) | Intersect Ent. | 2019-02-28 |
| Ingevity MRI (P150012/S070) | Boston Scientific | 2019-02-28 |
| Optune System (P100034/S022) | Novocure, GmbH | 2019-02-28 |
| PMMA Posterior Chamber Intraocular Lenses (P840039/S063) | Bausch & Lomb, Inc. | 2019-02-28 |
| PMMA Anterior Chamber Intraocular Lenses (P880090/S030) | Bausch & Lomb, Inc. | 2019-02-28 |
| CareLink SmartSync Base, Patient Connector, Host App, PSA App, Common App, and CareLink SmartSync Platform App (P890003/S386) | Medtronic, Inc. | 2019-02-28 |
| LifeVest Wearable Defibrilator (P010030/S107) | Zoll Manufacturing Corporation | 2019-02-27 |
| On-X Prosthetic Heart Valve (P000037/S053) | On-X Life Technologies, Inc. | 2019-02-26 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S037) | Abbott Diabetes Care, Inc. | 2019-02-26 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S090) | CooperVision, Inc. | 2019-02-26 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S029) | Abbott Diabetes Care, Inc. | 2019-02-26 |
| Biocor Valve, Supra Valve; Epic Valve, Supra (P040021/S038) | ABBOTT MEDICAL | 2019-02-26 |
| Praxis Extended RAS Panel (P160038/S008) | Illumina, Inc. | 2019-02-25 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S041) | St Jude Medical | 2019-02-25 |