| Edwards Commander Delivery System (P140031/S153) | Edwards Lifesciences, LLC | 2023-03-22 |
| VISTAKON (Senofilcon A) Brand Contact Lenses (P040045/S130) | Vistakon, Division of Johnson & Johnson Vision Car | 2023-03-22 |
| HiResolution Bionic Ear System (P960058/S157) | Advanced Bionics | 2023-03-22 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S023) | Biotronik AG | 2023-03-22 |
| Edwards Commander Delivery System (P200015/S035) | Edwards Lifesciences, LLC | 2023-03-22 |
| Micra AV TPS, Micra TPS (P150033/S153) | Medtronic, Inc. | 2023-03-22 |
| iCast Covered Stent System (P120003) | Atrium Medical Corp. | 2023-03-22 |
| Revanesse Versa, Revanesse Versa+ with Lidocaine, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.2 mL, Revane (P160042/S020) | Prollenium Medical Technologies, Inc. | 2023-03-22 |
| Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters (P200039/S010) | Shockwave Medical, Inc. | 2023-03-22 |
| Epic Vascular Self-Expanding Stent System (P110035/S069) | Boston Scientific Corp | 2023-03-21 |
| Medtronic Evolut PRO+ System and Medtronic Evolut FX System (P130021/S132) | Medtronic, Inc. | 2023-03-21 |
| HeartMate II Left Ventricular Assist System (P060040/S090) | ABBOTT MEDICAL | 2023-03-21 |
| OPTIMIZER Smart Mini System (P180036/S016) | Impulse Dynamics (Usa), Inc. | 2023-03-21 |
| Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S020) | The Spectranetics Corp. | 2023-03-21 |
| Eluvia Drug Eluting Vascular Stent System (P180011/S054) | Boston Scientific Corp | 2023-03-21 |
| Innova Self-Expanding Stent System (P140028/S077) | Boston Scientific Corporation | 2023-03-21 |
| ELCA Coronary Atherectomy Catheters (P910001/S118) | Spectranetics Corp. | 2023-03-21 |
| Inspire Upper Airway Stimulation (P130008/S089) | Inspire Medical Systems | 2023-03-20 |
| T-SPOT.TB Test (P070006/S018) | Oxford Immunotec, Ltd. | 2023-03-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S043) | Medinol, Ltd. | 2023-03-20 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S113) | Medtronic Vascular | 2023-03-17 |
| Attain Stability Quad MRI Surescan (P080006/S175) | Medtronic, Inc. | 2023-03-17 |
| Spinal Cord Stimulator (SCS) Accessories (P840001/S537) | Medtronic Neuromodulation | 2023-03-17 |
| Valiant Thoracic Stent Graft with Captivia Delivery System (P100040/S056) | Medtronic Vascular | 2023-03-17 |
| Deep Brain Stimulation (DBS) Accessories (P960009/S447) | Medtronic, Inc. | 2023-03-17 |
| Pipeline Flex with Shield Technology (P100018/S039) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2023-03-16 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S158) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S008) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S157) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S041) | Cook Ireland, Ltd. | 2023-03-16 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S096) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S538) | Medtronic Neuromodulation | 2023-03-16 |
| Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, Juvéderm Ultra Plus XC (P050047/S083) | Allergan | 2023-03-16 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S037) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| Zilver® Vascular Stent (P050017/S021) | Cook Ireland, Ltd. | 2023-03-16 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvederm Volbella XC (P110033/S063) | Allergan | 2023-03-16 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S448) | Medtronic, Inc. | 2023-03-16 |
| Cologuard® (P130017/S055) | Exact Sciences Corporation | 2023-03-16 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S004) | Cook Ireland, Ltd. | 2023-03-16 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S097) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| Simplify Cervical Artificial Disc (P200022/S010) | Nuvasive, Inc. | 2023-03-15 |
| PROMUS ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S208) | Boston Scientific Corp | 2023-03-15 |
| SYNERGY and SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S091) | Boston Scientific Corporation | 2023-03-15 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S353) | Medtronic Neuromodulation | 2023-03-14 |
| SynchroMed® Infusion System (P860004/S385) | Medtronic, Inc. | 2023-03-14 |
| Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S418) | Medtronic, Inc. | 2023-03-14 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S248) | Medtronic Neuromodulation | 2023-03-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S849) | Medtronic Cardiac Rhythm Disease Management | 2023-03-14 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S815) | Medtronic Cardiac Rhythm Disease Management | 2023-03-14 |
| Hydrus® Microstent (P170034/S008) | Alcon Research, LLC | 2023-03-14 |
| Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems (P840001/S509) | Medtronic Neuromodulation | 2023-03-14 |
| Telemetry Wand (P110042/S179) | Boston Scientific Corporation | 2023-03-14 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S011) | W. L. Gore and Associates, Inc. | 2023-03-14 |
| Medtronic MiniMed 630G System (MM630G) (P150001/S105) | Medtronic Minimed | 2023-03-13 |
| Medtronic MiniMed 670G System (MM670G), Medtronic MiniMed 770G System (MM770G) (P160017/S109) | Medtronic Minimed, Inc. | 2023-03-13 |
| DiamondTemp Ablation System (P200028/S016) | Medtronic, Inc. | 2023-03-13 |
| Mara Water Vapor Ablation System; Mara Water Vapor System; Mara Console (P160047/S029) | CooperSurgical, Inc. | 2023-03-13 |
| eCoin implanted tibial stimulator (P200036/S005) | Boston Scientific Corporation | 2023-03-13 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK (P860003/S109) | Therakos Development Limited | 2023-03-13 |
| Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro (P810031/S074) | Johnson & Johnson Surgical Vision, Inc. | 2023-03-13 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P150003/S092) | Boston Scientific Corporation | 2023-03-10 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S135) | Boston Scientific Corp | 2023-03-10 |
| GELSYN-3 (P110005/S013) | Ibsa Institut Biochimique SA | 2023-03-10 |
| Promus Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S209) | Boston Scientific Corp | 2023-03-10 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S449) | Medtronic, Inc. | 2023-03-10 |
| Thermocool Smarttouch Bi-directional Catheter, Thermocool Smarttouch Bi-directional Catheter (P040036/S093) | Biosense Webster, Inc. | 2023-03-10 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S037) | Boston Scientific Corp | 2023-03-10 |
| Thermocool Smarttouch SF Uni-directional Catheter, Thermocool Smarttouch SF Uni-directional Catheter (P030031/S131) | Biosense Webster, Inc. | 2023-03-10 |
| Edwards Commander Delivery System (P140031/S143) | Edwards Lifesciences, LLC | 2023-03-09 |
| CapSureFix MRI Lead (P090013/S326) | Medtronic, Inc. | 2023-03-09 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S742) | Medtronic, Inc. | 2023-03-09 |
| CapSureFix Novus Lead (P930039/S249) | Medtronic, Inc. | 2023-03-09 |
| TherOx Downstream System (P170027/S008) | Zoll Circulation, Inc. | 2023-03-09 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S023) | Alcon Laboratories, LLC | 2023-03-09 |
| Edwards Commander Delivery System (P200015/S026) | Edwards Lifesciences, LLC | 2023-03-09 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S145) | Biotronik, Inc. | 2023-03-09 |
| Pulse Generator, Permanent, Implantable (P950037/S245) | Biotronik, Inc. | 2023-03-09 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S405) | Medtronic, Inc. | 2023-03-09 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S136) | Boston Scientific Corp | 2023-03-09 |
| HeartWare Ventricular Assist System (P100047/S206) | Medtronic | 2023-03-08 |
| Express SD Renal Monorail Premounted Stent System (P060006/S106) | Boston Scientific Corp | 2023-03-08 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P200006/S004) | Foundation Medicine, Inc. | 2023-03-08 |
| FoundationOne Liquid CDx (P200016/S002) | Foundation Medicine, Inc. | 2023-03-08 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S152) | Edwards Lifesciences, LLC | 2023-03-08 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S009) | Foundation Medicine, Inc. | 2023-03-08 |
| Express LD Iliac Premounted Stent System (P090003/S055) | Boston Scientific Corporation | 2023-03-08 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S134) | W. L. Gore & Associates, Inc. | 2023-03-08 |
| Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S094) | Inspire Medical Systems | 2023-03-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S843) | Medtronic Cardiac Rhythm Disease Management | 2023-03-07 |
| RelayPro Thoracic Stent-Graft System (P200045/S002) | Bolton Medical, Inc. | 2023-03-07 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S048) | ABBOTT MEDICAL | 2023-03-07 |
| CALCIVIS Imaging System (P170029) | Calcivis Limited | 2023-03-07 |
| TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs, TECNIS Eyhance IOL, TECNIS Eyhan (P980040/S157) | Johnson & Johnson Surgical Vision, Inc. | 2023-03-06 |
| Arctic Front Advance (P100010/S137) | Medtronic Cryocath, LP | 2023-03-06 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Siroiimus Eiuting Coronary Stent System (P170030/S027) | Biotronik AG | 2023-03-03 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S034) | Edwards Lifesciences, LLC | 2023-03-03 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S006) | Edwards Lifesciences, LLC | 2023-03-03 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S016) | Biotronik AG | 2023-03-03 |
| Pioneer 2.0 HVAD Controller (P100047/S208) | Medtronic | 2023-03-03 |
| CentriMag Circulatory Support System (P170038/S011) | Abbott | 2023-03-03 |