| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S061) | Edwards Lifesciences, LLC | 2025-03-04 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S088) | Edwards Lifesciences, LLC | 2025-03-04 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, SAPIEN 3 Ultra RESILIA Tra (P140031/S183) | Edwards Lifesciences, LLC | 2025-03-04 |
| EPi-Sense and EPi-Sense ST Guided Coagulation System (P200002/S010) | AtriCure, Inc. | 2025-03-03 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S048) | Biotronik AG | 2025-03-03 |
| EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) (P150048/S089) | Edwards Lifesciences, LLC | 2025-03-03 |
| Astron (P140030/S017) | Biotronik AG | 2025-03-03 |
| Pulsar-18 T3 (P160025/S019) | Biotronik AG | 2025-03-03 |
| DETOUR System (P220021/S004) | Endologix, LLC | 2025-03-03 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S184) | Edwards Lifesciences, LLC | 2025-03-03 |
| GORE® EXCLUDER AAA Endoprosthesis; Iliac Branch Endoprosthesis (P020004/S198) | W. L. Gore & Associates, Inc. | 2025-03-03 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S055) | Medtronic Vascular, Inc. | 2025-02-28 |
| Epsila EV Extravascular Lead (P220012/S042) | Medtronic, Inc. | 2025-02-27 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P950005/S088) | Biosense Webster, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P030031/S138) | Biosense Webster, Inc. | 2025-02-26 |
| HeartMate 3 (HM3) Left Ventricular Assist System (P160054/S097) | ABBOTT MEDICAL | 2025-02-26 |
| RelayPro Thoracic Stent-Graft System (P200045/S015) | Bolton Medical, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P010068/S074) | Biosense Webster, Inc. | 2025-02-26 |
| SmartAblate System Interface Cable (P990071/S065) | Biosense Webster, Inc. | 2025-02-26 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S883) | Medtronic Cardiac Rhythm Disease Management | 2025-02-26 |
| HeartMate II (HMII) Left Ventricular Assist System (P060040/S114) | ABBOTT MEDICAL | 2025-02-26 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S917) | Medtronic Cardiac Rhythm Disease Management | 2025-02-26 |
| TX eco EXT Cable (P210027/S014) | Biosense Webster, Inc. | 2025-02-26 |
| Attain Ability Lead (P080006/S189) | Medtronic, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P240006/S002) | Biosense Webster, Inc. | 2025-02-26 |
| Thermocool Deflectable Diagnostic/ Ablation Catheter (P040036/S100) | Biosense Webster, Inc. | 2025-02-25 |
| NAVISTAR DS Electrophysiology Catheter (P010068/S075) | Biosense Webster, Inc. | 2025-02-25 |
| QDOT MICRO System (P210027/S015) | Biosense Webster, Inc. | 2025-02-25 |
| Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe (P030031/S139) | Biosense Webster, Inc. | 2025-02-25 |
| NAVISTAR Electrophysiology Catheter (P990025/S074) | Biosense Webster, Inc. | 2025-02-25 |
| Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst (P960043/S126) | Abbott Vascular, Inc. | 2025-02-24 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S060) | Edwards Lifesciences, LLC | 2025-02-24 |
| GORE® VIABAHN® Endoprosthesis (P040037/S167) | W. L. Gore & Associates, Inc. | 2025-02-21 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S106) | W. L. Gore & Associates, Inc. | 2025-02-21 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S897) | Medtronic Cardiac Rhythm Disease Management | 2025-02-20 |
| EDWARDS INTUITY Elite Valve System, INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Va (P150048/S087) | Edwards Lifesciences, LLC | 2025-02-20 |
| 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/S806) | Medtronic, Inc. | 2025-02-20 |
| RX Acculink Carotid Stent System (P040012/S065) | Abbott Vascular | 2025-02-20 |
| CapSureFix Novus Lead (P930039/S269) | Medtronic, Inc. | 2025-02-20 |
| CapSure Sense Lead (P830061/S229) | Medtronic Cardiac Rhythm Disease Management | 2025-02-20 |
| 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/S194) | Biotronik, Inc. | 2025-02-20 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S166) | Biotronik, Inc. | 2025-02-20 |
| Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses (P860057/S221) | Edwards Lifesciences, LLC | 2025-02-20 |
| Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield (P810002/S124) | ABBOTT MEDICAL | 2025-02-20 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S863) | Medtronic Cardiac Rhythm Disease Management | 2025-02-20 |
| 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/S270) | Biotronik, Inc. | 2025-02-20 |
| EDWARDS INTUITY Elite Valve System (P150036/S077) | Edwards Lifesciences, LLC | 2025-02-20 |
| Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medtronic Evolut Pro+ Transcatheter Aortic Valve, Medtroni (P130021/S170) | Medtronic, Inc. | 2025-02-19 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S003) | Biosense Webster, Inc. | 2025-02-18 |
| FARAPULSE Pulsed Field Ablation System (P230030/S009) | Farapulse, Inc. | 2025-02-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S096) | ABBOTT MEDICAL | 2025-02-18 |
| HeartMate II Left Ventricular Assist System (P060040/S113) | ABBOTT MEDICAL | 2025-02-18 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S023) | Biotronik AG | 2025-02-14 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S050) | Biotronik AG | 2025-02-14 |
| Aurora EV-ICD (P220012/S040) | Medtronic, Inc. | 2025-02-14 |
| DETOUR System (P220021/S002) | Endologix, LLC | 2025-02-14 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S199) | Medtronic, Inc. | 2025-02-14 |
| 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, Cobalt (P010031/S881) | Medtronic Cardiac Rhythm Disease Management | 2025-02-14 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S049) | Biotronik AG | 2025-02-14 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, (P980016/S915) | Medtronic Cardiac Rhythm Disease Management | 2025-02-14 |
| HeartMate 3 Left Ventricular Assist System (P160054/S095) | ABBOTT MEDICAL | 2025-02-13 |
| Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S431) | ABBOTT MEDICAL | 2025-02-13 |
| Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify (P910023/S475) | ABBOTT MEDICAL | 2025-02-13 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic E (P130021/S169) | Medtronic, Inc. | 2025-02-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S037) | Boston Scientific Corporation | 2025-02-12 |
| Harmony Transcatheter Pulmonary Valve (P200046/S036) | Medtronic, Inc. | 2025-02-12 |
| LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft (P220025/S005) | LimFlow, Inc. | 2025-02-12 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S010) | Edwards Lifesciences, LLC | 2025-02-11 |
| Duo Venous Stent System (P230021/S001) | Philips Image Guided Therapy Corporation | 2025-02-11 |
| SMARTABLATE Irrigation Tubing Set (P990071/S063) | Biosense Webster, Inc. | 2025-02-11 |
| XACT® Carotid Stent System (P040038/S046) | Abbott Vascular, Inc. | 2025-02-10 |
| Supera Peripheral Stent System (P120020/S032) | Abbott Vascular (Idef Technologies Inc) | 2025-02-10 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S197) | W. L. Gore & Associates, Inc. | 2025-02-10 |
| SMARTFREEZE Cryo-Cable (P220032/S009) | Boston Scientific Corporation | 2025-02-10 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System (P100009/S070) | ABBOTT MEDICAL | 2025-02-10 |
| Perclose ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System (P960043/S124) | Abbott Vascular, Inc. | 2025-02-10 |
| TriClip G4 System, TriClip G5 Delivery System (P230007/S009) | ABBOTT MEDICAL | 2025-02-10 |
| StarClose SE® Vascular Surgical System (P050007/S045) | Abbott Vascular Devices | 2025-02-10 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S008) | Farapulse, Inc. | 2025-02-08 |
| Micra AV TPS, Micra TPS (P150033/S200) | Medtronic, Inc. | 2025-02-06 |
| CardioMEMS HF System (P100045/S077) | ABBOTT MEDICAL | 2025-02-06 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S205) | ABBOTT MEDICAL | 2025-02-05 |
| Tendril STS, UltiPace (P960013/S127) | ABBOTT MEDICAL | 2025-02-05 |
| WOLVERINE Coronary Cutting Balloon (P950020/S146) | Boston Scientific Corp | 2025-02-05 |
| Durata, Optisure (P950022/S146) | ABBOTT MEDICAL | 2025-02-05 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S470) | ABBOTT MEDICAL | 2025-02-05 |
| 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/S134) | Biotronik, Inc. | 2025-02-05 |
| Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers (P140033/S093) | ABBOTT MEDICAL | 2025-02-05 |
| Aveir Leadless System (P150035/S017) | ABBOTT MEDICAL | 2025-02-05 |
| Microny family of Pacemakers (P970013/S096) | ABBOTT MEDICAL | 2025-02-05 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S117) | Biotronik, Inc. | 2025-02-05 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu (P030054/S426) | ABBOTT MEDICAL | 2025-02-05 |
| 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/S268) | Biotronik, Inc. | 2025-02-05 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S339) | ABBOTT MEDICAL | 2025-02-05 |
| 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/S191) | Biotronik, Inc. | 2025-02-05 |
| SYNERGYXD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chr (P150003/S107) | Boston Scientific Corporation | 2025-02-05 |
| Impella CP with SmartAssist (P140003/S122) | Abiomed, Inc. | 2025-02-04 |
| CentriMag Circulatory Support System (P170038/S017) | Abbott | 2025-02-04 |