| EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter (P010068/S073) | Biosense Webster, Inc. | 2024-11-20 |
| QDOT Micro Uni-Directional Navigation Catheter, QDOT Micro Bi-Directional Navigation Catheter (P210027/S013) | Biosense Webster, Inc. | 2024-11-20 |
| NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T (P030031/S137) | Biosense Webster, Inc. | 2024-11-20 |
| 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/S872) | Medtronic Cardiac Rhythm Disease Management | 2024-11-20 |
| NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol (P990025/S073) | Biosense Webster, Inc. | 2024-11-20 |
| Aurora EV ICD (P220012/S034) | Medtronic, Inc. | 2024-11-20 |
| Cardiva VASCADE MVP XL Venous Vascular Closure System (VVCS) (P120016/S037) | Cardiva Medical, Inc. | 2024-11-19 |
| HeartMate 3 Left Ventricular Assist System (P160054/S091) | ABBOTT MEDICAL | 2024-11-19 |
| HeartMate 3 Left Ventricular Assist System (P160054/S089) | ABBOTT MEDICAL | 2024-11-19 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S042) | Boston Scientific Corp | 2024-11-19 |
| TREO® Abdominal Stent-Graft System (P190015/S022) | Bolton Medical, Inc. | 2024-11-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S090) | ABBOTT MEDICAL | 2024-11-18 |
| Conformable Gore® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S137) | W. L. Gore & Associates, Inc. | 2024-11-18 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S005) | W. L. Gore & Associates, Inc. | 2024-11-18 |
| RelayPro Thoracic Stent-Graft System (P200045/S014) | Bolton Medical, Inc. | 2024-11-18 |
| Valiant Thoratic Stent Graft with Captivia Delivery System (P100040/S064) | Medtronic Vascular | 2024-11-18 |
| nMARQ Catheter Interference Cable (P950005/S087) | Biosense Webster, Inc. | 2024-11-15 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F), Mynx Control Venous Vasc (P040044/S105) | Cordis US Corporation | 2024-11-15 |
| nMARQ Catheter Interference Cable (P030031/S135) | Biosense Webster, Inc. | 2024-11-15 |
| Smartablate System Interface Cable (P990071/S060) | Biosense Webster, Inc. | 2024-11-15 |
| nMARQ Catheter Interference Cable (P990025/S072) | Biosense Webster, Inc. | 2024-11-15 |
| nMARQ Catheter Interference Cable (P010068/S072) | Biosense Webster, Inc. | 2024-11-15 |
| nMARQ Catheter Interference Cable (P040036/S097) | Biosense Webster, Inc. | 2024-11-15 |
| MYNXGRIP Vascular Closure Device (5F, 6F/7F), MYNX CONTROL Vascular Closure Device (5F, 6F/7F), MYNX CONTROL VENOUS Vasc (P040044/S106) | Cordis US Corporation | 2024-11-15 |
| TX eco Extension Cable (P210027/S008) | Biosense Webster, Inc. | 2024-11-15 |
| Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (P240009/S002) | Contego Medical, Inc. | 2024-11-15 |
| CardioMEMS HF System (P100045/S078) | ABBOTT MEDICAL | 2024-11-15 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection (P240009/S001) | Contego Medical, Inc. | 2024-11-15 |
| Carelink SmartSync Platform Carelink SmartSync TM Common Application (P890003/S469) | Medtronic, Inc. | 2024-11-15 |
| R Series (P160022/S039) | ZOLL Medical Corporation | 2024-11-15 |
| CareLink SmartSync NuPace Application Software (P890003/S471) | Medtronic, Inc. | 2024-11-14 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S018) | W. L. Gore & Associates, Inc. | 2024-11-14 |
| CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura (P980016/S901) | Medtronic Cardiac Rhythm Disease Management | 2024-11-14 |
| CareLink SmartSync Claria Amplia Compia App, CareLink SmartSync Cobalt, Crome App, CareLink SmartSync Viva Brava Evera A (P010031/S867) | Medtronic Cardiac Rhythm Disease Management | 2024-11-14 |
| SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S180) | Edwards Lifesciences, LLC | 2024-11-14 |
| CareLink SmartSync Percepta Serena Solara App (P010015/S545) | Medtronic, Inc. | 2024-11-14 |
| CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App (P150033/S191) | Medtronic, Inc. | 2024-11-14 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S006) | Endotronix, Inc. | 2024-11-14 |
| Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl (P150005/S086) | Boston Scientific Corp | 2024-11-14 |
| CareLink SmartSync Azure Astra App (P980035/S790) | Medtronic, Inc. | 2024-11-14 |
| MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System (P140002/S028) | Terumo Medical Corporation | 2024-11-14 |
| BioMimics 3D® Vascular Stent System (P180003/S011) | Veryan Medical, Ltd. | 2024-11-14 |
| HeartMate 3 Left Ventricular Assist System (P160054/S088) | ABBOTT MEDICAL | 2024-11-14 |
| INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve (P150048/S084) | Edwards Lifesciences, LLC | 2024-11-14 |
| Coaxial Umbilical Cable (P020045/S111) | Medtronic Cryocath, LP | 2024-11-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S193) | Medtronic, Inc. | 2024-11-13 |
| End Cap, Epicardial Patch Lead, Sizing Sleeve (P900061/S174) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Manual Retraction Kit (P100010/S149) | Medtronic Cryocath, LP | 2024-11-13 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S265) | Medtronic, Inc. | 2024-11-13 |
| 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/S871) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le (P920015/S294) | Medtronic, Inc. | 2024-11-13 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S473) | Medtronic, Inc. | 2024-11-13 |
| CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead (P850089/S170) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Myocardial Pacing Lead (P120017/S037) | Medtronic, Inc. | 2024-11-13 |
| CapSure Sense Lead, CapSure SP Lead, Vitatron Crystalline Lead (P830061/S226) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S150) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Aurora EV ICD, Epsila EV Extravascular Lead (P220012/S033) | Medtronic, Inc. | 2024-11-13 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S187) | Medtronic, Inc. | 2024-11-13 |
| Transvene CS/SVC Lead (P980050/S144) | Medtronic, Inc. | 2024-11-13 |
| CapSureFix MRI Lead (P090013/S334) | Medtronic, Inc. | 2024-11-13 |
| Attain StarFix Lead (P060039/S117) | Medtronic, Inc. | 2024-11-13 |
| Azure/Astra Implantable Pulse Generator (IPG) (P980035/S788) | Medtronic, Inc. | 2024-11-13 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Solara (P010015/S549) | Medtronic, Inc. | 2024-11-13 |
| 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/S905) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| CapSure Epicardial Pacing Lead (P950024/S113) | Medtronic, Inc. | 2024-11-13 |
| 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/S797) | Medtronic, Inc. | 2024-11-13 |
| TriClip G4 System (P230007/S007) | ABBOTT MEDICAL | 2024-11-13 |
| CPR Uni-padz III (P160015/S016) | ZOLL Medical Corporation | 2024-11-12 |
| CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro- (P160022/S038) | ZOLL Medical Corporation | 2024-11-12 |
| Angio-Seal Vascular Closure Device (P930038/S103) | Terumo Medical Corporation | 2024-11-08 |
| Minima Stent System (P240003/S001) | Renata Medical, Inc. | 2024-11-08 |
| INGEVITY+ (P150012/S162) | Boston Scientific | 2024-11-08 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S083) | Edwards Lifesciences, LLC | 2024-11-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S021) | Edwards Lifesciences, LLC | 2024-11-07 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S032) | Boston Scientific Corporation | 2024-11-07 |
| LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC, (P910073/S180) | Boston Scientific | 2024-11-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S179) | Edwards Lifesciences, LLC | 2024-11-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S059) | Edwards Lifesciences, LLC | 2024-11-07 |
| EMBLEM S-ICD ELECTRODE 45 CM 3501 (P110042/S200) | Boston Scientific Corporation | 2024-11-07 |
| NAV 2 Quadpole LV Straight 86CM 4671, NAV 2 Quadpole LV Straight 95CM 4672, NAV 2 Quadpole LV Short Spiral 86CM 4674, N (P010012/S587) | Boston Scientific Corp | 2024-11-07 |
| GUARDIO/VESTA charger (P180036/S032) | Impulse Dynamics (Usa), Inc. | 2024-11-06 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006) | Biosense Webster, Inc. | 2024-11-06 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG (P980035/S798) | Medtronic, Inc. | 2024-11-05 |
| CentriMag Circulatory Support System (P170038/S022) | Abbott | 2024-11-05 |
| Consulta CRT-P, Syncra CRT-P (P010015/S550) | Medtronic, Inc. | 2024-11-05 |
| ACCOLADE (N970003/S295) | Boston Scientific Corp | 2024-11-01 |
| Amplatzer Muscular VSD Occluder (P040040/S048) | ABBOTT MEDICAL | 2024-11-01 |
| ACCOLADE (P030005/S241) | Guidant Corp. | 2024-11-01 |
| CentriMag Circulatory Support System (P170038/S021) | Abbott | 2024-11-01 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S072) | Boston Scientific Corp | 2024-11-01 |
| ACCOLADE (P150012/S160) | Boston Scientific | 2024-11-01 |
| Aurora EV ICD (P220012/S031) | Medtronic, Inc. | 2024-10-30 |
| 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/S902) | Medtronic Cardiac Rhythm Disease Management | 2024-10-30 |
| 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/S868) | Medtronic Cardiac Rhythm Disease Management | 2024-10-30 |
| nGEN Pump (P990071/S061) | Biosense Webster, Inc. | 2024-10-30 |
| Impella CP with SmartAssist (P140003/S121) | Abiomed, Inc. | 2024-10-29 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S020) | Edwards Lifesciences, LLC | 2024-10-29 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S043) | Cardiovascular Systems, Inc. | 2024-10-28 |
| Assurity, Assurity +, Endurity, Endurity Core, Zenus, Zenex, Accent (P880086/S340) | ABBOTT MEDICAL | 2024-10-28 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S062) | Boston Scientific Corp | 2024-10-28 |