| Sphere-9 Catheter and Affera Ablation System (P240013/S003) | Medtronic, Inc. | 2025-02-03 |
| LIFEPAK® 1000 Defibrillator (P160026/S056) | Physio-Control, Inc. | 2025-02-03 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S007) | Endotronix, Inc. | 2025-02-03 |
| LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026/S055) | Physio-Control, Inc. | 2025-01-31 |
| BAROSTIM NEO® System (P180050/S013) | Cvrx, Inc. | 2025-01-30 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S916) | Medtronic Cardiac Rhythm Disease Management | 2025-01-30 |
| Aurora EV ICD (P220012/S041) | Medtronic, Inc. | 2025-01-30 |
| Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt M (P010031/S882) | Medtronic Cardiac Rhythm Disease Management | 2025-01-30 |
| Avive Automated External Defibrillator (AED) System (P210015/S005) | Avive Solutions, Inc. | 2025-01-29 |
| Thoraflex Hybrid (P210006/S011) | Vascutek, Ltd. | 2025-01-27 |
| LIFEPAK® 15 monitor (P160026/S054) | Physio-Control, Inc. | 2025-01-27 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi (P150003/S105) | Boston Scientific Corporation | 2025-01-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per (P140010/S088) | Medtronic, Inc. | 2025-01-24 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S037) | Medtronic Vascular, Inc. | 2025-01-24 |
| Perceval Sutureless Heart Valve, Perceval PLUS Sutureless Heart Valve (P150011/S030) | Corcym S.r.l. | 2025-01-24 |
| CELT ACD PLUS Vascular Closure Device (P150006/S006) | Vasorum, Ltd. | 2025-01-24 |
| Paradise Ultrasound Renal Denervation System (Paradise System), Paradise Catheter (P220023/S006) | Recor Medical, Inc. | 2025-01-24 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S014) | Cook Medical Incorporated | 2025-01-23 |
| Mosaic Bioprosthesis (P990064/S089) | Medtronic, Inc. | 2025-01-22 |
| nGEN Pump (P990071/S064) | Biosense Webster, Inc. | 2025-01-22 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S188) | Medtronic, Inc. | 2025-01-22 |
| Aurora EV-ICD (P220012/S039) | Medtronic, Inc. | 2025-01-22 |
| Hancock II Bioprosthesis (P980043/S080) | Medtronic, Inc. | 2025-01-22 |
| 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/S880) | Medtronic Cardiac Rhythm Disease Management | 2025-01-22 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S914) | Medtronic Cardiac Rhythm Disease Management | 2025-01-22 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S054) | Medtronic Vascular, Inc. | 2025-01-21 |
| PERCEVAL PLUS SUTURELESS HEART VALVE (P150011/S031) | Corcym S.r.l. | 2025-01-21 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S010) | Endotronix, Inc. | 2025-01-17 |
| Rotawire Guidewire, ROTAWIRE Drive Guidewire (P900056/S218) | Boston Scientific Corp | 2025-01-17 |
| GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder (P050006/S111) | W. L. Gore & Associates, Inc. | 2025-01-17 |
| Minima Stent System (P240003/S002) | Renata Medical, Inc. | 2025-01-16 |
| Aveir VR Leadless Pacemaker, Aveir DR Leadless Pacemaker (P150035/S021) | ABBOTT MEDICAL | 2025-01-16 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S036) | Spectranetics Corp. | 2025-01-15 |
| Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno (P120016/S038) | Cardiva Medical, Inc. | 2025-01-15 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S005) | Boston Scientific Corporation | 2025-01-14 |
| PROMUS Element PLUS, PREMIER, ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S213) | Boston Scientific Corp | 2025-01-14 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S870) | Medtronic Cardiac Rhythm Disease Management | 2025-01-14 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S065) | Boston Scientific Corp | 2025-01-14 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S036) | Boston Scientific Corporation | 2025-01-14 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co (P150003/S106) | Boston Scientific Corporation | 2025-01-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S904) | Medtronic Cardiac Rhythm Disease Management | 2025-01-14 |
| 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/S796) | Medtronic, Inc. | 2025-01-14 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S548) | Medtronic, Inc. | 2025-01-14 |
| Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S055) | Abiomed, Inc. | 2025-01-10 |
| CorPASS System (P230040/S009) | Endotronix, Inc. | 2025-01-10 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S005) | Medtronic, Inc. | 2025-01-09 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S198) | Medtronic, Inc. | 2025-01-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S912) | Medtronic Cardiac Rhythm Disease Management | 2025-01-08 |
| CareLink SmartSync Device Manager Base, CareLink SmartSync Device Manager Patient Connector, MyCareLink Patient Monitor (P890003/S474) | Medtronic, Inc. | 2025-01-08 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S557) | Medtronic, Inc. | 2025-01-08 |
| Aurora EV ICD (P220012/S038) | Medtronic, Inc. | 2025-01-08 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S805) | Medtronic, Inc. | 2025-01-08 |
| 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/S878) | Medtronic Cardiac Rhythm Disease Management | 2025-01-08 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S004) | Medtronic, Inc. | 2025-01-07 |
| LifeVest Wearable Defibrillator (P010030/S190) | Zoll Manufacturing Corporation | 2025-01-07 |
| Navitor Transcatheter Aortic Valve Implantation (TAVI) System (P190023/S024) | ABBOTT MEDICAL | 2025-01-06 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S556) | Medtronic, Inc. | 2025-01-03 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S007) | W. L. Gore & Associates, Inc. | 2025-01-03 |
| 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/S804) | Medtronic, Inc. | 2025-01-03 |
| MANTA Vascular Closure Device (P180025/S013) | Teleflex Medical, LLC | 2025-01-03 |
| TriClip G5 Delivery System (P230007/S005) | ABBOTT MEDICAL | 2024-12-31 |
| MitraClip G5 System (P100009/S067) | ABBOTT MEDICAL | 2024-12-31 |
| Sphere-9 Mapping and Ablation Catheter (P240013/S005) | Medtronic, Inc. | 2024-12-23 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S004) | W. L. Gore & Associates, Inc. | 2024-12-23 |
| Sphere-9 Mapping and Ablation Catheter, Tubing Set (P240013/S004) | Medtronic, Inc. | 2024-12-23 |
| LimFlow System (P220025/S004) | LimFlow, Inc. | 2024-12-20 |
| Avant HF, Neutrino NxT HF, Gallant HF, Neutrino NxT HF, Entrant HF (P030054/S408) | ABBOTT MEDICAL | 2024-12-20 |
| Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR (P910023/S455) | ABBOTT MEDICAL | 2024-12-20 |
| Zilver PTX Peripheral Drug-Eluting Stent (P100022/S043) | Cook Ireland, Ltd. | 2024-12-20 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S005) | Surmodics,Inc. | 2024-12-20 |
| Endurant Stent Graft System (P100021/S127) | Medtronic Vascular | 2024-12-20 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S070) | Medtronic Vascular | 2024-12-20 |
| Paradise Ultrasound Renal Denervation System, Paradise Cartridge, Paradise Generator (P220023/S004) | Recor Medical, Inc. | 2024-12-20 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S228) | Medtronic Cardiac Rhythm Disease Management | 2024-12-19 |
| Assurity, Assurity +, Endurity, Endurity Core, Endurity, Endurity Core, Zenus, Zenex (P880086/S341) | ABBOTT MEDICAL | 2024-12-19 |
| Avant, Neutrino NxT, Gallant, Entrant (P030054/S430) | ABBOTT MEDICAL | 2024-12-19 |
| Sprint Quattro Lead (P920015/S295) | Medtronic, Inc. | 2024-12-19 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |
| OPTIMIZER Smart System (P180036/S036) | Impulse Dynamics (Usa), Inc. | 2024-12-19 |
| Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S095) | ABBOTT MEDICAL | 2024-12-19 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Serena Quadripolar C (P010015/S554) | Medtronic, Inc. | 2024-12-19 |
| Paradise Ultrasound Renal Denervation System, Paradise Generator (P220023/S005) | Recor Medical, Inc. | 2024-12-19 |
| TherOx Downstream System (P170027/S017) | Zoll Circulation, Inc. | 2024-12-19 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S045) | Berlin Heart, Inc. | 2024-12-19 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S195) | Medtronic, Inc. | 2024-12-19 |
| Avant, Neutrino NxT, Gallant, Entrant (P910023/S474) | ABBOTT MEDICAL | 2024-12-19 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S803) | Medtronic, Inc. | 2024-12-19 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP (P030035/S207) | ABBOTT MEDICAL | 2024-12-19 |
| Micra Transcatheter Pacing System (P150033/S197) | Medtronic, Inc. | 2024-12-19 |
| Microny family of Pacemakers (P970013/S095) | ABBOTT MEDICAL | 2024-12-18 |
| 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/S795) | Medtronic, Inc. | 2024-12-18 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S204) | ABBOTT MEDICAL | 2024-12-18 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S298) | Boston Scientific Corp | 2024-12-18 |
| 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/S802) | Medtronic, Inc. | 2024-12-18 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S425) | ABBOTT MEDICAL | 2024-12-18 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S111) | ABBOTT MEDICAL | 2024-12-18 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S164) | Boston Scientific | 2024-12-18 |
| Artegraft Collagen Vascular Graft (N16837/S035) | LeMaitre Vascular, Inc. | 2024-12-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, (P980016/S911) | Medtronic Cardiac Rhythm Disease Management | 2024-12-18 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S244) | Guidant Corp. | 2024-12-18 |