| Ilivia Neo 7 DR-T (P000009/S111) | Biotronik, Inc. | 2024-05-19 |
| Intica Neo 7 HF -T, Intica Neo 7 HF -T QP, BS IS4 (P050023/S184) | Biotronik, Inc. | 2024-05-19 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S158) | Biotronik, Inc. | 2024-05-19 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S021) | Biotronik AG | 2024-05-17 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S038) | Biotronik AG | 2024-05-17 |
| LifeVest Wearable Defibrillator (P010030/S177) | Zoll Manufacturing Corporation | 2024-05-16 |
| GORE TAG Conformable Thoracic Stent Graft with Active Control System (P040043/S136) | W. L. Gore & Associates, Inc. | 2024-05-15 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S011) | Kestra Medical Technologies, Inc. | 2024-05-14 |
| Entrant VR ICD, Entrant DR ICD, Gallant VR ICD, Gallant DR ICD Neutrino NxT VR ICD, Neutrino NxT DR ICD (P910023/S465) | ABBOTT MEDICAL | 2024-05-14 |
| Zilver® Vascular Stent (P050017/S023) | Cook Ireland, Ltd. | 2024-05-14 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S079) | ABBOTT MEDICAL | 2024-05-14 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S008) | Cook Ireland, Ltd. | 2024-05-14 |
| Entrant CRT-D, Gallant CRT D, Neutrino NxT HF CRT-D (P030054/S420) | ABBOTT MEDICAL | 2024-05-14 |
| CardioMEMS HF System (P100045/S075) | ABBOTT MEDICAL | 2024-05-13 |
| CardioMEMS HF System (P100045/S073) | ABBOTT MEDICAL | 2024-05-13 |
| BioMimics 3D® Vascular Stent (P180003/S009) | Veryan Medical, Ltd. | 2024-05-10 |
| TriClip G4 Clip Delivery System (P230007/S001) | ABBOTT MEDICAL | 2024-05-09 |
| 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, Compia (P010031/S847) | Medtronic Cardiac Rhythm Disease Management | 2024-05-09 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S881) | Medtronic Cardiac Rhythm Disease Management | 2024-05-09 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves (P140031/S173) | Edwards Lifesciences, LLC | 2024-05-09 |
| Aurora EV ICD (P220012/S014) | Medtronic, Inc. | 2024-05-09 |
| Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF T QP, Rivacor 5 HF T (P050023/S180) | Biotronik, Inc. | 2024-05-09 |
| Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T, Rivacor 3 DR-T (P000009/S107) | Biotronik, Inc. | 2024-05-09 |
| 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 D (P980023/S124) | Biotronik, Inc. | 2024-05-09 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf (P100021/S121) | Medtronic Vascular | 2024-05-08 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S033) | Biotronik AG | 2024-05-08 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S029) | Medtronic Vascular, Inc. | 2024-05-08 |
| Resolute Onyx Rapid Exchange Zotarolimus Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolim (P160043/S081) | Medtronic Vascular | 2024-05-08 |
| Harmony Delivery Catheter System (P200046/S033) | Medtronic, Inc. | 2024-05-08 |
| VenaSeal Closure System (P140018/S042) | Medtronic Vascular, Inc. | 2024-05-08 |
| Micra TPS, Micra VR TPS, Micra AV TPS (P150033/S188) | Medtronic, Inc. | 2024-05-08 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (P140010/S080) | Medtronic, Inc. | 2024-05-08 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S030) | Boston Scientific Corporation | 2024-05-08 |
| Symplicity Spyral' Multi-Electrode Renal Denervation Catheter (P220026/S007) | Medtronic, Inc. | 2024-05-08 |
| Valiant Thoracic Stent Graft System (FreeFlo Tapers Line Extention) with Captivia Delivery System, Valiant Thoracic Sten (P100040/S063) | Medtronic Vascular | 2024-05-08 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Sys (P130021/S163) | Medtronic, Inc. | 2024-05-08 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S537) | Medtronic, Inc. | 2024-05-07 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt (P130021/S162) | Medtronic, Inc. | 2024-05-07 |
| Advisa DR IPG, Advisa DR MRl IPG, Advisa SR MRl IPG, Astra S DR MRl IPG, Astra S SR MRl IPG, Astra XT DR MRl IPG, Astra (P980035/S780) | Medtronic, Inc. | 2024-05-07 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S046) | Medtronic Vascular, Inc. | 2024-05-03 |
| LifeVest Wearable Defibrillator Model 5100 (P010030/S176) | Zoll Manufacturing Corporation | 2024-05-03 |
| TREO® Abdominal Stent-Graft System (P190015/S018) | Bolton Medical, Inc. | 2024-05-03 |
| FARAPULSE Pulsed Field Ablation System (P230030/S004) | Farapulse, Inc. | 2024-05-03 |
| EverFlex Self-Expanding Peripheral Stent System, 2 EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Sys (P110023/S045) | Medtronic Vascular, Inc. | 2024-05-02 |
| Artegraft Collagen Vascular Graft (N16837/S033) | LeMaitre Vascular, Inc. | 2024-05-02 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 (P950037/S256) | Biotronik, Inc. | 2024-05-02 |
| HeartMate 3 Left Ventricular Assist System (P160054/S078) | ABBOTT MEDICAL | 2024-05-02 |
| DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S042) | Cardiovascular Systems, Inc. | 2024-05-02 |
| Epsila EV Extravascular Lead (P220012/S024) | Medtronic, Inc. | 2024-05-02 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S002) | Medtronic, Inc. | 2024-05-01 |
| Avant, Gallant, Entrant, Neutrino NxT Family of ICDs (P910023/S464) | ABBOTT MEDICAL | 2024-05-01 |
| Avant, Gallant, Entrant, Neutrino NxT Family of CRT-Ds (P030054/S419) | ABBOTT MEDICAL | 2024-05-01 |
| Assurity MRI, Endurity MRI, Zenus MRI and Zenex MRI Family of Pacemakers (P140033/S088) | ABBOTT MEDICAL | 2024-05-01 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP family of CRT-Ps (P030035/S201) | ABBOTT MEDICAL | 2024-05-01 |
| Aveir VR Delivery Catheter and Aveir DR Delivery Catheter (P150035/S010) | ABBOTT MEDICAL | 2024-05-01 |
| CentriMag Circulatory Support System (P170038/S016) | Abbott | 2024-05-01 |
| Assurity, Assurity+, Endurity, Endurity Core, Zenus, Zenex Family of Pacemakers (P880086/S336) | ABBOTT MEDICAL | 2024-05-01 |
| LATITUDE Programming System (P910077/S193) | Boston Scientific | 2024-04-30 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S499) | Boston Scientific | 2024-04-30 |
| INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S236) | Guidant Corp. | 2024-04-30 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P010012/S580) | Boston Scientific Corp | 2024-04-30 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S291) | Boston Scientific Corp | 2024-04-30 |
| EMBLEM S-ICD (P110042/S193) | Boston Scientific Corporation | 2024-04-30 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S155) | Boston Scientific | 2024-04-30 |
| LIFEPAK® 35 Monitor/Defibrillator (P160026/S047) | Physio-Control, Inc. | 2024-04-29 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S011) | Cook Medical Incorporated | 2024-04-29 |
| GORE® CARDIOFORM ASD Occluder, GORE® CARDIOFORM Septal Occluder (P050006/S109) | W. L. Gore & Associates, Inc. | 2024-04-29 |
| Zenith Dissection Endovascular System (P180001/S012) | William Cook Europe Aps | 2024-04-29 |
| HeartWare HVAD System (P100047/S215) | Medtronic | 2024-04-29 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| LIFEPAK® 35 Monitor/Defibrillator (P160026/S048) | Physio-Control, Inc. | 2024-04-29 |
| Vascular Closure System (VCS) (P120016/S036) | Cardiva Medical, Inc. | 2024-04-26 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036) | ABBOTT MEDICAL | 2024-04-26 |
| Cobalt XT MRI ICD (P980016/S890) | Medtronic Cardiac Rhythm Disease Management | 2024-04-26 |
| CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D (P010031/S856) | Medtronic Cardiac Rhythm Disease Management | 2024-04-26 |
| Heart Failure Risk Status (HFRS), Triage-HF (P890003/S466) | Medtronic, Inc. | 2024-04-26 |
| 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/S855) | Medtronic Cardiac Rhythm Disease Management | 2024-04-25 |
| TherOx Downstream System (P170027/S013) | Zoll Circulation, Inc. | 2024-04-25 |
| Aurora EV-ICD (P220012/S021) | Medtronic, Inc. | 2024-04-25 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera X (P980016/S889) | Medtronic Cardiac Rhythm Disease Management | 2024-04-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S536) | Medtronic, Inc. | 2024-04-25 |
| CentriMag Circulatory Support System (P170038/S015) | Abbott | 2024-04-24 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S003) | Edwards Lifesciences, LLC | 2024-04-24 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S020) | Biotronik AG | 2024-04-24 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S037) | Biotronik AG | 2024-04-24 |
| Aurora EV-ICD System (P220012/S020) | Medtronic, Inc. | 2024-04-24 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage (P130013/S068) | Boston Scientific Corp | 2024-04-24 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon (P190008/S028) | Medtronic Vascular, Inc. | 2024-04-23 |
| LIFEPAK® CR2 defibrillator (P170018/S019) | Physio-Control, Inc. | 2024-04-23 |
| Mosaic Bioprosthesis (P990064/S088) | Medtronic, Inc. | 2024-04-22 |
| CentriMag Circulatory Support System (P170038/S014) | Abbott | 2024-04-22 |
| Avalus Bioprosthesis and Avalus Ultra Bioprosthesis (P170006/S033) | Medtronic, Inc. | 2024-04-22 |
| Freestyle Bioprosthesis (P970031/S073) | Medtronic, Inc. | 2024-04-22 |
| Hancock Valved Conduit (P870078/S051) | Medtronic, Inc. | 2024-04-22 |
| Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (P170006/S034) | Medtronic, Inc. | 2024-04-22 |
| Hancock II Bioprosthesis (P980043/S079) | Medtronic, Inc. | 2024-04-22 |
| Hancock Modified Orifice Valved Conduit (P790007/S066) | Medtronic Heart Valves | 2024-04-22 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S109) | Biotronik, Inc. | 2024-04-19 |
| LimFlow System (P220025/S003) | LimFlow, Inc. | 2024-04-19 |
| BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si (P180050/S011) | Cvrx, Inc. | 2024-04-19 |