| Venovo Venous Stent System (P180037/S003) | Bard Peripheral Vascular, Inc. | 2020-09-25 |
| EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter (P990025/S060) | Biosense Webster, Inc. | 2020-09-24 |
| Inspire Upper Airway Stimulation (P130008/S059) | Inspire Medical Systems | 2020-09-24 |
| EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, EZ Steer Thermocool Bi-Directional Electrophysiology (P030031/S108) | Biosense Webster, Inc. | 2020-09-24 |
| EZ Steer NAV DS Bi-Directional Electrophysiology Catheter (P010068/S060) | Biosense Webster, Inc. | 2020-09-24 |
| EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter (P950005/S075) | Biosense Webster, Inc. | 2020-09-24 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S067) | Zimmer, Inc. | 2020-09-24 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S009) | Bard Peripheral Vascular, Inc. | 2020-09-24 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S004) | Medtronic Vascular, Inc. | 2020-09-24 |
| SURGICEL FIBRILLAR Absorbable Hemostat (N12159/S073) | ETHICON, Inc. | 2020-09-24 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S005) | Fujirebio Europe N.V. | 2020-09-23 |
| One-Piece IOLs with Daisy-Wheel packaging configuration, One-Piece IOLs with TENIC iTEC Preloaded Delivery System, One-P (P980040/S121) | Johnson & Johnson Surgical Vision, Inc. | 2020-09-23 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S449) | Medtronic, Inc. | 2020-09-23 |
| Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and (P910023/S432) | ABBOTT MEDICAL | 2020-09-23 |
| Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D (P030054/S385) | ABBOTT MEDICAL | 2020-09-23 |
| 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/S640) | Medtronic, Inc. | 2020-09-23 |
| Excor Pediatric Ventricular Assist Device (P160035/S013) | Berlin Heart, Inc. | 2020-09-23 |
| TECNIS iTEC Preloaded Delivery System, TECNIS Simplicity Delivery System (P980040/S122) | Johnson & Johnson Surgical Vision, Inc. | 2020-09-23 |
| INCRAFT(R) AAA STENT GRAFT SYSTEM (P150002/S008) | Cordis US Corporation | 2020-09-23 |
| WOLVERINE Coronary Cutting Balloon (P950020/S109) | Boston Scientific Corp | 2020-09-22 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S360) | Medtronic, Inc. | 2020-09-22 |
| Implantable System for Remodulin (P140032/S057) | Medtronic, Inc. | 2020-09-22 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S034) | Medtronic Vascular | 2020-09-22 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S341) | Boston Scientific Corp | 2020-09-22 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/ II+ (P030054/S380) | ABBOTT MEDICAL | 2020-09-22 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S151) | Medtronic, Inc. | 2020-09-22 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne (P910023/S428) | ABBOTT MEDICAL | 2020-09-22 |
| Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses Extended Wear (P890023/S045) | The Cooper Companies | 2020-09-22 |
| Axonics Sacral Neuromodulation System (P190006/S021) | Boston Scientific Corporation | 2020-09-21 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S116) | CooperVision, Inc. | 2020-09-21 |
| Axonics Sacral Neuromodulation System (P180046/S021) | Boston Scientific Corporation | 2020-09-21 |
| Revanesse® Lips+ (P160042/S010) | Prollenium Medical Technologies, Inc. | 2020-09-21 |
| AngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S028) | Spectranetics Corp. | 2020-09-21 |
| SURGICEL Powder Absorbable Hemostatic Powder (N12159/S069) | ETHICON, Inc. | 2020-09-21 |
| Pipeline Flex Embolization Device (P100018/S028) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-21 |
| VenaSeal Closure System (P140018/S020) | Medtronic Vascular, Inc. | 2020-09-21 |
| 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/S754) | Medtronic Cardiac Rhythm Disease Management | 2020-09-18 |
| 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/S639) | Medtronic, Inc. | 2020-09-18 |
| MANTA Vascular Closure Device (P180025/S008) | Teleflex Medical, LLC | 2020-09-18 |
| 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/S715) | Medtronic Cardiac Rhythm Disease Management | 2020-09-18 |
| Simplify® Cervical Artificial Disc (P200022) | Nuvasive, Inc. | 2020-09-18 |
| LifeVest Wearable Defibrillator (P010030/S142) | Zoll Manufacturing Corporation | 2020-09-17 |
| AMS 800 Artificial Urinary Sphincter (AUS) with InhibiZone Treatment (P000053/S116) | Boston Scientific Corp | 2020-09-17 |
| Carbomedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis, Carbo-Seal Valsalva Ascending Aortic Prosthe (P900060/S061) | Corcym S.r.l. | 2020-09-17 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S180) | Boston Scientific Corp | 2020-09-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S063) | Boston Scientific Corporation | 2020-09-17 |
| LATITUDE Programming System (Programmer) (P910077/S181) | Boston Scientific | 2020-09-17 |
| Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S149) | Biotronik, Inc. | 2020-09-17 |
| LOTUS Edge Valve System (P180029/S026) | Boston Scientific Corporation | 2020-09-17 |
| EMBLEM S-ICD Programmer (P110042/S144) | Boston Scientific Corporation | 2020-09-17 |
| AED 3 BLS (P160022/S021) | ZOLL Medical Corporation | 2020-09-17 |
| Superion Indirect Decompression System (P140004/S022) | Boston Scientific Neuromodulation | 2020-09-17 |
| LIFEPAK CR2 Automated External Defibrillator (P170018/S008) | Physio-Control, Inc. | 2020-09-17 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment (N970012/S182) | Boston Scientific Corp | 2020-09-16 |
| VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System (P840064/S072) | Alcon Laboratories | 2020-09-16 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S115) | CooperVision, Inc. | 2020-09-16 |
| Inspire Implantable Pulse Generator (P130008/S058) | Inspire Medical Systems | 2020-09-16 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S055) | Alcon Research, Ltd. | 2020-09-16 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S176) | W. L. Gore & Associates, Inc. | 2020-09-16 |
| DuraSeal Exact Spine Sealant System (P080013/S021) | Integra LifeSciences Corporation | 2020-09-16 |
| Superion Indirect Decompression System (P140004/S020) | Boston Scientific Neuromodulation | 2020-09-16 |
| Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S044) | The Cooper Companies | 2020-09-16 |
| DuraSeal Dural Sealant System (P040034/S032) | Integra LifeSciences Corporation | 2020-09-16 |
| LIFEPAK Automated External Defibrillators (P160026/S020) | Physio-Control, Inc. | 2020-09-16 |
| Cobalt MRI CRT-P, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S714) | Medtronic Cardiac Rhythm Disease Management | 2020-09-15 |
| Superion Indirect Decompression System (P140004/S024) | Boston Scientific Neuromodulation | 2020-09-15 |
| Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD (P910023/S429) | ABBOTT MEDICAL | 2020-09-15 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S448) | Medtronic, Inc. | 2020-09-15 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S753) | Medtronic Cardiac Rhythm Disease Management | 2020-09-15 |
| Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D (P030054/S381) | ABBOTT MEDICAL | 2020-09-15 |
| VICI VENOUS STENT System (P180013/S002) | Boston Scientific Corporation | 2020-09-15 |
| Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console (P160047/S013) | CooperSurgical, Inc. | 2020-09-14 |
| Surpass Streamline Flow Diverter (P170024/S004) | Stryker Neurovascular | 2020-09-14 |
| Percept Deep Brain Stimulation Therapy System (P960009/S381) | Medtronic, Inc. | 2020-09-11 |
| Omnilink Elite OTW Stent System (P110043/S012) | Abbott Vascular-Cardiac Therapies | 2020-09-11 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S005) | Medtronic Vascular, Inc. | 2020-09-11 |
| AngioSculpt PTCA Scoring Balloon Catheter, Rapid Exchange (RX) (P050018/S026) | Spectranetics Corp. | 2020-09-11 |
| Multi-Link Vision RX Coronary Stent System, Multi-Link Mini Vision RX Coronary Stent System, Multi-Link 8/8SV/8LL Corona (P020047/S073) | Abbott Vascular | 2020-09-11 |
| HEMOBLAST Bellows (P170012/S023) | Dilon Technologies, Inc. | 2020-09-11 |
| Subcutaneous Implantable Cardioverter Defibrillator (P110042/S145) | Boston Scientific Corporation | 2020-09-10 |
| Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus) and ROTAPRO Rotational Atherectomy System (ROTAPRO, (P900056/S187) | Boston Scientific Corp | 2020-09-10 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S362) | Medtronic, Inc. | 2020-09-09 |
| AMS 700 Inflatable Penile Prosthesis with and without Inhibizone Treatment (N970012/S181) | Boston Scientific Corp | 2020-09-09 |
| Superion Indirect Decompression System (P140004/S023) | Boston Scientific Neuromodulation | 2020-09-09 |
| Activa Deep Brain Stimulation Therapy System (P960009/S380) | Medtronic, Inc. | 2020-09-09 |
| Superion Indirect Decompression System (P140004/S021) | Boston Scientific Neuromodulation | 2020-09-09 |
| Floseal Hemostatic Matrix (P990009/S062) | Baxter Healthcare Corp | 2020-09-09 |
| EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S112) | Edwards Lifesciences, LLC | 2020-09-09 |
| Implantable System for Remodulin (P140032/S060) | Medtronic, Inc. | 2020-09-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S209) | Medtronic Neuromodulation | 2020-09-09 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist. (P140003/S075) | Abiomed, Inc. | 2020-09-09 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S467) | Medtronic Neuromodulation | 2020-09-09 |
| Venovo Venous Stent System (P180037/S002) | Bard Peripheral Vascular, Inc. | 2020-09-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S314) | Medtronic Neuromodulation | 2020-09-09 |
| IMMULITE 2000 HBsAg Confirmatory (P010050/S018) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| IMMULITE 2000 Anti-HBcM (P010053/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| LCS Total Knee System (P830055/S255) | Depuy, Inc. | 2020-09-08 |
| IMMULITE 2000 Anti-HBs (P010052/S014) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA (P930027/S024) | Siemens Healthcare Diagnostics, Inc. | 2020-09-08 |
| IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP (P010007/S013) | Siemens Healthcare Diagnostics, Inc. | 2020-09-08 |