| Pulsar-18 T3 Stent System (P160025/S022) | Biotronik AG | 2025-10-21 |
| PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (P030047/S052) | Cordis US Corporation | 2025-10-21 |
| Astron Peripheral Self- Expanding Nitinol Stent System (P140030/S021) | Biotronik AG | 2025-10-21 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| MITRACLIP DELIVERY SYSTEM (P100009/S081) | ABBOTT MEDICAL | 2025-10-17 |
| HeartMate Apical Coring Knife (P060040/S112) | ABBOTT MEDICAL | 2025-10-17 |
| XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS) (P040038/S050) | Abbott Vascular, Inc. | 2025-10-17 |
| HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System (P160054/S094) | ABBOTT MEDICAL | 2025-10-17 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010) (P920047/S138) | Boston Scientific Corp | 2025-10-17 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) (P150005/S091) | Boston Scientific Corp | 2025-10-17 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) (P020025/S147) | Boston Scientific | 2025-10-17 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| TriClip G4 System (P230007/S018) | ABBOTT MEDICAL | 2025-10-17 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S089) | ABBOTT MEDICAL | 2025-10-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (P140031/S195) | Edwards Lifesciences, LLC | 2025-10-16 |
| INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve (P150048/S093) | Edwards Lifesciences, LLC | 2025-10-16 |
| Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (P000009/S123) | Biotronik, Inc. | 2025-10-16 |
| Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 (P980023/S139) | Biotronik, Inc. | 2025-10-16 |
| EDWARDS INTUITY Elite Valve (P150036/S078) | Edwards Lifesciences, LLC | 2025-10-16 |
| Thoraflex Hybrid (P210006/S014) | Vascutek, Ltd. | 2025-10-16 |
| Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi (P860057/S223) | Edwards Lifesciences, LLC | 2025-10-16 |
| Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (P950037/S278) | Biotronik, Inc. | 2025-10-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S071) | Edwards Lifesciences, LLC | 2025-10-16 |
| Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H (P070008/S171) | Biotronik, Inc. | 2025-10-16 |
| Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I (P050023/S203) | Biotronik, Inc. | 2025-10-16 |
| Masters Series Mechanical Heart Valve (P810002/S125) | ABBOTT MEDICAL | 2025-10-15 |
| GORE® TAG® Conformable Thoracic Endoprosthesis (P040043/S147) | W. L. Gore & Associates, Inc. | 2025-10-15 |
| FlexNav Delivery System; Navitor Transcatheter Aortic Valves (P190023/S028) | ABBOTT MEDICAL | 2025-10-15 |
| LIFEPAK 1000 defibrillator (P160026/S062) | Physio-Control, Inc. | 2025-10-14 |
| Shockwave lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter (P200039/S018) | Shockwave Medical, Inc. | 2025-10-14 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S033) | Bolton Medical, Inc. | 2025-10-10 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S056) | Biotronik AG | 2025-10-10 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S194) | Edwards Lifesciences, LLC | 2025-10-10 |
| DiamondTemp Ablation System (P200028/S026) | Medtronic, Inc. | 2025-10-10 |
| GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis (P020004/S204) | W. L. Gore & Associates, Inc. | 2025-10-09 |
| HeartMate 3 Left Ventricular Assist System (P160054/S113) | ABBOTT MEDICAL | 2025-10-09 |
| DETOUR System (P220021/S006) | Endologix, LLC | 2025-10-09 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S154) | Medtronic Cardiac Rhythm Disease Management | 2025-10-09 |
| 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/S824) | Medtronic, Inc. | 2025-10-08 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S573) | Medtronic, Inc. | 2025-10-08 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S008) | Medtronic, Inc. | 2025-10-08 |
| RelayPro Thoracic Stent-Graft System (P200045/S018) | Bolton Medical, Inc. | 2025-10-07 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S017) | Medtronic, Inc. | 2025-10-07 |
| EPi-Sense Guided Coagulation System (P200002/S012) | AtriCure, Inc. | 2025-10-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S104) | ABBOTT MEDICAL | 2025-10-06 |
| CorPASS System (P230040/S022) | Endotronix, Inc. | 2025-10-06 |
| Tendyne Transcatheter Mitral Valve System (P240042/S002) | ABBOTT MEDICAL | 2025-10-04 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S903) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRTD DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI CR (P010031/S904) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (P980016/S937) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S572) | Medtronic, Inc. | 2025-10-03 |
| WiSE (Wireless Stimulation of the Endocardium Technology) CRT System (P240028/S003) | EBR Systems, Inc. | 2025-10-03 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (P980016/S938) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| Aurora EV ICD (DVEA3E4) (P220012/S058) | Medtronic, Inc. | 2025-10-03 |
| Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra (P980035/S823) | Medtronic, Inc. | 2025-10-03 |
| GORE® TAG® Conformable Thoracic Endoprosthesis (P040043/S146) | W. L. Gore & Associates, Inc. | 2025-10-02 |
| 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/S825) | Medtronic, Inc. | 2025-10-02 |
| EverFlex Self-expanding Peripheral Stent System (P110023/S062) | Medtronic Vascular, Inc. | 2025-10-02 |
| 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/S822) | Medtronic, Inc. | 2025-10-02 |
| Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (P200015/S070) | Edwards Lifesciences, LLC | 2025-10-02 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S056) | Medinol, Ltd. | 2025-10-02 |
| PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (P220003/S026) | Edwards Lifesciences, LLC | 2025-10-02 |
| Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (P140031/S193) | Edwards Lifesciences, LLC | 2025-10-02 |
| Percepta Bipolar CRTP; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P; (P010015/S571) | Medtronic, Inc. | 2025-10-02 |
| Ilivia 7 VR-T DX; Intica 7 VR-T DX; Intica 5 VR-T DX; Ilivia 7 VR-T; Ilivia 7 DF4 VR-T; Intica 7 VR-T; Intica 7 DF4 VR-T (P050023/S202) | Biotronik, Inc. | 2025-10-01 |
| Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (P950037/S277) | Biotronik, Inc. | 2025-10-01 |
| Impella 5.5 with SmartAssist (P140003/S131) | Abiomed, Inc. | 2025-10-01 |
| Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T (P000009/S122) | Biotronik, Inc. | 2025-10-01 |
| Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (P980023/S138) | Biotronik, Inc. | 2025-10-01 |
| TriClip G4 Delivery System; TriClip G5 Delivery System (P230007/S017) | ABBOTT MEDICAL | 2025-09-30 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S020) | Endotronix, Inc. | 2025-09-30 |
| AVEIR Leadless Pacemaker Real-time Clock (RTC) electrical test (P150035/S032) | ABBOTT MEDICAL | 2025-09-30 |
| MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (P100009/S080) | ABBOTT MEDICAL | 2025-09-30 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S021) | Endotronix, Inc. | 2025-09-29 |
| LIFEPACK® CR2 Automated External Defibrillator (AED) (P170018/S024) | Physio-Control, Inc. | 2025-09-29 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S030) | Heartsine Technologies, Ltd. | 2025-09-29 |
| CentriMag Circulatory Support System (P170038/S023) | Abbott | 2025-09-29 |
| ZOLL Zenix® Monitor/Defibrillator (P160022/S036) | ZOLL Medical Corporation | 2025-09-29 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S014) | Bard Peripheral Vascular, Inc. | 2025-09-29 |
| VenaSeal Closure System (P140018/S047) | Medtronic Vascular, Inc. | 2025-09-26 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S015) | ABBOTT MEDICAL | 2025-09-26 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S020) | Edwards Lifesciences, LLC | 2025-09-25 |
| CardioMEMS HF System (P100045/S079) | ABBOTT MEDICAL | 2025-09-24 |
| AVEIR Patient Transmitter (model, LSRM01), AVEIR Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T (P150035/S028) | ABBOTT MEDICAL | 2025-09-24 |
| FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul (P230030/S013) | Farapulse, Inc. | 2025-09-24 |
| Impella CP with SmartAssist (P140003/S130) | Abiomed, Inc. | 2025-09-24 |
| Abre Venous Self-expanding Stent System (P200026/S014) | Medtronic Vascular, Inc. | 2025-09-23 |
| VenaSeal Closure System (P140018/S046) | Medtronic Vascular, Inc. | 2025-09-23 |
| CPR Uni-padz Electrode (P160022/S047) | ZOLL Medical Corporation | 2025-09-22 |
| Accolade MRI Pacemakers, ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI ( (P150012/S170) | Boston Scientific | 2025-09-22 |
| CPR-D-padz Electrode (P160015/S026) | ZOLL Medical Corporation | 2025-09-22 |
| Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model (P030005/S248) | Guidant Corp. | 2025-09-22 |
| Cardiac Resynchronization Therapy Defibrillators INOGEN (Models G140, G141, G146, G148); DYNAGEN (Models G150, G151, G15 (P010012/S595) | Boston Scientific Corp | 2025-09-22 |
| Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models (P960040/S508) | Boston Scientific | 2025-09-22 |
| Navitor Transcatheter Aortic Valve Implantation System (P190023/S027) | ABBOTT MEDICAL | 2025-09-22 |
| Accolade Non-MRI Pacemakers ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models (N970003/S302) | Boston Scientific Corp | 2025-09-22 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S016) | Medtronic, Inc. | 2025-09-19 |
| Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (P140003/S129) | Abiomed, Inc. | 2025-09-19 |