| ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Cathete (P040036/S064) | Biosense Webster, Inc. | 2019-03-26 |
| CapSureFix MRI Lead (P090013/S296) | Medtronic, Inc. | 2019-03-26 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG, DR MRI IPG, SR MRI IPG; Astra S DR MRI IPG, S SR MRI IPG, XT DR MRI IPG, XT SR (P980035/S577) | Medtronic, Inc. | 2019-03-26 |
| HeartWare Left Ventricular Assist Device System (P100047/S137) | Medtronic | 2019-03-26 |
| Evera: MRI DF-1 ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, MRI VR ICD; Primo MRI DR ICD, (P980016/S699) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| Adhesive, CapSure Sense Lead, CapSure SP Novvus Lead Stylet Kit and Vitatron Crystalline Lead (P830061/S167) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S037) | The Cooper Companies | 2019-03-26 |
| INCRAFT AAA Stent Graft System (P150002/S001) | Cordis US Corporation | 2019-03-26 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug, Lead Adaptor, Sprint Quattro Lead, H (P920015/S226) | Medtronic, Inc. | 2019-03-26 |
| BD Onclarity HPV Assay, BD Viper LT System (P160037/S001) | Becton, Dickinson and Company | 2019-03-26 |
| Attain Ability Lead and Attain Performa Lead (P080006/S131) | Medtronic, Inc. | 2019-03-26 |
| CardioMEMS HF System (P100045/S039) | ABBOTT MEDICAL | 2019-03-26 |
| Drug Delivery Catheter (P140032/S029) | Medtronic, Inc. | 2019-03-26 |
| CapSureFIx Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S196) | Medtronic, Inc. | 2019-03-26 |
| ThermoCool SmartTouch Bi-Directional Navigation Catheter; ThermoCool SmartTouch Uni-Directional Navigation Catheter (P030031/S094) | Biosense Webster, Inc. | 2019-03-26 |
| Axium Neurostimulator System (P150004/S023) | ABBOTT MEDICAL | 2019-03-26 |
| Transvene CS/SVS Lead (P980050/S121) | Medtronic, Inc. | 2019-03-26 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit and Vitatron Impulse II Lead (P850089/S140) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S032) | Cook Ireland, Ltd. | 2019-03-26 |
| EXOSEAL Vascular Closure Device (P100013/S018) | Cordis US Corporation | 2019-03-26 |
| Attain StarFix Lead (P060039/S093) | Medtronic, Inc. | 2019-03-26 |
| ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve (P900061/S152) | Medtronic Cardiac Rhythm Disease Management | 2019-03-26 |
| Amplatzer Patent FOramen Ovale Occluder (P120021/S011) | ABBOTT MEDICAL | 2019-03-25 |
| Praxis Extended RAS Panel (P160038/S010) | Illumina, Inc. | 2019-03-25 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder (P020024/S056) | ABBOTT MEDICAL | 2019-03-25 |
| Biocor and Epic Valves (P040021/S040) | ABBOTT MEDICAL | 2019-03-25 |
| Amplatzer Muscular VSD Occluder (P040040/S036) | ABBOTT MEDICAL | 2019-03-25 |
| St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft (P810002/S109) | ABBOTT MEDICAL | 2019-03-25 |
| Trifecta and Trifecta GT surgical Heart Valve (P100029/S039) | ABBOTT MEDICAL | 2019-03-25 |
| Amplatzer Septal Occluder and Amplatzer Cribriform Occluder (P000039/S065) | ABBOTT MEDICAL | 2019-03-25 |
| GORE CARDIOFORM Septal Occuluder (P050006/S073) | W. L. Gore & Associates, Inc. | 2019-03-25 |
| LIFEPAK 15 monitor/defibrillator (P160026/S004) | Physio-Control, Inc. | 2019-03-24 |
| Activa Deep Brain Stimulation Therapy System (P960009/S340) | Medtronic, Inc. | 2019-03-22 |
| Implantable Miniature Telescope (IMT) (P050034/S020) | Samsara Vision, Inc. | 2019-03-22 |
| HiResolution Bionic Ear System (P960058/S138) | Advanced Bionics | 2019-03-22 |
| RHA 2, RHA 3, and RHA 4 dermal fillers (P170002/S002) | Teoxane S.A. | 2019-03-22 |
| FLOSEAL Hemostatic Matrix (P990009/S052) | Baxter Healthcare Corp | 2019-03-22 |
| Cartiva Synthetic Cartilage Implant (P150017/S012) | Cartiva, Inc. | 2019-03-22 |
| GORE VIABAHN Endoprosthesis (P040037/S123) | W. L. Gore & Associates, Inc. | 2019-03-22 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S062) | W. L. Gore & Associates, Inc. | 2019-03-22 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S283) | Medtronic Neuromodulation | 2019-03-22 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S421) | Medtronic Neuromodulation | 2019-03-22 |
| (lotrafilcon A) Soft Contact Lenses for Daily and Extended Wear (P010019/S071) | Alcon Laboratories, Inc. | 2019-03-22 |
| Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S027) | Cerenovus, Inc. | 2019-03-22 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S178) | Medtronic Neuromodulation | 2019-03-22 |
| Guardian Link (3) Transmitter (MiniMed 630G System with SmartGuard) (P150001/S062) | Medtronic Minimed | 2019-03-21 |
| Aptima HCV RNA Qualitative Assay (P020011/S012) | Gen-Probe | 2019-03-21 |
| Aptima HCV Quant Dx Assay (P160023/S010) | Hologic, Inc. | 2019-03-21 |
| Guardian Connect Transmitter (P160007/S016) | Medtronic Minimed | 2019-03-21 |
| Consulta CRT-P; Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P; Serena Bipolar CRT-P, Serena Quadripolar CRT-P; Sola (P010015/S395) | Medtronic, Inc. | 2019-03-21 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S067) | W. L. Gore & Associates, Inc. | 2019-03-21 |
| X Series/Propaq MD (P160022/S009) | ZOLL Medical Corporation | 2019-03-21 |
| Adapta, Versa, Sensia IPG; Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG; Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S579) | Medtronic, Inc. | 2019-03-21 |
| Amplia MRI CRT-D, Amplia Quad CRT-D; Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI (P010031/S660) | Medtronic Cardiac Rhythm Disease Management | 2019-03-21 |
| Aptima HBV Quant Assay (P170025/S009) | Hologic, Inc. | 2019-03-21 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S070) | W. L. Gore & Associates, Inc. | 2019-03-21 |
| Angio-Seal Vascular Closure Devices (P930038/S092) | Terumo Medical Corporation | 2019-03-21 |
| Aptima HPV Assay (P100042/S021) | Gen-Probe Incorporated | 2019-03-21 |
| Guardian Link (3) Transmitter (MiniMed 670G System) (P160017/S058) | Medtronic Minimed, Inc. | 2019-03-21 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S025) | Medtronic Vascular, Inc. | 2019-03-21 |
| 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/S700) | Medtronic Cardiac Rhythm Disease Management | 2019-03-21 |
| OPTIMIZER Smart System (P180036) | Impulse Dynamics (Usa), Inc. | 2019-03-21 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S008) | Celonova Biosciences, Inc. | 2019-03-21 |
| GORE VIABAHN Endoprosthesis (P040037/S128) | W. L. Gore & Associates, Inc. | 2019-03-21 |
| Zilver Vascular Stent (P050017/S017) | Cook Ireland, Ltd. | 2019-03-21 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S016) | Corcym S.r.l. | 2019-03-20 |
| Solo Smart Heart Valve (P130011/S007) | Corcym Canada Corp | 2019-03-20 |
| Impella 2.5 (P140003/S048) | Abiomed, Inc. | 2019-03-20 |
| CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters (P910001/S109) | Spectranetics Corp. | 2019-03-20 |
| CardioMEMS HF System (P100045/S038) | ABBOTT MEDICAL | 2019-03-20 |
| Implantable System for Remodulin (P140032/S027) | Medtronic, Inc. | 2019-03-20 |
| Ophthalmic Viscosurgical Devices (P840064/S070) | Alcon Laboratories | 2019-03-20 |
| Edwards SAPIEN 3 (XT) Transcatheter Heart Valves (P130009/S097) | Edwards Lifesciences, LLC | 2019-03-19 |
| PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; (P980049/S133) | MicroPort CRM USA, Inc. | 2019-03-19 |
| Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S038) | Abbott Diabetes Care, Inc. | 2019-03-19 |
| Wolverine Coronary Cutting Balloon (P950020/S096) | Boston Scientific Corp | 2019-03-19 |
| Cologuard (P130017/S028) | Exact Sciences Corporation | 2019-03-19 |
| Edwards SAPIEN 3, SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S082) | Edwards Lifesciences, LLC | 2019-03-19 |
| PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; (P060027/S098) | MicroPort CRM USA, Inc. | 2019-03-19 |
| Vercise, Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S015) | Boston Scientific Corp | 2019-03-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S083) | Edwards Lifesciences, LLC | 2019-03-19 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S005) | Boston Scientific Corp | 2019-03-18 |
| GORE TAG Thoracic Endoprosthesis (P040043/S109) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE TIGRIS Vascular Stent (P160004/S026) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE CARDIOFORM Septal Occluder (P050006/S074) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE Carotid Stent (P180010/S004) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S129) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S019) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S068) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis Manufacturing Expansion (P160021/S018) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S071) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S163) | W. L. Gore & Associates, Inc. | 2019-03-18 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S076) | Integra Lifesciences Corp. | 2019-03-15 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S080) | Dexcom, Inc. | 2019-03-15 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent- Microfibrillar Form (P810006/S084) | Integra LifeSciences Corporation | 2019-03-15 |
| Activa Deep Brain Stimulation Therapy System (P960009/S339) | Medtronic, Inc. | 2019-03-15 |
| TB Gold and QuantiFERON - TB Gold Plus (P010033/S043) | Qiagen | 2019-03-15 |
| Progensa PCA3 Assay (P100033/S010) | Gen-Probe Incorporated | 2019-03-15 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S006) | Celonova Biosciences, Inc. | 2019-03-15 |
| Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form (P850010/S084) | Integra LifeSciences Corporation | 2019-03-15 |