| CoreValve Evolut R, PRO Bioprosthesis (P130021/S055) | Medtronic, Inc. | 2018-11-09 |
| Arctic Front Advance and Arctic Front Advance Pro Cardiac Cryoablation Catheters (P100010/S084) | Medtronic Cryocath, LP | 2018-11-09 |
| HV Splitter/Adaptor Kit, Sprint Quattro Lead. (P920015/S219) | Medtronic, Inc. | 2018-11-09 |
| Infuse Bone Graft/medtronic Interbody Fusion Devise (P000058/S070) | Medtronic Sofamor Danek USA, Inc. | 2018-11-09 |
| ARCHITECT CORE (LN 6L22) (P080023/S030) | Abbott Laboratories | 2018-11-09 |
| Infuse Bone Graft (P000054/S051) | Medtronic Sofamor Danek USA, Inc. | 2018-11-09 |
| MISAGO RX self-expanding Peripheral stent (P140002/S018) | Terumo Medical Corporation | 2018-11-09 |
| LINX Reflux Management System (P100049/S025) | Torax Medical | 2018-11-09 |
| AspireAssist (P150024/S008) | Aspire Bariatrics, Inc. | 2018-11-09 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S413) | Medtronic Neuromodulation | 2018-11-08 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S410) | Medtronic Neuromodulation | 2018-11-08 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S020) | Bolton Medical, Inc. | 2018-11-08 |
| Deflux Injectable Gel (P000029/S083) | Palette Life Sciences | 2018-11-08 |
| Activa Deep Brian Stimulation Therapy System (P960009/S327) | Medtronic, Inc. | 2018-11-08 |
| Solesta Injectable Gel (P100014/S020) | Palette Life Sciences | 2018-11-08 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S031) | Cook Ireland, Ltd. | 2018-11-08 |
| Activa Deep Brain Stimulation Therapy System (P960009/S329) | Medtronic, Inc. | 2018-11-08 |
| SURGICEL Absorbable Hemostat (N12159/S050) | ETHICON, Inc. | 2018-11-08 |
| Durata, Optisure, (P950022/S122) | ABBOTT MEDICAL | 2018-11-07 |
| Tendril MRI (P140033/S039) | ABBOTT MEDICAL | 2018-11-07 |
| Obalon Touch Dispenser (P160001/S025) | Medtimo, Inc. | 2018-11-07 |
| QuickFlex u, Quartet (P030054/S361) | ABBOTT MEDICAL | 2018-11-07 |
| Tendrill SDX, OptiSense, Tendrill STS, Tendril ST. (P960013/S102) | ABBOTT MEDICAL | 2018-11-07 |
| Obalon Touch Dispenser (P160001/S026) | Medtimo, Inc. | 2018-11-07 |
| Obalon Touch Dispenser (P160001/S024) | Medtimo, Inc. | 2018-11-07 |
| Architect Anti-HCV Regent Kit (100, 500 Test) (P050042/S036) | Abbott Laboratories, Inc. | 2018-11-07 |
| CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery (P840062/S070) | Integra Lifesciences Corp. | 2018-11-07 |
| Isoflex (P960030/S061) | ABBOTT MEDICAL | 2018-11-07 |
| Elecsys Anti-HBc II (P100032/S019) | Roche Diagnostics Corp. | 2018-11-06 |
| Elecsys Anti-HBc II (P100031/S025) | Roche Diagnostics Corp. | 2018-11-06 |
| PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System (P160003/S005) | Biotronik AG | 2018-11-06 |
| Elecsys ANti-HBs (P010054/S039) | Roche Diagnostics Corp. | 2018-11-06 |
| Elecsys HBsAg II (100/200 tests) (P160019/S008) | Roche Diagnostics, Inc. | 2018-11-06 |
| Elecsys HBeAg (P130015/S016) | Roche Diagnostics Operations, Inc. | 2018-11-06 |
| Elecsys Anti-HBc IgM (P110022/S026) | Roche Diagnostics Corp. | 2018-11-06 |
| Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse (P160048/S002) | Senseonics, Incorporated | 2018-11-06 |
| Cardioform Septal Occluder (P050006/S069) | W. L. Gore & Associates, Inc. | 2018-11-06 |
| 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/S686) | Medtronic Cardiac Rhythm Disease Management | 2018-11-06 |
| Elecsys ANti-HCV II (100/200 tests) (P140021/S015) | Roche Diagnostics Operations, Inc. | 2018-11-06 |
| Elecsys Anti-HBc IgM (P110031/S023) | Roche Diagnostics Corp. | 2018-11-06 |
| 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/S645) | Medtronic Cardiac Rhythm Disease Management | 2018-11-06 |
| enVista Hydrophobic Acrylic Intraocular Lens (P910056/S035) | Bausch & Lomb, Inc. | 2018-11-06 |
| CardioMEMS HF System (P100045/S033) | ABBOTT MEDICAL | 2018-11-06 |
| AngioJet Rheolytic Thrombectomy System (P980037/S071) | Boston Scientific Corp | 2018-11-06 |
| Elecsys Anti-HBc IgM (P110025/S022) | Roche Diagnostics Corp. | 2018-11-06 |
| Codman 3000 Series Constant-Flow Implantable Infusion Pump - Tapered Catheter (IP-37957) (P890055/S072) | Intera Oncology | 2018-11-06 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP (MR Conditi (P030054/S363) | ABBOTT MEDICAL | 2018-11-05 |
| Edwards Pericardial Mitral Bioprosthesis (P150048/S026) | Edwards Lifesciences, LLC | 2018-11-05 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional) (P910023/S413) | ABBOTT MEDICAL | 2018-11-05 |
| Remede® System (P160039/S002) | Respicardia | 2018-11-02 |
| Paradigm REAL-Time Revel Insulin Pump (P150019/S047) | Medtronic Minimed | 2018-11-02 |
| Restylane Lyft with Lidocaine Cannula Injection (P040024/S101) | Q-Med AB | 2018-11-02 |
| MiniMed 530G Insulin Pump (P120010/S121) | Medtronic, Inc. | 2018-11-02 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S051) | Ahp Eos Buyer, Inc. | 2018-11-02 |
| Paradigm REAL-Time Insulin Pump (P980022/S206) | Medtronic Minimed | 2018-11-02 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S062) | Ahp Eos Buyer, Inc. | 2018-11-02 |
| Synvisc and Synvisc-One (P940015/S041) | Sanofi Genzyme Corp. | 2018-11-02 |
| Epic Vascular Self-Expanding Stent System (P110035/S048) | Boston Scientific Corp | 2018-11-01 |
| Gore Carotid Stent (P180010) | W. L. Gore & Associates, Inc. | 2018-11-01 |
| AcrySof Intraocular Lenses (P930014/S116) | Alcon Laboratories, Inc. | 2018-11-01 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S037) | Boston Scientific Corp | 2018-11-01 |
| Inspire Model 2740 Physician Programmer (P130008/S034) | Inspire Medical Systems | 2018-11-01 |
| BioGlue Surgical Adhesive (P010003/S031) | Cryolife, Inc. | 2018-11-01 |
| Therakos CELLEX Procedural Kit (P860003/S099) | Therakos Development Limited | 2018-11-01 |
| AcrySof ReSTOR Intraocular Lenses (P040020/S084) | Alcon Research, Ltd. | 2018-11-01 |
| Tendril MRI Lead (P140033/S040) | ABBOTT MEDICAL | 2018-10-31 |
| Aptima HBV Quant Assay (P170025/S005) | Hologic, Inc. | 2018-10-31 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S381) | Medtronic, Inc. | 2018-10-31 |
| Aptima HCV Quant DX Assay (P160023/S007) | Hologic, Inc. | 2018-10-31 |
| 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/S648) | Medtronic Cardiac Rhythm Disease Management | 2018-10-31 |
| 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/S689) | Medtronic Cardiac Rhythm Disease Management | 2018-10-31 |
| Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System (P160030/S010) | Abbott Diabetes Care, Inc. | 2018-10-31 |
| Aptima HCV RNA Qualitative Assay (P020011/S011) | Gen-Probe | 2018-10-31 |
| Left Heart Leads (QuickFlex u and Quartet) (P030054/S362) | ABBOTT MEDICAL | 2018-10-31 |
| Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (P980035/S565) | Medtronic, Inc. | 2018-10-31 |
| enVista One Piece Hydrophobic Acrylic Intraocular LEns (IOL) (P910056/S034) | Bausch & Lomb, Inc. | 2018-10-31 |
| LIFEPAK Automated External Defibrillatorts (AEDs) (P160026/S002) | Physio-Control, Inc. | 2018-10-31 |
| Isoflex Low Voltage Leads (P960030/S062) | ABBOTT MEDICAL | 2018-10-31 |
| Tendril and OptiSense Low Voltage Leads (P960013/S103) | ABBOTT MEDICAL | 2018-10-31 |
| Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S056) | Boston Scientific Corp | 2018-10-31 |
| Wolverine Coronary Cutting Balloon Monorail Over The Wire (P950020/S091) | Boston Scientific Corp | 2018-10-31 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S160) | Boston Scientific Corp | 2018-10-31 |
| Durata and Optisure High Voltage Leads (P950022/S123) | ABBOTT MEDICAL | 2018-10-31 |
| Micra TPS (P150033/S043) | Medtronic, Inc. | 2018-10-31 |
| QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test (P010033/S041) | Qiagen | 2018-10-30 |
| Melody TPV System (P140017/S011) | Medtronic, Inc. | 2018-10-30 |
| Oncomine Dx Target Test (P160045/S010) | Life Technologies Corporation | 2018-10-30 |
| Cologuard (P130017/S024) | Exact Sciences Corporation | 2018-10-29 |
| Hancock Valved Conduit Low Porosity (P870078/S043) | Medtronic, Inc. | 2018-10-28 |
| Melody (P140017/S012) | Medtronic, Inc. | 2018-10-28 |
| Hancock Valved Conduit Modified Orifice (P790007/S058) | Medtronic Heart Valves | 2018-10-28 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S027) | Tandem Diabetes Care, Inc. | 2018-10-26 |
| WaveLight EX500 Excimer Laser System (P030008/S027) | Alcon Laboratories, Inc. | 2018-10-26 |
| Evera MRI, ICD, DF-1 ICD, S DR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD, VR ICD; Visia AF M (P980016/S690) | Medtronic Cardiac Rhythm Disease Management | 2018-10-26 |
| WaveLight EX500 Excimer Laser System (P020050/S031) | Alcon Laboratories, Inc. | 2018-10-26 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S006) | Tandem Diabetes Care, Inc. | 2018-10-26 |
| Amplia MRI CRT-D, Quad CRT -D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, MRI Quad CRT-D; (P010031/S647) | Medtronic Cardiac Rhythm Disease Management | 2018-10-26 |
| Zoll X Series Device (Oridion MicroMediCO2) (P160022/S004) | ZOLL Medical Corporation | 2018-10-26 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S004) | Berlin Heart, Inc. | 2018-10-26 |
| BRACAnalysis CDx (P140020/S017) | Myriad Genetic Laboratories | 2018-10-25 |