| RelayPro Thoracic Stent-Graft System (P200045/S012) | Bolton Medical, Inc. | 2024-07-18 |
| Latitude NXT Patient Management System (ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, AL (N970003/S293) | Boston Scientific Corp | 2024-07-18 |
| TREO Abdominal Stent-Graft System (P190015/S020) | Bolton Medical, Inc. | 2024-07-18 |
| LifeVest Wearable Defibrillator, Model 5100 (P010030/S184) | Zoll Manufacturing Corporation | 2024-07-18 |
| Latitude NXT Patient Management System (P910077/S194) | Boston Scientific | 2024-07-18 |
| Latitude NXT Patient Management System (INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S157) | Boston Scientific | 2024-07-18 |
| Latitude NXT Patient Management System (INVIVE, INTUA, VISIONIST, VALITUDE) (P030005/S238) | Guidant Corp. | 2024-07-18 |
| Latitude NXT Patient Management System (TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, (P960040/S500) | Boston Scientific | 2024-07-18 |
| Latitude NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, (P010012/S582) | Boston Scientific Corp | 2024-07-18 |
| Latitude NXT Patient Management System (EMBLEM S-ICD) (P110042/S195) | Boston Scientific Corporation | 2024-07-18 |
| 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/S784) | Medtronic, Inc. | 2024-07-17 |
| INTELLAGEN Cardiac Ablation System (P920047/S133) | Boston Scientific Corp | 2024-07-17 |
| INTELLAGEN Cardiac Ablation System (P020025/S141) | Boston Scientific | 2024-07-17 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S542) | Medtronic, Inc. | 2024-07-17 |
| INTELLAGEN Cardiac Ablation System (P150005/S079) | Boston Scientific Corp | 2024-07-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S081) | ABBOTT MEDICAL | 2024-07-16 |
| HeartMate II Left Ventricular Assist System (P060040/S105) | ABBOTT MEDICAL | 2024-07-16 |
| MitraClip G4 Clip Delivery System (P100009/S066) | ABBOTT MEDICAL | 2024-07-16 |
| Symplicity G3 Renal RF Generator (P220026/S005) | Medtronic, Inc. | 2024-07-16 |
| Synergy Everolimus-eluting Platinum Chromium Coronary Stent System (P150003/S099) | Boston Scientific Corporation | 2024-07-16 |
| QDOT MICRO Uni-Directional Navigation Catheter (P210027/S011) | Biosense Webster, Inc. | 2024-07-16 |
| LifeVest Wearable Defibrillator (P010030/S183) | Zoll Manufacturing Corporation | 2024-07-15 |
| XACT Transcarotid Stent System (XACT TSS) (P040038/S045) | Abbott Vascular, Inc. | 2024-07-15 |
| CentriMag Circulatory Support System (P170038/S019) | Abbott | 2024-07-15 |
| Aveir VR Leadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker (Right Ventricular) (P150035/S012) | ABBOTT MEDICAL | 2024-07-12 |
| IntellaNav StablePoint Catheter and Open-Irrigated Catheter (P150005/S085) | Boston Scientific Corp | 2024-07-12 |
| LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft (P220025/S002) | LimFlow, Inc. | 2024-07-11 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P980016/S896) | Medtronic Cardiac Rhythm Disease Management | 2024-07-11 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S862) | Medtronic Cardiac Rhythm Disease Management | 2024-07-11 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S049) | Medtronic Vascular, Inc. | 2024-07-10 |
| Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System (P060001/S043) | Medtronic Vascular, Inc. | 2024-07-10 |
| Abre Venous Self-expanding Stent System (P200026/S010) | Medtronic Vascular, Inc. | 2024-07-10 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S012) | Cook Medical Incorporated | 2024-07-09 |
| Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor (P900060/S067) | Corcym S.r.l. | 2024-07-09 |
| Zenith Dissection Endovascular System (P180001/S013) | William Cook Europe Aps | 2024-07-09 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S006) | Boston Scientific Corporation | 2024-07-05 |
| Sprint Quattro Lead (P920015/S290) | Medtronic, Inc. | 2024-07-05 |
| FARAPULSE Pulsed Field Ablation System (P230030/S005) | Farapulse, Inc. | 2024-07-05 |
| Conformable GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S138) | W. L. Gore & Associates, Inc. | 2024-07-03 |
| HeartWare HVAD System (P100047/S217) | Medtronic | 2024-07-03 |
| Arctic Front Advance Pro (P100010/S148) | Medtronic Cryocath, LP | 2024-07-03 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S044) | Berlin Heart, Inc. | 2024-07-02 |
| Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) (P810002/S123) | ABBOTT MEDICAL | 2024-07-02 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S081) | Edwards Lifesciences, LLC | 2024-07-02 |
| The Tendril MRI lead (P140033/S089) | ABBOTT MEDICAL | 2024-07-02 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S003) | Surmodics,Inc. | 2024-07-02 |
| INOUE BALLOON CATHETER (P910054/S010) | Toray Industries (America), Inc. | 2024-07-01 |
| Protege GPS Self-Expanding Peripheral Stent System (P060001/S042) | Medtronic Vascular, Inc. | 2024-07-01 |
| CapSureFix MRI Lead (P090013/S332) | Medtronic, Inc. | 2024-07-01 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S260) | Medtronic, Inc. | 2024-07-01 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S016) | Edwards Lifesciences, LLC | 2024-07-01 |
| RF Catheter Cables (P930029/S072) | Medtronic, Inc. | 2024-07-01 |
| Transvene CS/SVC Lead (P920015/S289) | Medtronic, Inc. | 2024-07-01 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S047) | Medtronic Vascular, Inc. | 2024-07-01 |
| CapSure SP Z Lead (P850089/S167) | Medtronic Cardiac Rhythm Disease Management | 2024-07-01 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+ VDD Lead (P890003/S468) | Medtronic, Inc. | 2024-07-01 |
| CapSure Sense Lead (P830061/S223) | Medtronic Cardiac Rhythm Disease Management | 2024-07-01 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S048) | Medtronic Vascular, Inc. | 2024-07-01 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S002) | Boston Scientific Corporation | 2024-06-28 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S045) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter IN.PACT 018 Paclitaxel-Co (P140010/S081) | Medtronic, Inc. | 2024-06-27 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S076) | Boston Scientific Corp | 2024-06-27 |
| MYNX CONTROL Venous Vascular Closure Device (VCD) 6F-12F (P040044/S097) | Cordis US Corporation | 2024-06-27 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S184) | Medtronic, Inc. | 2024-06-27 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S104) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S030) | Medtronic Vascular, Inc. | 2024-06-27 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S288) | Medtronic, Inc. | 2024-06-27 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S165) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| LifeVest Wearable Defibrillator, Model 5100 (P010030/S180) | Zoll Manufacturing Corporation | 2024-06-27 |
| Epsila EV Extravascular Lead (P220012/S028) | Medtronic, Inc. | 2024-06-27 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X (P980035/S783) | Medtronic, Inc. | 2024-06-27 |
| GORE TAG Thoracic Branch Endoprosthesis (P210032/S013) | W. L. Gore & Associates, Inc. | 2024-06-27 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S066) | Boston Scientific Scimed, Inc. | 2024-06-27 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S066) | Boston Scientific Corporation | 2024-06-27 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S541) | Medtronic, Inc. | 2024-06-27 |
| Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder (P120021/S024) | ABBOTT MEDICAL | 2024-06-26 |
| Amplatzer Muscular VSD Occluder (P040040/S046) | ABBOTT MEDICAL | 2024-06-26 |
| TREO Abdominal Stent-Graft System (P190015/S019) | Bolton Medical, Inc. | 2024-06-26 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S006) | ABBOTT MEDICAL | 2024-06-26 |
| LIFEPAK 35 Monitor/Defibrillator, LIFEPAK FLEX Battery (P160026/S050) | Physio-Control, Inc. | 2024-06-26 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S068) | ABBOTT MEDICAL | 2024-06-26 |
| Amplatzer Multifenestrated Septal Occluder Cribriform (P000039/S078) | ABBOTT MEDICAL | 2024-06-26 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S002) | ABBOTT MEDICAL | 2024-06-25 |
| INTELLANAV STABLEPOINT Ablation Catheter (P150005/S084) | Boston Scientific Corp | 2024-06-25 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S003) | ABBOTT MEDICAL | 2024-06-21 |
| Guardian System (P150009/S013) | Avertix Medical, Inc. | 2024-06-21 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System Onyx Frontier Zotarolimus Eluting Coronary Stent System (P160043/S075) | Medtronic Vascular | 2024-06-21 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S172) | Edwards Lifesciences, LLC | 2024-06-21 |
| LifeVest® Wearable Defibrillator (P010030/S181) | Zoll Manufacturing Corporation | 2024-06-21 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S002) | W. L. Gore & Associates, Inc. | 2024-06-21 |
| HV Splitter/Adaptor kit (P920015/S287) | Medtronic, Inc. | 2024-06-21 |
| Gore Excluder Conformable AAA Endoprosthesis (CEXC) (P200030/S017) | W. L. Gore and Associates, Inc. | 2024-06-21 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (P050023/S179) | Biotronik, Inc. | 2024-06-21 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S079) | Medtronic, Inc. | 2024-06-21 |
| Core Valve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Valve EnVeo R Delivery Catheter Sys (P130021/S164) | Medtronic, Inc. | 2024-06-20 |
| TriClip G4 Delivery System (P230007/S002) | ABBOTT MEDICAL | 2024-06-20 |
| MitraClip G4 Clip Delivery System (P100009/S065) | ABBOTT MEDICAL | 2024-06-20 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040) | Endotronix, Inc. | 2024-06-20 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S001) | Medtronic, Inc. | 2024-06-18 |
| FARAPULSE Pulsed Field Ablation System (P230030/S002) | Farapulse, Inc. | 2024-06-18 |