| Pulse Generator, Permanent Implantable DR-T/SR-T (P950037/S202) | Biotronik, Inc. | 2019-11-26 |
| Edwards Intuity Valves and Delivery Systems (P150036/S047) | Edwards Lifesciences, LLC | 2019-11-26 |
| InterStim Therapy System and Verify Evaluation System (P970004/S299) | Medtronic Neuromodulation | 2019-11-26 |
| Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath (P140031/S101) | Edwards Lifesciences, LLC | 2019-11-26 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S063) | Abiomed, Inc. | 2019-11-25 |
| 13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S006) | Advanced Breath Diagnostics | 2019-11-25 |
| Impella RP System (P170011/S019) | Abiomed, Inc. | 2019-11-25 |
| Tula® System (P190016) | Tusker Medical, Inc. | 2019-11-25 |
| LIFEPAK 20e defibrillator/monitor (P160026/S011) | Physio-Control, Inc. | 2019-11-25 |
| EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM (P160048/S012) | Senseonics, Incorporated | 2019-11-25 |
| Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial (P860057/S194) | Edwards Lifesciences, LLC | 2019-11-24 |
| Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve (P150048/S041) | Edwards Lifesciences, LLC | 2019-11-24 |
| Edwards Intuity Elite Valve System (P150036/S045) | Edwards Lifesciences, LLC | 2019-11-24 |
| Sapien XT Transcatheter Heart Valve (P130009/S104) | Edwards Lifesciences, LLC | 2019-11-24 |
| Sapien 3 Transcatheter Heart Valve and Ultra Transcatheter Heart Valve (P140031/S100) | Edwards Lifesciences, LLC | 2019-11-24 |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S008) | Rxsight, Inc. | 2019-11-22 |
| MiniMed 670G System (P150001/S074) | Medtronic Minimed | 2019-11-22 |
| SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno (P980040/S110) | Johnson & Johnson Surgical Vision, Inc. | 2019-11-22 |
| MiniMed 670G System (P160017/S072) | Medtronic Minimed, Inc. | 2019-11-22 |
| BD Onclarity HPV Assay (P160037/S003) | Becton, Dickinson and Company | 2019-11-22 |
| Guardian Connect System (P160007/S026) | Medtronic Minimed | 2019-11-22 |
| Paradigm Real-Time Revel System (P150019/S059) | Medtronic Minimed | 2019-11-22 |
| LifePulse High Frequency Ventilator (P850064/S041) | Bunnell, Inc. | 2019-11-22 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S022) | Nevro Corporation | 2019-11-22 |
| MiniMed 530G System (P120010/S134) | Medtronic, Inc. | 2019-11-22 |
| iPro2 CGM System with Enlite Sensor (P150029/S032) | Medtronic Minimed | 2019-11-22 |
| LOTUS Edge Valve System (P180029/S017) | Boston Scientific Corporation | 2019-11-21 |
| BioGlue Surgical Adhesive (P010003/S033) | Cryolife, Inc. | 2019-11-21 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S013) | Pulmonx Corporation | 2019-11-21 |
| Rotablator (Rotablator RotaLink Plus, RotaLink Burr)/ROTAPRO Rotational Atherectomy System (ROTAPRO Plus) (P900056/S180) | Boston Scientific Corp | 2019-11-21 |
| Sientra Opus Silicone Gel Breast Implants (P070004/S028) | Tiger Aesthetics Medical, LLC | 2019-11-21 |
| Micra Transcatheter Pacing System (P150033/S060) | Medtronic, Inc. | 2019-11-21 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S012) | Pulmonx Corporation | 2019-11-21 |
| Mitroflow Aortic Pericardial Heart Valve (P060038/S033) | Corcym Canada Corp | 2019-11-21 |
| LCS(R) Total Knee System (P830055/S235) | Depuy, Inc. | 2019-11-21 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008) | Medtronic Vascular, Inc. | 2019-11-21 |
| HeartMate 3 Left Ventricular Assist System (P160054/S022) | ABBOTT MEDICAL | 2019-11-20 |
| Micra MC1VR01 Transcatheter Pacing System (TPS) (P150033/S059) | Medtronic, Inc. | 2019-11-20 |
| HeartMate II Left Ventricular Assist System (P060040/S074) | ABBOTT MEDICAL | 2019-11-20 |
| Impella RP (P170011/S018) | Abiomed, Inc. | 2019-11-20 |
| EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst (P110023/S028) | Medtronic Vascular, Inc. | 2019-11-20 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S062) | Abiomed, Inc. | 2019-11-20 |
| Axium Neurostimulator System (P150004/S032) | ABBOTT MEDICAL | 2019-11-19 |
| Ventana PD-Ll (SP263) Assay (P160046/S006) | Ventana Medical Systems, Inc. | 2019-11-19 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S019) | Medinol, Ltd. | 2019-11-19 |
| Inform HER2 Dual ISH DNA Probe Cocktail (P100027/S031) | Ventana Medical Systems, Inc. | 2019-11-19 |
| SURGICEL Powder (N12159/S066) | ETHICON, Inc. | 2019-11-19 |
| LifeVest Wearable Defibrillator (P010030/S128) | Zoll Manufacturing Corporation | 2019-11-19 |
| HeartSines samaritan Public Access Automated External Defibrillators and Accessories (P160008/S007) | Heartsine Technologies, Ltd. | 2019-11-19 |
| Arista AH Absorbable Hemostat (P050038/S034) | Davol, Inc. | 2019-11-19 |
| Ventana PD-Ll (SP142) Assay (P160002/S010) | Ventana Medical Systems, Inc. | 2019-11-19 |
| Genesis Neurostimulation System (P010032/S155) | ABBOTT MEDICAL | 2019-11-19 |
| Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S041) | Ventana Medical Systems, Inc. | 2019-11-19 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S054) | Mentor Corp. | 2019-11-19 |
| MemoryShape Silicone Gel-Filled Breast Implants (P060028/S034) | Mentor Worldwide, LLC | 2019-11-19 |
| Saline-Filled and Spectrum Breast Implants (P990075/S046) | Mentor Worldwide, LLC | 2019-11-19 |
| Gore Cardioform ASD Occluder (P050006/S081) | W. L. Gore & Associates, Inc. | 2019-11-19 |
| Brio Neurostimulation System (P140009/S051) | ABBOTT MEDICAL | 2019-11-19 |
| Ventana ALK (D5F3) CDx Assay (P140025/S011) | Ventana Medical Systems, Inc. | 2019-11-19 |
| Edwards Intuity Elite Valve System (P150036/S044) | Edwards Lifesciences, LLC | 2019-11-18 |
| Edwards Inspiris Resilia Aortic Valve (P150048/S040) | Edwards Lifesciences, LLC | 2019-11-18 |
| Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial (P860057/S193) | Edwards Lifesciences, LLC | 2019-11-18 |
| MiniMed 670G System (P160017/S075) | Medtronic Minimed, Inc. | 2019-11-15 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S511) | Boston Scientific Corp | 2019-11-15 |
| iPro2 CGM System (P150029/S033) | Medtronic Minimed | 2019-11-15 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S444) | Boston Scientific | 2019-11-15 |
| MiniMed 530G System (P120010/S136) | Medtronic, Inc. | 2019-11-15 |
| Paradigm Real-Tme Revel System (P150019/S060) | Medtronic Minimed | 2019-11-15 |
| Guardian Connect System (P160007/S028) | Medtronic Minimed | 2019-11-15 |
| MiniMed 630G System (P150001/S077) | Medtronic Minimed | 2019-11-15 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035) | CooperVision, Inc. | 2019-11-15 |
| LCS Total Knee System (P830055/S237) | Depuy, Inc. | 2019-11-14 |
| Ellipse ICD Devices (P910023/S421) | ABBOTT MEDICAL | 2019-11-14 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S039) | The Cooper Companies | 2019-11-14 |
| methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S085) | CooperVision, Inc. | 2019-11-14 |
| Edwards Intuity Elite Delivery System (P150036/S046) | Edwards Lifesciences, LLC | 2019-11-14 |
| Oncomine Dx Target Test (P160045/S018) | Life Technologies Corporation | 2019-11-13 |
| LAP-BAND System (P000008/S047) | Medtimo, Inc. | 2019-11-13 |
| Mobi-C Cervical Disc Prosthesis (for Two-Level) (P110009/S022) | Highridge Medical, LLC | 2019-11-13 |
| AngioJet Rheolytic Thrombectomy System (P980037/S074) | Boston Scientific Corp | 2019-11-13 |
| Mobi-C Cervical Disc Prosthesis (one-level indications) (P110002/S022) | Highridge Medical, LLC | 2019-11-13 |
| Axonics Sacral Neuromodulation System (P180046) | Boston Scientific Corporation | 2019-11-13 |
| EnVeo Rand EnVeo PRO Delivery Catheter System of the CoreValve (P130021/S067) | Medtronic, Inc. | 2019-11-13 |
| Zephyr 5.5 EBV Circle Flange Valve (P180002/S010) | Pulmonx Corporation | 2019-11-13 |
| Lotus Edge Valve System (P180029/S016) | Boston Scientific Corporation | 2019-11-12 |
| CareLink SmartSync Device Manager and MyCareLink Patient Monitor (P890003/S420) | Medtronic, Inc. | 2019-11-12 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S002) | Biotronik AG | 2019-11-12 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S033) | Cook Ireland, Ltd. | 2019-11-12 |
| Abbott RealTime IDH1 Assay (P170041/S002) | Abbott Molecular, Inc. | 2019-11-12 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S027) | Nevro Corporation | 2019-11-08 |
| HeartLight Endoscopic Ablation System (P150026/S007) | Cardiofocus, Inc. | 2019-11-08 |
| Nucleus Auditory Brainstem Implant (P000015/S036) | Cochlear Americas | 2019-11-08 |
| Prometra Programmable Infusion Pump System (P080012/S061) | Infusyn Therapeutics, LLC | 2019-11-08 |
| Nucleus Cochlear Implant System (P970051/S185) | Cochlear Americas | 2019-11-08 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S022) | Medinol, Ltd. | 2019-11-07 |
| Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S179) | Boston Scientific Corp | 2019-11-07 |
| HEMOBLAST Bellows (P170012/S020) | Dilon Technologies, Inc. | 2019-11-07 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S013) | Celonova Biosciences, Inc. | 2019-11-07 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S122) | Boston Scientific | 2019-11-07 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S034) | Medinol, Ltd. | 2019-11-07 |