| Impella RP System (P170011/S020) | Abiomed, Inc. | 2020-01-24 |
| Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co (P030017/S331) | Boston Scientific Corp | 2020-01-24 |
| Astron Pulsar Stent System (P160025/S007) | Biotronik AG | 2020-01-23 |
| GORE TIGRIS Vascular Stent (P160004/S029) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S025) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S007) | Biotronik AG | 2020-01-23 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S005) | MicroVention, Inc. | 2020-01-23 |
| Hydrus Microstent (P170034/S004) | Alcon Research, LLC | 2020-01-23 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S001) | Biotronik AG | 2020-01-23 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S009) | Biotronik AG | 2020-01-23 |
| CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic) (P910066/S031) | Djo, LLC | 2020-01-23 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S074) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S135) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| MANTA Vascular Closure Device (P180025/S006) | Teleflex Medical, LLC | 2020-01-23 |
| MiniMed 630G Insulin Pump (P150001/S081) | Medtronic Minimed | 2020-01-22 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S076) | Syncardia Systems, LLC | 2020-01-22 |
| IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and (P140003/S066) | Abiomed, Inc. | 2020-01-22 |
| NeuroPace RNS System (P100026/S078) | NeuroPace, Inc. | 2020-01-22 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheter (P860004/S351) | Medtronic, Inc. | 2020-01-22 |
| MiniMed 670G Insulin Pump (P160017/S080) | Medtronic Minimed, Inc. | 2020-01-22 |
| Lotrafilcon A and B Soft contact lenses for extended wear (P010019/S075) | Alcon Laboratories, Inc. | 2020-01-22 |
| Implantable System for Remodulin (P140032/S048) | Medtronic, Inc. | 2020-01-22 |
| CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S022) | Ceramtec GmbH | 2020-01-22 |
| Akreos One-Piece Acrylic Intraocular Lens (IOL) (P060022/S025) | Bausch & Lomb, Inc. | 2020-01-21 |
| Aptima HPV Assay (P100042/S028) | Gen-Probe Incorporated | 2020-01-21 |
| Aptima HCV Quant Dx Assay (P160023/S016) | Hologic, Inc. | 2020-01-21 |
| Aptima HBV Quant Assay (P170025/S014) | Hologic, Inc. | 2020-01-21 |
| enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S041) | Bausch & Lomb, Inc. | 2020-01-21 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S026) | Gen-Probe Incorporated | 2020-01-21 |
| Neuroform Atlas® Stent System (P180031/S002) | Stryker Neurovascular | 2020-01-18 |
| Arctic Front Advance Pro Cryoballoon Catheter (P100010/S100) | Medtronic Cryocath, LP | 2020-01-17 |
| HiResolution Bionic Ear System (P960058/S147) | Advanced Bionics | 2020-01-17 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S013) | Physio-Control, Inc. | 2020-01-17 |
| Inspire Upper Airway Stimulation System (P130008/S049) | Inspire Medical Systems | 2020-01-16 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (THV) (P140031/S105) | Edwards Lifesciences, LLC | 2020-01-16 |
| enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S040) | Bausch & Lomb, Inc. | 2020-01-16 |
| Mara Water Vapor System (P160047/S006) | CooperSurgical, Inc. | 2020-01-16 |
| Synvisc/Synvisc-One (P940015/S045) | Sanofi Genzyme Corp. | 2020-01-16 |
| HeartLight System (P150026/S009) | Cardiofocus, Inc. | 2020-01-16 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S189) | Edwards Lifesciences, LLC | 2020-01-15 |
| EDWARDS INTUITY Elite Valve (P150036/S039) | Edwards Lifesciences, LLC | 2020-01-15 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S034) | Edwards Lifesciences, LLC | 2020-01-15 |
| Prometra II Programmable Infusion Pump System (P080012/S057) | Infusyn Therapeutics, LLC | 2020-01-15 |
| Micra Transcatheter Pacing System, Micra AV Application Software (P150033/S061) | Medtronic, Inc. | 2020-01-15 |
| Prometra Programmable Infusion Pump System (P080012/S064) | Infusyn Therapeutics, LLC | 2020-01-15 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S055) | St Jude Medical | 2020-01-14 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S001) | Boston Scientific Corporation | 2020-01-14 |
| VNS Therapy System (P970003/S229) | LivaNova USA, Inc. | 2020-01-13 |
| SelectSecure Lead (P030036/S116) | Medtronic Cardiac Rhythm Disease Management | 2020-01-10 |
| Implantable Pulse Generator, Sensing Lead, and Stimulation Lead (P130008/S048) | Inspire Medical Systems | 2020-01-10 |
| Patient-Fitted TMJ Reconstruction Prosthesis System (P980052/S007) | Stryker Leibinger, GmbH & Co KG | 2020-01-10 |
| Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG (P010032/S158) | ABBOTT MEDICAL | 2020-01-10 |
| Transvene CS/SVC Lead (P980050/S125) | Medtronic, Inc. | 2020-01-10 |
| Sprint Quattro, Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S240) | Medtronic, Inc. | 2020-01-10 |
| Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG. (P150004/S034) | ABBOTT MEDICAL | 2020-01-10 |
| Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG (P140009/S054) | ABBOTT MEDICAL | 2020-01-10 |
| Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint (P050031/S004) | CooperVision, Inc. | 2020-01-10 |
| Micra TPS (P150033/S064) | Medtronic, Inc. | 2020-01-09 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S201) | Medtronic Neuromodulation | 2020-01-09 |
| 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/S726) | Medtronic Cardiac Rhythm Disease Management | 2020-01-09 |
| REBEL Platinum Chromium Coronary Stent System Monorail (P130030/S065) | Boston Scientific Corp | 2020-01-09 |
| WOLVERINE Coronary Cutting Balloon Monorail (P950020/S100) | Boston Scientific Corp | 2020-01-09 |
| 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/S687) | Medtronic Cardiac Rhythm Disease Management | 2020-01-09 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S306) | Medtronic Neuromodulation | 2020-01-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S200) | Medtronic Neuromodulation | 2020-01-09 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S425) | Medtronic, Inc. | 2020-01-09 |
| Implantable System for Remodulin (P140032/S046) | Medtronic, Inc. | 2020-01-09 |
| Implantable System for Remodulin (P140032/S045) | Medtronic, Inc. | 2020-01-09 |
| Activa Deep Brain Stimulation Therapy System (P960009/S366) | Medtronic, Inc. | 2020-01-09 |
| AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System (P930014/S124) | Alcon Laboratories, Inc. | 2020-01-09 |
| 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, As (P980035/S612) | Medtronic, Inc. | 2020-01-09 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation systems, and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S452) | Medtronic Neuromodulation | 2020-01-09 |
| Drug Delivery Infusion Pumps SynchroMed (P860004/S349) | Medtronic, Inc. | 2020-01-09 |
| Activia Deep Brain Stimulation Therapy System (P960009/S367) | Medtronic, Inc. | 2020-01-09 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S008) | Heartsine Technologies, Ltd. | 2020-01-09 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S350) | Medtronic, Inc. | 2020-01-09 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S451) | Medtronic Neuromodulation | 2020-01-09 |
| Monovisc (P090031/S009) | Anika Therapeutics, Inc. | 2020-01-09 |
| Endurant, Endurant II and Endurant IIs Stent Graft System (P100021/S079) | Medtronic Vascular | 2020-01-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S305) | Medtronic Neuromodulation | 2020-01-09 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S086) | Dexcom, Inc. | 2020-01-08 |
| MARA Water Vapor System (P160047/S005) | CooperSurgical, Inc. | 2020-01-08 |
| Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory (P110029/S029) | Abbott Laboratories | 2020-01-07 |
| Consulta CRT-P, Syncra CRT-P and Viva CRT-P (P010015/S424) | Medtronic, Inc. | 2020-01-07 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI, Claria MRI Quad CRT-D, Compia MRI, C (P010031/S686) | Medtronic Cardiac Rhythm Disease Management | 2020-01-07 |
| Evera MRI DF-1 ICD, Evera MRI, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Protecta (P980016/S725) | Medtronic Cardiac Rhythm Disease Management | 2020-01-07 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG and Relia IPG (P980035/S611) | Medtronic, Inc. | 2020-01-07 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018) | Alcon Laboratories, LLC | 2020-01-07 |
| Current+, Fortify, Fortify Assura, Ellipse (P910023/S424) | ABBOTT MEDICAL | 2020-01-06 |
| Assurity MRI, Endurity MRI (P140033/S052) | ABBOTT MEDICAL | 2020-01-06 |
| Promote+, Unify, Unify Quandra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S375) | ABBOTT MEDICAL | 2020-01-06 |
| Endurity, Assurity, and Accent (P880086/S310) | ABBOTT MEDICAL | 2020-01-06 |
| Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP (P030035/S179) | ABBOTT MEDICAL | 2020-01-06 |
| Endurity, Endurity Core, and Assurity pacemakers (P880086/S311) | ABBOTT MEDICAL | 2020-01-06 |
| Endurity MRI, and Assurity MRI (P140033/S053) | ABBOTT MEDICAL | 2020-01-06 |
| Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S164) | Boston Scientific Corp | 2020-01-03 |
| LifeVest Wearable Defibrillator (P010030/S131) | Zoll Manufacturing Corporation | 2020-01-03 |
| PROMUS Element Plus, PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S163) | Boston Scientific Corp | 2020-01-03 |
| Euflexxa (1% Sodium Hyaluronate) (P010029/S029) | Ferring Pharmaceuticals, Inc. | 2020-01-02 |
| St. Jude Medical Infinity DBS Implantable Pulse Generator (P140009/S039) | ABBOTT MEDICAL | 2020-01-02 |