| Micra AV TPS and Micra TPS (P150033/S085) | Medtronic, Inc. | 2020-11-02 |
| AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment (N970012/S183) | Boston Scientific Corp | 2020-10-30 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019) | Boston Scientific Corporation | 2020-10-30 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S016) | Pulmonx Corporation | 2020-10-30 |
| Talent Occluder (P100021/S085) | Medtronic Vascular | 2020-10-30 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S011) | Biotronik AG | 2020-10-30 |
| Integrity Rapid Exchange Coronary Stent System (P030009/S098) | Medtronic, Ireland | 2020-10-30 |
| TREO Abdominal Stent-Graft System (P190015/S006) | Bolton Medical, Inc. | 2020-10-30 |
| Mentor Saline-Filled and SPECTRUM Breast Implants (P990075/S048) | Mentor Worldwide, LLC | 2020-10-30 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S117) | Boston Scientific Corp | 2020-10-30 |
| EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, EnVeo PRO Lo (P130021/S081) | Medtronic, Inc. | 2020-10-30 |
| TREO Abdominal Stent-Graft System (P190015/S003) | Bolton Medical, Inc. | 2020-10-30 |
| AngioJet Rheolytic Thrombectomy Catheter (P980037/S082) | Boston Scientific Corp | 2020-10-29 |
| Prometra Programmable Infusion Pump System (P080012/S067) | Infusyn Therapeutics, LLC | 2020-10-29 |
| Assurity, Assurity+, and Endurity (P880086/S314) | ABBOTT MEDICAL | 2020-10-29 |
| Belotero Balance (P090016/S043) | Merz North America, Inc. | 2020-10-29 |
| Assurity MRI and Endurity MRI (P140033/S061) | ABBOTT MEDICAL | 2020-10-29 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S657) | Medtronic, Inc. | 2020-10-28 |
| Juvéderm Injectable Gel Implants (P110033/S056) | Allergan | 2020-10-28 |
| SynCardia temporary Total Artificial Heart System (P030011/S079) | Syncardia Systems, LLC | 2020-10-28 |
| Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System (P960009/S383) | Medtronic, Inc. | 2020-10-28 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S382) | ABBOTT MEDICAL | 2020-10-28 |
| Fortify, Fortify Assura, and Ellipse (P910023/S430) | ABBOTT MEDICAL | 2020-10-28 |
| Juvéderm Injectable Gel Implants (P050047/S078) | Allergan | 2020-10-28 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S010) | Bard Peripheral Vascular, Inc. | 2020-10-28 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv (P150048/S049) | Edwards Lifesciences, LLC | 2020-10-28 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S651) | Medtronic, Inc. | 2020-10-28 |
| MAXUM System (P010023/S014) | Ototronix, LLC | 2020-10-28 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S453) | Medtronic, Inc. | 2020-10-28 |
| SimplifEYE Preloaded Delivery System for enVista Intraocular Lens (P910056/S042) | Bausch & Lomb, Inc. | 2020-10-28 |
| Mentor Saline-Filled Breast Implants (P990075/S047) | Mentor Worldwide, LLC | 2020-10-27 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S078) | ABBOTT MEDICAL | 2020-10-27 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S018) | Berlin Heart, Inc. | 2020-10-27 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S109) | Edwards Lifesciences, LLC | 2020-10-27 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S055) | Mentor Corp. | 2020-10-27 |
| cobas EGFR Mutation Test v2 (P120019/S031) | Roche | 2020-10-27 |
| Mentor MemoryShape Breast Implants (P060028/S036) | Mentor Worldwide, LLC | 2020-10-27 |
| Perclose ProStyle Suture-Mediated Closue and Repair System (P960043/S107) | Abbott Vascular, Inc. | 2020-10-27 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S116) | Edwards Lifesciences, LLC | 2020-10-27 |
| ADVIA Centaur PSA Readypack Reagents (P950021/S023) | Siemens Healthcare Diagnostics | 2020-10-27 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S080) | Hologic, Inc. | 2020-10-27 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional) (P910023/S433) | ABBOTT MEDICAL | 2020-10-26 |
| TECNIS Multifocal Toric II Intraocular Lenses (P980040/S120) | Johnson & Johnson Surgical Vision, Inc. | 2020-10-26 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P200006) | Foundation Medicine, Inc. | 2020-10-26 |
| Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) (P960013/S115) | ABBOTT MEDICAL | 2020-10-26 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus (P180047/S001) | DiaSorin, Inc. | 2020-10-26 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S063) | ABBOTT MEDICAL | 2020-10-26 |
| Microny (P970013/S084) | ABBOTT MEDICAL | 2020-10-26 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL (P880086/S315) | ABBOTT MEDICAL | 2020-10-26 |
| 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/S650) | Medtronic, Inc. | 2020-10-26 |
| Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) (P950022/S136) | ABBOTT MEDICAL | 2020-10-26 |
| Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S386) | ABBOTT MEDICAL | 2020-10-26 |
| CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S216) | Medtronic, Inc. | 2020-10-26 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S182) | ABBOTT MEDICAL | 2020-10-26 |
| IsoFlex Optim (P960030/S071) | ABBOTT MEDICAL | 2020-10-26 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S009) | Defibtech, LLC | 2020-10-23 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S056) | Alcon Research, Ltd. | 2020-10-23 |
| GORE CARDIOFORM Septal Occluder (P050006/S085) | W. L. Gore & Associates, Inc. | 2020-10-23 |
| Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System (P120002/S018) | Cordis US Corporation | 2020-10-23 |
| FoundationOne CDx (F1CDx) (P170019/S017) | Foundation Medicine, Inc. | 2020-10-23 |
| Oncomine Dx Target Test (P160045/S021) | Life Technologies Corporation | 2020-10-23 |
| COAPTITE Injectable Implant (P040047/S063) | Merz North America, Inc. | 2020-10-23 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S017) | Berlin Heart, Inc. | 2020-10-23 |
| RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S127) | Merz North America, Inc. | 2020-10-23 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S043) | Cordis US Corporation | 2020-10-23 |
| VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI (P840064/S073) | Alcon Laboratories | 2020-10-23 |
| XVIVO Perfusion System with STEEN Solution Perfusate (P180014/S005) | Xvivo Perfusion, Inc. | 2020-10-23 |
| Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs (P090022/S037) | Lenstec, Inc. | 2020-10-23 |
| RADIESSE Injectable Implant (P050037/S109) | Merz North America, Inc. | 2020-10-23 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA - ICD Device (P960040/S453) | Boston Scientific | 2020-10-22 |
| HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories (P160008/S014) | Heartsine Technologies, Ltd. | 2020-10-22 |
| EMBLEM S-ICD - Subcutaneous Devices (P110042/S142) | Boston Scientific Corporation | 2020-10-22 |
| 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, Cobalt (P010031/S717) | Medtronic Cardiac Rhythm Disease Management | 2020-10-22 |
| Bulkamid Urethral Bulking System (P170023/S003) | Boston Scientific Corporation | 2020-10-22 |
| PG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG (N970003/S257) | Boston Scientific Corp | 2020-10-22 |
| Avalus Bioprosthesis (P170006/S018) | Medtronic, Inc. | 2020-10-22 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S452) | Medtronic, Inc. | 2020-10-22 |
| XIENCE Sierra Stent System (P110019/S112) | Abbott Vascular | 2020-10-22 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S756) | Medtronic Cardiac Rhythm Disease Management | 2020-10-22 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036) | Ortho-Clinical Diagnostics, Inc. | 2020-10-22 |
| LIFEPAK CR2 Defibrillator (P170018/S011) | Physio-Control, Inc. | 2020-10-22 |
| PG VALITUDE CRT-P and PG VISIONIST CRT-P (P030005/S203) | Guidant Corp. | 2020-10-22 |
| INVIVE, INTUA, VISIONIST, VALITUDE - CRT-P Resynchronization Devices (P030005/S200) | Guidant Corp. | 2020-10-22 |
| Micra AV TPS and Micra AV TPS (P150033/S086) | Medtronic, Inc. | 2020-10-22 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIOMRI, PROPONENT MRI, ACCOLADE MRI - Pacemaker Devices (P150012/S099) | Boston Scientific | 2020-10-22 |
| 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/S649) | Medtronic, Inc. | 2020-10-22 |
| ICD AUTOGEN CRT-D, ICD DYNAGEN CRT-D, ICD INOGEN CRT-D, ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, RESONATE CR (P010012/S524) | Boston Scientific Corp | 2020-10-22 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult (N970003/S254) | Boston Scientific Corp | 2020-10-22 |
| PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M (P150012/S102) | Boston Scientific | 2020-10-22 |
| Plasmaflo OP-05W(A) (P820033/S013) | Asahi Kasei Medical Co., Ltd. | 2020-10-22 |
| ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN (P960040/S455) | Boston Scientific | 2020-10-22 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT - CRT-D Resynchroniza (P010012/S522) | Boston Scientific Corp | 2020-10-22 |
| LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator, LATITUDE NXT Syst (P910077/S180) | Boston Scientific | 2020-10-22 |
| Abre Venous Self-expanding Stent System (P200026) | Medtronic Vascular, Inc. | 2020-10-21 |
| LCS Total Knee System (P830055/S257) | Depuy, Inc. | 2020-10-21 |
| DUROLANE (P170007/S008) | Bioventus, LLC | 2020-10-21 |
| Adapta, Versa, Sensia IPG (P980035/S656) | Medtronic, Inc. | 2020-10-21 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S077) | Medtronic Vascular | 2020-10-21 |
| Implantable System for Remodulin (P140032/S047) | Medtronic, Inc. | 2020-10-21 |
| MED-EL Cochlear Implant System (P000025/S119) | Med-El Corp. | 2020-10-21 |