| Endurant II/IIs Stent Graft System (P100021/S082) | Medtronic Vascular | 2020-10-21 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S010) | Biotronik AG | 2020-10-21 |
| Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) and Orchestra Plus Link (P980049/S140) | MicroPort CRM USA, Inc. | 2020-10-20 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S032) | ABBOTT MEDICAL | 2020-10-20 |
| Mara Vapor System (P160047/S015) | CooperSurgical, Inc. | 2020-10-20 |
| Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator) (P060027/S104) | MicroPort CRM USA, Inc. | 2020-10-20 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S654) | Medtronic, Inc. | 2020-10-20 |
| Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers (P950029/S128) | MicroPort CRM USA, Inc. | 2020-10-20 |
| BOND Oracle HER2 IHC System (P090015/S012) | Leica Biosystems | 2020-10-20 |
| Mara Vapor System (P160047/S014) | CooperSurgical, Inc. | 2020-10-20 |
| Cologuard (P130017/S044) | Exact Sciences Corporation | 2020-10-20 |
| 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/S711) | Medtronic Cardiac Rhythm Disease Management | 2020-10-19 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S079) | Hologic, Inc. | 2020-10-19 |
| Elecsys HBsAg II Auto Confirm (P160019/S011) | Roche Diagnostics, Inc. | 2020-10-19 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S010) | Bausch and Lomb, Inc., | 2020-10-19 |
| Durata, Optisure (P950022/S135) | ABBOTT MEDICAL | 2020-10-16 |
| ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI Pacemakers (P150012/S100) | Boston Scientific | 2020-10-16 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S029) | Beckman Coulter, Inc. | 2020-10-16 |
| Therapy Cool Path SP Ablation Catheter (P060019/S049) | Irvine Biomedical, Inc. | 2020-10-16 |
| VALITUDE, VALITUDE X4, VISIONIST, and VISIONIST X4 CRT-P Devices (P030005/S201) | Guidant Corp. | 2020-10-16 |
| Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables (P960016/S085) | St Jude Medical | 2020-10-16 |
| C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric (P060011/S023) | Rayner Intraocular Lenses , Ltd. | 2020-10-16 |
| Therapy Ablation Catheter (P040014/S041) | Irvine Biomedical, Inc. | 2020-10-16 |
| EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator (P110042/S143) | Boston Scientific Corporation | 2020-10-16 |
| Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo Ablation Catheter, Safire Duo Ablation Catheter, MediGuide En (P110016/S071) | ABBOTT MEDICAL | 2020-10-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S055) | Beckman Coulter, Inc. | 2020-10-16 |
| Therapy Dual 8 and Therapy 8mm Tip Thermistor Ablation Catheter (P040042/S047) | Irvine Biomedical,Inc.(Ibi) | 2020-10-16 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S043) | Beckman Coulter, Inc. | 2020-10-16 |
| TREO Abdominal Stent-Graft System (P190015/S005) | Bolton Medical, Inc. | 2020-10-16 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S008) | Defibtech, LLC | 2020-10-16 |
| ORBERA Intragastric Balloon System (P140008/S021) | Boston Scientific Corporation | 2020-10-16 |
| Perceval Sutureless Heart Valve (P150011/S013) | Corcym S.r.l. | 2020-10-16 |
| TactiCath Quartz Contact Force Ablation Catheter, TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S065) | St Jude Medical | 2020-10-16 |
| ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE Pacemakers (N970003/S255) | Boston Scientific Corp | 2020-10-16 |
| Quickflex µ, Quartet (P030054/S384) | ABBOTT MEDICAL | 2020-10-16 |
| OraQuick HCV Rapid Antibody Test (P080027/S037) | OraSure Technologies, Inc. | 2020-10-16 |
| Access AFP Reagents on the Access Immunoassay System (P980041/S048) | Beckman Coulter, Inc. | 2020-10-16 |
| Isoflex (P960030/S070) | ABBOTT MEDICAL | 2020-10-16 |
| Biomedics Toric (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S047) | The Cooper Companies | 2020-10-16 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG (P980035/S648) | Medtronic, Inc. | 2020-10-15 |
| Endurant, Endurant II, and Endurant IIs Stent Graft System (P100021/S084) | Medtronic Vascular | 2020-10-15 |
| Gore TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S120) | W. L. Gore & Associates, Inc. | 2020-10-15 |
| FoundationOne CDx (P170019/S020) | Foundation Medicine, Inc. | 2020-10-15 |
| CapSure Sense Lead and Vitatron Crystalline Lead (P830061/S185) | Medtronic Cardiac Rhythm Disease Management | 2020-10-15 |
| Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs (P090022/S036) | Lenstec, Inc. | 2020-10-15 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S435) | Medtronic, Inc. | 2020-10-15 |
| RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S125) | Merz North America, Inc. | 2020-10-15 |
| SelectSecure Lead (P030036/S123) | Medtronic Cardiac Rhythm Disease Management | 2020-10-15 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S215) | Medtronic, Inc. | 2020-10-15 |
| Sprint Quattro Lead (P920015/S246) | Medtronic, Inc. | 2020-10-15 |
| RADIESSE Injectable Implant (P050037/S107) | Merz North America, Inc. | 2020-10-15 |
| CapSureFix MRI Lead (P090013/S309) | Medtronic, Inc. | 2020-10-15 |
| COAPTITE Injectable Implant (P040047/S061) | Merz North America, Inc. | 2020-10-15 |
| Inspire IV IPG (P130008/S062) | Inspire Medical Systems | 2020-10-14 |
| Restylane, Perlane, Restylane-L, Restylane Lyft with Lidocane and Restylane Silk Injectable Gels (P040024/S120) | Q-Med AB | 2020-10-14 |
| RADIESSE Injectable Implant, RADIESSE Hands and RADIESSE (+) Lidocaine Dermal Filler (P050052/S126) | Merz North America, Inc. | 2020-10-14 |
| TECNIS Toric 1-Piece Intraocular Lense (IOLs) (P980040/S115) | Johnson & Johnson Surgical Vision, Inc. | 2020-10-14 |
| IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S052) | Medtronic, Inc. | 2020-10-14 |
| COAPTITE Injectable Implant (P040047/S062) | Merz North America, Inc. | 2020-10-14 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S006) | Medtronic Vascular, Inc. | 2020-10-14 |
| Biocor, Biocor Supra, Epic, Epic Supra (P040021/S044) | ABBOTT MEDICAL | 2020-10-14 |
| RADIESSE Injectable Implant (P050037/S108) | Merz North America, Inc. | 2020-10-14 |
| Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S030) | Q-Med AB | 2020-10-14 |
| Trifecta and Trifecta Valve with Glide Technology (P100029/S043) | ABBOTT MEDICAL | 2020-10-14 |
| M6-C Artificial Cervical Disc (P170036/S007) | Spinal Kinetics, LLC | 2020-10-14 |
| Revanesse Versa+ (P160042/S012) | Prollenium Medical Technologies, Inc. | 2020-10-13 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S043) | Siemens Healthcare Diagnostics | 2020-10-13 |
| Adapta, Versa, Sensia IPG and Relia IPG (P980035/S645) | Medtronic, Inc. | 2020-10-13 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR (P980035/S646) | Medtronic, Inc. | 2020-10-13 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C (P110010/S182) | Boston Scientific Corp | 2020-10-13 |
| iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses (P080004/S037) | Hoya Surgical Optics, Inc. | 2020-10-13 |
| BD Onclarity HPV Assay (P160037/S009) | Becton, Dickinson and Company | 2020-10-13 |
| GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S140) | W. L. Gore & Associates, Inc. | 2020-10-13 |
| GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S079) | W. L. Gore & Associates, Inc. | 2020-10-13 |
| LifeVest Wearable Defibrillator (P010030/S141) | Zoll Manufacturing Corporation | 2020-10-13 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S065) | Boston Scientific Corporation | 2020-10-13 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S038) | Siemens Healthcare Diagnostics | 2020-10-13 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regenera (P900033/S090) | Integra Lifesciences Corp. | 2020-10-13 |
| Axonics Sacral Neuromodulation System (P180046/S020) | Boston Scientific Corporation | 2020-10-09 |
| Zilver Vena Venous Self-Expanding Stent (P200023) | Cook Ireland, Ltd. | 2020-10-09 |
| MetriQ Irrigation Tubing Set (P150005/S057) | Boston Scientific Corp | 2020-10-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT- (P010015/S451) | Medtronic, Inc. | 2020-10-09 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR (P980035/S644) | Medtronic, Inc. | 2020-10-09 |
| Solesta Injectable Gel (P100014/S026) | Palette Life Sciences | 2020-10-09 |
| Alto Abdominal Stent Graft System (P120006/S037) | Endologix, LLC | 2020-10-09 |
| MiniMed 630G System with SmartGuard (P150001/S088) | Medtronic Minimed | 2020-10-09 |
| Axonics Sacral Neuromodulation System (P190006/S020) | Boston Scientific Corporation | 2020-10-09 |
| MiniMed 670G System (P160017/S087) | Medtronic Minimed, Inc. | 2020-10-09 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG (P980035/S652) | Medtronic, Inc. | 2020-10-08 |
| GELSYN-3 (P110005/S006) | Ibsa Institut Biochimique SA | 2020-10-08 |
| M6-C Artificial Cervical Disc (P170036/S006) | Spinal Kinetics, LLC | 2020-10-08 |
| DUROLANE (P170007/S006) | Bioventus, LLC | 2020-10-08 |
| Medtronic Attesta and Sphera MRI SureScan IPG and Pacing System (P980035/S637) | Medtronic, Inc. | 2020-10-08 |
| GELSYN-3 (P110005/S005) | Ibsa Institut Biochimique SA | 2020-10-08 |
| Oncomine Dx Target Test (P160045/S022) | Life Technologies Corporation | 2020-10-08 |
| MedEl EAS System (P000025/S115) | Med-El Corp. | 2020-10-07 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S028) | Beckman Coulter, Inc. | 2020-10-07 |
| cobas HPV (P190028/S003) | Roche Molecular Systems, Inc. | 2020-10-07 |
| Adapta, Versa, Sensia IPG and Relia IPG (P980035/S647) | Medtronic, Inc. | 2020-10-07 |