| LifeVest® Wearable Defibrillator (P010030/S170) | Zoll Manufacturing Corporation | 2024-02-14 |
| MitraClip G4 System (P100009/S063) | ABBOTT MEDICAL | 2024-02-14 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC) (P150048/S078) | Edwards Lifesciences, LLC | 2024-02-13 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S043) | Medtronic Vascular, Inc. | 2024-02-13 |
| Abre Venous Self-expanding Stent System (P200026/S007) | Medtronic Vascular, Inc. | 2024-02-13 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S156) | Medtronic, Inc. | 2024-02-13 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S531) | Medtronic, Inc. | 2024-02-13 |
| Harmony Transcatheter Pulmonary Valve (P200046/S028) | Medtronic, Inc. | 2024-02-13 |
| Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (P170006/S032) | Medtronic, Inc. | 2024-02-13 |
| 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/S771) | Medtronic, Inc. | 2024-02-13 |
| Edwards INTUITY Elite Valve System (P150036/S073) | Edwards Lifesciences, LLC | 2024-02-13 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S216) | Edwards Lifesciences, LLC | 2024-02-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S183) | Medtronic, Inc. | 2024-02-13 |
| Melody Transcatheter Pulmonary Valve (P140017/S028) | Medtronic, Inc. | 2024-02-13 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System, (P160043/S077) | Medtronic Vascular | 2024-02-12 |
| LifeVest® Wearable Defibrillator (P010030/S175) | Zoll Manufacturing Corporation | 2024-02-10 |
| OPTIMIZER Smart Mini IPG (P180036/S025) | Impulse Dynamics (Usa), Inc. | 2024-02-09 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S007) | Cook Ireland, Ltd. | 2024-02-08 |
| Gore Viatorr TIPS (P040027/S095) | W. L. Gore & Associates, Inc. | 2024-02-07 |
| XACT Carotid Stent System (P040038/S043) | Abbott Vascular, Inc. | 2024-02-07 |
| Symplicity Spyral Renal Denervation System (P220026/S002) | Medtronic, Inc. | 2024-02-06 |
| GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S096) | W. L. Gore & Associates, Inc. | 2024-02-06 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S064) | Boston Scientific Corp | 2024-02-05 |
| ReCor Paradise® Ultrasound Renal Denervation System (P220023/S002) | Recor Medical, Inc. | 2024-02-05 |
| HeartMate 3 Left Ventricular Assist System (P160054/S064) | ABBOTT MEDICAL | 2024-02-02 |
| Vega Endocardial Pacing Leads (P130010/S001) | MicroPort CRM USA, Inc. | 2024-02-02 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013) | Edwards Lifesciences, LLC | 2024-02-01 |
| Nitron CryoConsole and Nitron Remote (P020045/S105) | Medtronic Cryocath, LP | 2024-02-01 |
| LifeVest® Wearable Defibrillator (P010030/S174) | Zoll Manufacturing Corporation | 2024-02-01 |
| HeartMate 3 Left Ventricular Assist System (P160054/S070) | ABBOTT MEDICAL | 2024-01-31 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S076) | Medtronic Vascular | 2024-01-31 |
| Endurant II Stent Graft System (P100021/S119) | Medtronic Vascular | 2024-01-31 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S098) | ABBOTT MEDICAL | 2024-01-31 |
| Valiant Thoracic Stent Graft with Captivia Delivery System (P100040/S061) | Medtronic Vascular | 2024-01-31 |
| In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter, In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter (P140010/S078) | Medtronic, Inc. | 2024-01-31 |
| CardioMEMS HF System (P100045/S072) | ABBOTT MEDICAL | 2024-01-31 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S077) | Medtronic, Inc. | 2024-01-31 |
| CoreValve EnVeo Pro Delivery Catheter System (P130021/S152) | Medtronic, Inc. | 2024-01-31 |
| Avalus Ultra Bioprosthesis (P170006/S025) | Medtronic, Inc. | 2024-01-31 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S530) | Medtronic, Inc. | 2024-01-30 |
| 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/S770) | Medtronic, Inc. | 2024-01-30 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030) | Farapulse, Inc. | 2024-01-30 |
| Evolut FX Delivery Catheter System (P130021/S154) | Medtronic, Inc. | 2024-01-29 |
| Guardian System (P150009/S011) | Avertix Medical, Inc. | 2024-01-25 |
| Avalus Bioprosthesis (P170006/S031) | Medtronic, Inc. | 2024-01-24 |
| Harmony Transcatheter Pulmonary Valve (P200046/S027) | Medtronic, Inc. | 2024-01-24 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S153) | Medtronic, Inc. | 2024-01-24 |
| MelodyTM Transcatheter Pulmonary Valve (P140017/S027) | Medtronic, Inc. | 2024-01-24 |
| Epic Plus and Epic Plus Supra (P040021/S056) | ABBOTT MEDICAL | 2024-01-23 |
| HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P (P160029/S022) | Philips Medical Systems, Inc. | 2024-01-23 |
| MitraClip G4 Clip Delivery System (P100009/S061) | ABBOTT MEDICAL | 2024-01-22 |
| Lead Repair Kit Model 6946 (P910073/S175) | Boston Scientific | 2024-01-19 |
| Medical Adhesive Model 6517 (P830060/S090) | Boston Scientific | 2024-01-19 |
| CardioMEMS HF System (P100045/S071) | ABBOTT MEDICAL | 2024-01-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co (P150003/S096) | Boston Scientific Corporation | 2024-01-19 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S055) | Boston Scientific Corp | 2024-01-19 |
| LifeVest® Wearable Defibrillator (P010030/S173) | Zoll Manufacturing Corporation | 2024-01-18 |
| XACT Carotid Stent System (P040038/S044) | Abbott Vascular, Inc. | 2024-01-17 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE Xpedition Everolimus Eluting Coronary Stent System, XIEN (P110019/S131) | Abbott Vascular | 2024-01-17 |
| Supera Peripheral Stent System (P120020/S031) | Abbott Vascular (Idef Technologies Inc) | 2024-01-17 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve (P150048/S077) | Edwards Lifesciences, LLC | 2024-01-16 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S769) | Medtronic, Inc. | 2024-01-12 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR IC (P980016/S878) | Medtronic Cardiac Rhythm Disease Management | 2024-01-12 |
| Aurora EV ICD (P220012/S011) | Medtronic, Inc. | 2024-01-12 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023) | W. L. Gore & Associates, Inc. | 2024-01-12 |
| 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 M (P010031/S844) | Medtronic Cardiac Rhythm Disease Management | 2024-01-12 |
| Thoraflex Hybrid (P210006/S007) | Vascutek, Ltd. | 2024-01-11 |
| HeartMate 3 Left Ventricular Assist System (P160054/S056) | ABBOTT MEDICAL | 2024-01-11 |
| BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Le (P180050/S012) | Cvrx, Inc. | 2024-01-11 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S182) | Medtronic, Inc. | 2024-01-10 |
| TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors (P200005) | Tz Medical, Inc. | 2024-01-09 |
| CentriMag Circulatory Support System (P170038/S012) | Abbott | 2024-01-09 |
| Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor (P100010/S144) | Medtronic Cryocath, LP | 2024-01-08 |
| Cardiva VASCADE Family (P120016/S035) | Cardiva Medical, Inc. | 2024-01-08 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter (P020045/S108) | Medtronic Cryocath, LP | 2024-01-08 |
| Avalus Bioprosthesis (P170006/S024) | Medtronic, Inc. | 2024-01-08 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S023) | Philips Medical Systems, Inc. | 2024-01-05 |
| Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S116) | Abiomed, Inc. | 2024-01-05 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S102) | W. L. Gore & Associates, Inc. | 2024-01-03 |
| Cardiva VASCADE Family (P120016/S034) | Cardiva Medical, Inc. | 2024-01-03 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S163) | W. L. Gore & Associates, Inc. | 2024-01-03 |
| OPTIMIZER® Smart System (P180036/S026) | Impulse Dynamics (Usa), Inc. | 2024-01-03 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S001) | Surmodics,Inc. | 2024-01-03 |
| Butylated Hydroxytoluene (BHT) (P010012/S579) | Boston Scientific Corp | 2024-01-03 |
| Occlutech® ASD Occluder and Occlutech® Pistol Pusher (P200032) | Occlutech Holding AG | 2023-12-29 |
| Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, Visionist X4 CRT-P (P030005/S235) | Guidant Corp. | 2023-12-29 |
| Essentio SR, Essento DR, Proponent Dr, Proponent El Dr, Accolade Sr, Accolade Dr, Accolade El Dr, Altrua 2 Sr, Altrua 2 (N970003/S290) | Boston Scientific Corp | 2023-12-29 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S060) | Medtronic Vascular | 2023-12-29 |
| Cardiva VASCADE Family (P120016/S031) | Cardiva Medical, Inc. | 2023-12-29 |
| Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent MRI SR, Proponent MRI DR, Accolade MRI SR, Accoldae MRI (P150012/S154) | Boston Scientific | 2023-12-29 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S071) | ABBOTT MEDICAL | 2023-12-28 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S099) | ABBOTT MEDICAL | 2023-12-28 |
| Cardiva VASCADE Family (P120016/S033) | Cardiva Medical, Inc. | 2023-12-28 |
| Accent, Accent MRI, Assurity, Assurity+, Endurity, Endurity Core (P880086/S331) | ABBOTT MEDICAL | 2023-12-27 |
| Microny (P970013/S093) | ABBOTT MEDICAL | 2023-12-27 |
| Endurity MRI, Assurity MRI (P140033/S082) | ABBOTT MEDICAL | 2023-12-27 |
| Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT (P030054/S415) | ABBOTT MEDICAL | 2023-12-27 |
| Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT (P910023/S460) | ABBOTT MEDICAL | 2023-12-27 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S197) | ABBOTT MEDICAL | 2023-12-27 |
| Duo Venous Stent System (P230021) | Philips Image Guided Therapy Corporation | 2023-12-26 |