| Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S039) | Abbott Diabetes Care, Inc. | 2020-05-12 |
| Mechanical Heart Valve (P810002/S111) | ABBOTT MEDICAL | 2020-05-12 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S046) | Abbott Diabetes Care, Inc. | 2020-05-12 |
| Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate) (P110007/S012) | Johnson & Johnson Surgical Vision, Inc. | 2020-05-11 |
| SelectSecure Lead (P030036/S120) | Medtronic Cardiac Rhythm Disease Management | 2020-05-11 |
| Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D), Implantable Cardioverter Defib (P050023/S139) | Biotronik, Inc. | 2020-05-11 |
| Defibrillator, Implantable Dual-Chamber (P000009/S082) | Biotronik, Inc. | 2020-05-11 |
| Pulse Generator, Permanent, Implantable (P950037/S207) | Biotronik, Inc. | 2020-05-11 |
| HeartStart FRx Defibrillator (P180028) | Philips Medical Systems | 2020-05-11 |
| Philips HeartStart FR3 Defibrillator (P160028) | Philips Medical Systems, Inc. | 2020-05-11 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S096) | Biotronik, Inc. | 2020-05-11 |
| Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack (P810031/S067) | Johnson & Johnson Surgical Vision, Inc. | 2020-05-11 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P070008/S110) | Biotronik, Inc. | 2020-05-11 |
| Visia AF MRI DF1 ICD, Visia AF MRI VR ICD, and Visia AF VR ICD (P980016/S731) | Medtronic Cardiac Rhythm Disease Management | 2020-05-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S205) | Medtronic Neuromodulation | 2020-05-08 |
| Implantable System for Remodulin (P140032/S053) | Medtronic, Inc. | 2020-05-08 |
| prodisc L Total Disc Replacement (P050010/S021) | Centinel Spine, LLC | 2020-05-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S310) | Medtronic Neuromodulation | 2020-05-08 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S356) | Medtronic, Inc. | 2020-05-08 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad (P010031/S692) | Medtronic Cardiac Rhythm Disease Management | 2020-05-08 |
| prodisc C Total Disc Replacement (P070001/S018) | Centinel Spine, LLC | 2020-05-08 |
| myChoice CDx (P190014/S003) | Myriad Genetic Laboratories, Inc. | 2020-05-08 |
| Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S461) | Medtronic Neuromodulation | 2020-05-08 |
| Activa Deep Brain Stimulation Therapy System (P960009/S374) | Medtronic, Inc. | 2020-05-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S429) | Medtronic, Inc. | 2020-05-08 |
| HeartLight Endoscopic Ablation System (P150026/S008) | Cardiofocus, Inc. | 2020-05-08 |
| 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 IPG (P980035/S618) | Medtronic, Inc. | 2020-05-08 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S309) | Medtronic Neuromodulation | 2020-05-07 |
| Activa Deep Brain Stimulation Therapy System (P960009/S373) | Medtronic, Inc. | 2020-05-07 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stimu (P840001/S460) | Medtronic Neuromodulation | 2020-05-07 |
| HeartWare HVAD System (P100047/S142) | Medtronic | 2020-05-07 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S204) | Medtronic Neuromodulation | 2020-05-07 |
| Proclaim family of SCS IPGs (P010032/S160) | ABBOTT MEDICAL | 2020-05-06 |
| HeartWare Ventricular Assist System (P100047/S161) | Medtronic | 2020-05-06 |
| Proclaim DRG IPG (P150004/S035) | ABBOTT MEDICAL | 2020-05-06 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S036) | ABBOTT MEDICAL | 2020-05-06 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S161) | ABBOTT MEDICAL | 2020-05-06 |
| SLS/GlideLight (P960042/S069) | Spectranetics (Philips) | 2020-05-06 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S057) | ABBOTT MEDICAL | 2020-05-06 |
| Infinity DBS IPGs (P140009/S056) | ABBOTT MEDICAL | 2020-05-06 |
| EXCOR blood pumps with Injection Molded Housing (P160035/S014) | Berlin Heart, Inc. | 2020-05-06 |
| Mara Water Vapor Ablation System (P160047/S010) | CooperSurgical, Inc. | 2020-05-06 |
| FoundationOne CDx (F1CDx) (P170019/S011) | Foundation Medicine, Inc. | 2020-05-06 |
| Hancock II Bioprothesis (P980043/S073) | Medtronic, Inc. | 2020-05-06 |
| Artegraft Collagen Vascular Graft (N16837/S026) | LeMaitre Vascular, Inc. | 2020-05-06 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S061) | Boston Scientific Corporation | 2020-05-06 |
| Tula SystemTube Delivery System (TDS) (P190016/S001) | Tusker Medical, Inc. | 2020-05-06 |
| Alinity m HCV (P190025/S001) | Abbott Molecular, Inc. | 2020-05-06 |
| Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S178) | Boston Scientific Corp | 2020-05-06 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S055) | Boston Scientific Corporation | 2020-05-05 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S078) | Boston Scientific Corp | 2020-05-05 |
| CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV) (P130021/S075) | Medtronic, Inc. | 2020-05-05 |
| Algovita Spinal Cord Stimulation System (P130028/S031) | Nuvectra Corporation | 2020-05-05 |
| cobas HPV (P190028/S001) | Roche Molecular Systems, Inc. | 2020-05-05 |
| Epic Vascular Self-Expanding Stent System (P110035/S056) | Boston Scientific Corp | 2020-05-05 |
| ReSure Sealant (P130004/S008) | Ocular Therapeutix, Inc. | 2020-05-05 |
| HeartWare Ventricular Assist System (P100047/S154) | Medtronic | 2020-05-05 |
| AcrySof (R) Intraocular Lenses (P930014/S130) | Alcon Laboratories, Inc. | 2020-05-05 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P170003/S018) | Lutonix | 2020-05-04 |
| 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/S739) | Medtronic Cardiac Rhythm Disease Management | 2020-05-04 |
| INGEVITY lead family (P150012/S094) | Boston Scientific | 2020-05-04 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad, Compia MRI, C (P010031/S700) | Medtronic Cardiac Rhythm Disease Management | 2020-05-04 |
| Adapta IPG, Versa IPG, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR M (P980035/S625) | Medtronic, Inc. | 2020-05-04 |
| TREO® Abdominal Stent-Graft System (P190015) | Bolton Medical, Inc. | 2020-05-04 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S435) | Medtronic, Inc. | 2020-05-04 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S036) | Lutonix | 2020-05-04 |
| Implantable Pulse Generator (IPG) (P130008/S047) | Inspire Medical Systems | 2020-05-03 |
| EnVeo R, EnVeo PRO, Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R, PRO and PRO+ Systems (P130021/S074) | Medtronic, Inc. | 2020-05-01 |
| TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of (P980040/S109) | Johnson & Johnson Surgical Vision, Inc. | 2020-05-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S077) | Syncardia Systems, LLC | 2020-05-01 |
| THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter, SF Bi-Directional Navigation (P030031/S105) | Biosense Webster, Inc. | 2020-04-30 |
| iStent inject Trabecular Micro-Bypass System (P170043/S007) | Glaukos Corporation | 2020-04-30 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System - RX and OTW (P110013/S102) | Medtronic Vascular | 2020-04-30 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW (P160043/S035) | Medtronic Vascular | 2020-04-30 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S009) | Heartsine Technologies, Ltd. | 2020-04-30 |
| THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter (P040036/S073) | Biosense Webster, Inc. | 2020-04-30 |
| iStent inject Trabecular Micro-Bypass System (P170043/S006) | Glaukos Corporation | 2020-04-30 |
| Nevisense (P150046/S004) | Scibase AB | 2020-04-30 |
| LCS Total Knee System (P830055/S244) | Depuy, Inc. | 2020-04-30 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S008) | Bard Peripheral Vascular, Inc. | 2020-04-30 |
| myChoice CDx (P190014/S001) | Myriad Genetic Laboratories, Inc. | 2020-04-29 |
| ARCHITECT Anti-HCV and Alinity i Anti-HCV (P050042/S043) | Abbott Laboratories, Inc. | 2020-04-29 |
| Arista AH Absorbable Hemostatic Particles (P050038/S035) | Davol, Inc. | 2020-04-29 |
| LCS Total Knee System (P830055/S246) | Depuy, Inc. | 2020-04-29 |
| SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S114) | Edwards Lifesciences, LLC | 2020-04-29 |
| Praxis Extended RAS Panel (P160038/S016) | Illumina, Inc. | 2020-04-28 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S006) | MicroVention, Inc. | 2020-04-28 |
| The Oxford Partial Knee System (P010014/S097) | Biomet Manufacturing Corp | 2020-04-27 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S025) | Gen-Probe Incorporated | 2020-04-27 |
| Aptima HPV Assay (P100042/S027) | Gen-Probe Incorporated | 2020-04-27 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S016) | Celonova Biosciences, Inc. | 2020-04-27 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S004) | Xvivo Perfusion, Inc. | 2020-04-26 |
| Biocor, Biocor Supra, Epic, and Epic Supra Valves (P040021/S043) | ABBOTT MEDICAL | 2020-04-25 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S028) | Nevro Corporation | 2020-04-25 |
| Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Cool Path Duo, MediGuide Enabled, and Safi (P110016/S067) | ABBOTT MEDICAL | 2020-04-24 |
| Xvivo Perfusion System (XPS) with Steen Solution Perfusate (P180014/S003) | Xvivo Perfusion, Inc. | 2020-04-24 |
| Therapy Dual-8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter and Safire TX Ablation Catheter (P040042/S045) | Irvine Biomedical,Inc.(Ibi) | 2020-04-24 |
| Therapy Cool Path Ablation Catheter (including all braid catheter) (P060019/S047) | Irvine Biomedical, Inc. | 2020-04-24 |
| Propel Family of Sinus Implants (P100044/S045) | Intersect Ent. | 2020-04-24 |
| BOND Oracle HER2 IHC System (P090015/S011) | Leica Biosystems | 2020-04-24 |