| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S472) | Medtronic, Inc. | 2024-10-01 |
| Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder (P120021/S025) | ABBOTT MEDICAL | 2024-10-01 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S007) | ABBOTT MEDICAL | 2024-10-01 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S224) | Medtronic Cardiac Rhythm Disease Management | 2024-10-01 |
| SelectSecure Lead (P030036/S148) | Medtronic Cardiac Rhythm Disease Management | 2024-10-01 |
| IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead (P920015/S292) | Medtronic, Inc. | 2024-10-01 |
| Amplatzer Septal Occluder, Amplatzer Multifenestrated Septal Occluder Cribriform (P000039/S079) | ABBOTT MEDICAL | 2024-10-01 |
| SYNERGY SHIELD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System, YNERGY MEGATRON Monorail Everolimu (P150003/S102) | Boston Scientific Corporation | 2024-10-01 |
| Amplatzer Muscular VSD Occluder (P040040/S047) | ABBOTT MEDICAL | 2024-10-01 |
| LIFEPAK® CR2 Defibrillator (P170018/S020) | Physio-Control, Inc. | 2024-10-01 |
| CapSure Epicardial Pacing Lead (P950024/S111) | Medtronic, Inc. | 2024-10-01 |
| FlexNav and Navitor Loading System, FlexNav Delivery System (P190023/S020) | ABBOTT MEDICAL | 2024-10-01 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S069) | ABBOTT MEDICAL | 2024-10-01 |
| Navitor Transcatheter Aortic Heart Valves (P190023/S022) | ABBOTT MEDICAL | 2024-09-30 |
| 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/S791) | Medtronic, Inc. | 2024-09-30 |
| 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/S892) | Medtronic Cardiac Rhythm Disease Management | 2024-09-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S083) | ABBOTT MEDICAL | 2024-09-27 |
| Aurora EV-ICD (P220012/S025) | Medtronic, Inc. | 2024-09-27 |
| Amolia MRI CRT-D, Amolia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S858) | Medtronic Cardiac Rhythm Disease Management | 2024-09-27 |
| Alto Abdominal Stent Graft System (P120006/S044) | Endologix, LLC | 2024-09-27 |
| AFX2 Endovascular AAA System (P040002/S075) | Endologix, LLC | 2024-09-27 |
| Evolut FX Delivery Catheter System of the Medtronic Evolut FX System (P130021/S168) | Medtronic, Inc. | 2024-09-27 |
| IsoFlex (P960030/S078) | ABBOTT MEDICAL | 2024-09-26 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Relia IPG (P980035/S792) | Medtronic, Inc. | 2024-09-26 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S219) | Medtronic | 2024-09-26 |
| Novoste Beta-Cath System (P000018/S051) | Best Vascular, Inc. | 2024-09-26 |
| Quartet (P030054/S424) | ABBOTT MEDICAL | 2024-09-26 |
| Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, Endurant IIs Stent Graft System, E (P100021/S123) | Medtronic Vascular | 2024-09-26 |
| RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S084) | Medtronic Vascular | 2024-09-26 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S046) | Biotronik AG | 2024-09-26 |
| Aveir VR Leadless Pacemaker: AveirLeadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker: Aveir Leadless (P150035/S014) | ABBOTT MEDICAL | 2024-09-26 |
| Quadra Allure, Quadra Allure MP (P030035/S203) | ABBOTT MEDICAL | 2024-09-26 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S066) | Medtronic Vascular | 2024-09-26 |
| Tendril STS, UltiPace (P960013/S126) | ABBOTT MEDICAL | 2024-09-26 |
| Aveir Leadless System (Dual-Chamber) (P880086/S337) | ABBOTT MEDICAL | 2024-09-25 |
| LIFEPAK® 1000 Defibrillator (P160026/S051) | Physio-Control, Inc. | 2024-09-25 |
| CentriMag Circulatory Support System (P170038/S020) | Abbott | 2024-09-25 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG) (P110042/S198) | Boston Scientific Corporation | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P030054/S423) | ABBOTT MEDICAL | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P140033/S091) | ABBOTT MEDICAL | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P910023/S468) | ABBOTT MEDICAL | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P030035/S202) | ABBOTT MEDICAL | 2024-09-25 |
| Zenith® Alpha Thoracic Endovascular Graft (P140016/S010) | Cook Medical Incorporated | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P150035/S013) | ABBOTT MEDICAL | 2024-09-25 |
| Lava Liquid Embolic System (Lava LES) (P220020/S003) | Sirtex Medical, Inc. | 2024-09-24 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S042) | Biotronik AG | 2024-09-24 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D (P130013/S070) | Boston Scientific Corp | 2024-09-23 |
| Avive Automated External Defibrillator (AED) System (P210015/S003) | Avive Solutions, Inc. | 2024-09-23 |
| HeartMate 3 Left Ventricular Assist System (P160054/S082) | ABBOTT MEDICAL | 2024-09-23 |
| Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6 (P980023/S129) | Biotronik, Inc. | 2024-09-21 |
| BioMimics 3D Vascular Stent System (P180003/S010) | Veryan Medical, Ltd. | 2024-09-20 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S133) | Abbott Vascular | 2024-09-20 |
| Omnilink Elite Vascular Balloon-Expandable Stent System (P110043/S014) | Abbott Vascular-Cardiac Therapies | 2024-09-20 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S025) | Heartsine Technologies, Ltd. | 2024-09-20 |
| HeartMate 3 Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P160054/S086) | ABBOTT MEDICAL | 2024-09-18 |
| 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/S789) | Medtronic, Inc. | 2024-09-18 |
| Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara (P010015/S544) | Medtronic, Inc. | 2024-09-18 |
| LifeVest® Wearable Defibrillator (P010030/S182) | Zoll Manufacturing Corporation | 2024-09-18 |
| HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P060040/S108) | ABBOTT MEDICAL | 2024-09-18 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S052) | Medtronic Vascular, Inc. | 2024-09-17 |
| INGEVITY + Leads - Active Fixation (P150012/S158) | Boston Scientific | 2024-09-16 |
| LIFEPAK 35 monitor/defibrillator (P160026/S052) | Physio-Control, Inc. | 2024-09-13 |
| MYNXGRIP Vascular Closure Device, MYNX CONTROL Vascular Closure Device (P040044/S103) | Cordis US Corporation | 2024-09-13 |
| 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/S900) | Medtronic Cardiac Rhythm Disease Management | 2024-09-12 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S082) | Edwards Lifesciences, LLC | 2024-09-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S058) | Edwards Lifesciences, LLC | 2024-09-12 |
| EDWARDS INTUITY Elite Valve System (P150036/S076) | Edwards Lifesciences, LLC | 2024-09-12 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRTD, Cobalt M (P010031/S866) | Medtronic Cardiac Rhythm Disease Management | 2024-09-12 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S118) | Abiomed, Inc. | 2024-09-12 |
| POLARx and POLARxFIT Cryoablation Catheters (P220032/S008) | Boston Scientific Corporation | 2024-09-12 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S097) | W. L. Gore & Associates, Inc. | 2024-09-12 |
| Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN (P860057/S219) | Edwards Lifesciences, LLC | 2024-09-12 |
| 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/S787) | Medtronic, Inc. | 2024-09-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S178) | Edwards Lifesciences, LLC | 2024-09-12 |
| Aurora EV-ICD (P220012/S030) | Medtronic, Inc. | 2024-09-12 |
| Edwards Commander Delivery System (P200015/S057) | Edwards Lifesciences, LLC | 2024-09-11 |
| HeartMate 3 Left Ventricular Assist System (P160054/S085) | ABBOTT MEDICAL | 2024-09-11 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S018) | Edwards Lifesciences, LLC | 2024-09-11 |
| Edwards Commander Delivery System (P140031/S177) | Edwards Lifesciences, LLC | 2024-09-11 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S019) | Edwards Lifesciences, LLC | 2024-09-11 |
| HeartMate II Left Ventricular Assist System (P060040/S107) | ABBOTT MEDICAL | 2024-09-11 |
| HeartStart FR3 Primary Battery (989803150161) (P160028/S005) | Philips Medical Systems, Inc. | 2024-09-11 |
| GORE® VIABAHN® Endoprosthesis (P040037/S166) | W. L. Gore & Associates, Inc. | 2024-09-10 |
| Protégé RX Carotid Stent System (P060001/S045) | Medtronic Vascular, Inc. | 2024-09-10 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S105) | W. L. Gore & Associates, Inc. | 2024-09-10 |
| Abre Venous Self-expanding Stent Systems Self-expanding Stent System (P200026/S011) | Medtronic Vascular, Inc. | 2024-09-10 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S051) | Medtronic Vascular, Inc. | 2024-09-09 |
| Defibtech Lifeline, Defibtech Lifeline AUTO, Defibtech Lifeline VIEW, Defibtech Lifeline VIEW AUTO, Defibtech Lifeline E (P160032/S011) | Defibtech, LLC | 2024-09-06 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S018) | W. L. Gore and Associates, Inc. | 2024-09-06 |
| PulseSelect PFA Loop Catheter (P230017/S003) | Medtronic, Inc. | 2024-09-06 |
| Spectranetics Laser Sheath (GlideLight/SLS) (P960042/S072) | Spectranetics (Philips) | 2024-09-05 |
| PALMAZ MULLINS XD Pulmonary Stent (P220004/S002) | Cordis US Corp | 2024-09-05 |
| ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) (P910001/S122) | Spectranetics Corp. | 2024-09-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S067) | Medtronic Vascular | 2024-09-05 |
| 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/S786) | Medtronic, Inc. | 2024-09-04 |
| Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo (P000009/S113) | Biotronik, Inc. | 2024-09-03 |
| 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/S186) | Biotronik, Inc. | 2024-09-03 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T (P980023/S128) | Biotronik, Inc. | 2024-09-03 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S013) | Kestra Medical Technologies, Inc. | 2024-09-03 |
| GUARDIO/VESTA Charger firmware (P180036/S031) | Impulse Dynamics (Usa), Inc. | 2024-08-30 |