| Embrace(TM) Hydrogel Embolic System (P250003/S001) | Instylla, Inc. | 2025-11-25 |
| ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P130010/S002) | MicroPort CRM USA, Inc. | 2025-11-25 |
| CorPASS System (P230040/S024) | Endotronix, Inc. | 2025-11-25 |
| ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P060027/S106) | MicroPort CRM USA, Inc. | 2025-11-25 |
| Micra Transcatheter Pacing Systems (P150033/S217) | Medtronic, Inc. | 2025-11-25 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S027) | The Spectranetics Corp. | 2025-11-24 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048) | W. L. Gore & Associates, Inc. | 2025-11-24 |
| Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack (P200032/S003) | Occlutech Holding AG | 2025-11-24 |
| LIFEPAK® 35 monitor/defibrillator (P160026/S064) | Physio-Control, Inc. | 2025-11-21 |
| Durata Defibrillation Leads (P950022/S150) | ABBOTT MEDICAL | 2025-11-20 |
| Sphere-9 TM Mapping and Ablation Catheter (P240013/S018) | Medtronic, Inc. | 2025-11-20 |
| OptiSense Pacing Leads (P960013/S131) | ABBOTT MEDICAL | 2025-11-20 |
| Quartet and QuickFlex µ Left Heart Leads (P030054/S439) | ABBOTT MEDICAL | 2025-11-20 |
| IsoFlex Pacing Leads (P960030/S083) | ABBOTT MEDICAL | 2025-11-20 |
| Tendril MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers (P140033/S100) | ABBOTT MEDICAL | 2025-11-20 |
| OPTIMIZER SMART Mini IPG (P180036/S034) | Impulse Dynamics (Usa), Inc. | 2025-11-19 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (P230022/S004) | Element Science, Inc. | 2025-11-19 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S019) | Edwards Lifesciences, LLC | 2025-11-19 |
| Total Artificial Heart (P030011/S093) | Syncardia Systems, LLC | 2025-11-19 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (P230022/S002) | Element Science, Inc. | 2025-11-18 |
| Duo Venous Stent System (P230021/S002) | Philips Image Guided Therapy Corporation | 2025-11-18 |
| EPi-Sense ST Coagulation System (P200002/S013) | AtriCure, Inc. | 2025-11-14 |
| HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (P200007/S001) | Graphic Controls D.B.A. Vermed | 2025-11-12 |
| CardioMEMS HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) (P100045/S087) | ABBOTT MEDICAL | 2025-11-10 |
| Mosaic Bioprosthesis (P990064/S093) | Medtronic, Inc. | 2025-11-10 |
| Freestyle Bioprosthesis (P970031/S076) | Medtronic, Inc. | 2025-11-10 |
| Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (P170006/S038) | Medtronic, Inc. | 2025-11-10 |
| Hancock II Bioprosthesis (P980043/S084) | Medtronic, Inc. | 2025-11-10 |
| Protégé GPS self-expanding Peripheral Stent System (P060001/S052) | Medtronic Vascular, Inc. | 2025-11-07 |
| EverFlex self-expanding Peripheral Stent System (EverFlex) (P110023/S061) | Medtronic Vascular, Inc. | 2025-11-07 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D (P130013/S081) | Boston Scientific Corp | 2025-11-06 |
| LIFEPAK® CR2 Automated External Defibrillator (P170018/S023) | Physio-Control, Inc. | 2025-11-06 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S112) | ABBOTT MEDICAL | 2025-11-04 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S013) | Edwards Lifesciences, LLC | 2025-10-31 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S023) | ABBOTT MEDICAL | 2025-10-30 |
| OmniaSecure MRI SureScan Lead Model 3930M (P240036/S003) | Medtronic, Inc. | 2025-10-30 |
| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S481) | Medtronic, Inc. | 2025-10-30 |
| Epic, Epic Supra, Epic Plus, Epic Plus Supra and Epic Max Stented Tissue Valve (P040021/S060) | ABBOTT MEDICAL | 2025-10-30 |
| Avalus Bioprosthesis (P170006/S041) | Medtronic, Inc. | 2025-10-30 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S009) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-10-29 |
| TherOx Downstream System (P170027/S020) | Zoll Circulation, Inc. | 2025-10-29 |
| Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira SD 65/18 4 (P980023/S141) | Biotronik, Inc. | 2025-10-29 |
| SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110) | Boston Scientific Corporation | 2025-10-29 |
| OmniaSecure MRI SureScan Lead Model 3930M (P240036/S002) | Medtronic, Inc. | 2025-10-29 |
| Thoraflex Hybrid (P210006/S015) | Vascutek, Ltd. | 2025-10-29 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S906) | Medtronic Cardiac Rhythm Disease Management | 2025-10-28 |
| Aurora EV ICD (DVEA3E4) (P220012/S059) | Medtronic, Inc. | 2025-10-28 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S033) | Corcym S.r.l. | 2025-10-28 |
| Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (P980016/S939) | Medtronic Cardiac Rhythm Disease Management | 2025-10-28 |
| Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle) (P150035/S033) | ABBOTT MEDICAL | 2025-10-28 |
| DBP-1400-ABE and DBP-2003- ABE (P190013/S001) | Aed Battery Exchange, LLC | 2025-10-28 |
| Perceval Sutureless Heart Valve (P150011/S034) | Corcym S.r.l. | 2025-10-28 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099) | W. L. Gore & Associates, Inc. | 2025-10-27 |
| ROTAPRO Rotational Atherectomy System (P900056/S222) | Boston Scientific Corp | 2025-10-27 |
| TRIFORMIS RESILIA Tricuspid Valve (P150048/S092) | Edwards Lifesciences, LLC | 2025-10-27 |
| Innova Vascular Self-Expanding Stent System (P140028/S084) | Boston Scientific Corporation | 2025-10-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S039) | Boston Scientific Corporation | 2025-10-24 |
| 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/S196) | Biotronik, Inc. | 2025-10-24 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S067) | Boston Scientific Corp | 2025-10-24 |
| 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/S167) | Biotronik, Inc. | 2025-10-24 |
| FINELINE II Leads (P960004/S109) | Boston Scientific | 2025-10-24 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S007) | Boston Scientific Corporation | 2025-10-24 |
| ACUITY X4 Leads (P010012/S593) | Boston Scientific Corp | 2025-10-24 |
| ENDOTAK RELIANCE Leads (P910073/S182) | Boston Scientific | 2025-10-24 |
| 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/S272) | Biotronik, Inc. | 2025-10-24 |
| Amplatzer Duct Occluder; Amplatzer Duct Occluder II; Amplatzer Piccolo Occluder (P020024/S071) | ABBOTT MEDICAL | 2025-10-23 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| Harmony Transcatheter Pulmonary Valve (P200046/S044) | Medtronic, Inc. | 2025-10-23 |
| Melody Transcatheter Pulmonary Valve (P140017/S032) | Medtronic, Inc. | 2025-10-23 |
| Amplatzer Muscular VSD Occluder (P040040/S050) | ABBOTT MEDICAL | 2025-10-23 |
| Mosaic Bioprosthesis, Models 305, 310 (P990064/S095) | Medtronic, Inc. | 2025-10-23 |
| Hancock II Bioprosthesis, Models T505, T510 (P980043/S085) | Medtronic, Inc. | 2025-10-23 |
| Amplatzer PFO Occluder; Amplatzer Talisman PFO Occluder (P120021/S027) | ABBOTT MEDICAL | 2025-10-23 |
| ENROUTE® Transcarotid Stent System (P140026/S032) | Boston Scientific Corporation | 2025-10-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S013) | ABBOTT MEDICAL | 2025-10-23 |
| Avalus Bioprosthesis, Model 400 (P170006/S039) | Medtronic, Inc. | 2025-10-23 |
| Freestyle Bioprosthesis, Models 995, 995CS, 995MS (P970031/S077) | Medtronic, Inc. | 2025-10-23 |
| Amplatzer Septal Occluder; Amplatzer Multi-Fenestrated Septal Occluder - Cribriform (P000039/S083) | ABBOTT MEDICAL | 2025-10-23 |
| Organ Care System (OCS) Heart System (P180051/S008) | TransMedics, Inc. | 2025-10-22 |
| U125 VALITUDE CRT-P,U128 VALITUDE X4 CRT-P,U225 VISIONIST CRT-P,U226 VISIONIST CRT-P,U228 VISIONIST X4 CRT-P (P030005/S249) | Guidant Corp. | 2025-10-22 |
| RX Herculink Elite (P110001/S022) | Abbott Vascular | 2025-10-22 |
| RX Acculink (P040012/S066) | Abbott Vascular | 2025-10-22 |
| On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (AAP) (P000037/S066) | On-X Life Technologies, Inc. | 2025-10-22 |
| L110 ESSENTIO MRI SR,L111 ESSENTIO MRI DR,L131 ESSENTIO MRI EL DR,L210 PROPONENT,L211 PROPONENT,L231 PROPONENT,L310 A (P150012/S172) | Boston Scientific | 2025-10-22 |
| D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI (P960040/S510) | Boston Scientific | 2025-10-22 |
| D010 INOGEN MINI ICD VR,D011 INOGEN MINI ICD VR,D012 INOGEN MINI ICD DR,D013 INOGEN MINI ICD DR,D020 DYNAGEN MINI I (P960040/S511) | Boston Scientific | 2025-10-22 |
| Absolute Pro Vascular (P110028/S025) | Abbott Vascular, Inc. | 2025-10-22 |
| On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis (P000037/S064) | On-X Life Technologies, Inc. | 2025-10-22 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S023) | Endotronix, Inc. | 2025-10-22 |
| On-X Heart Valve; On-X Ascending Aortic Prosthesis (P000037/S063) | On-X Life Technologies, Inc. | 2025-10-22 |
| Medtronic Evolut PRO+ Delivery Catheter System (P130021/S178) | Medtronic, Inc. | 2025-10-22 |
| Zilver Flex® 35 Vascular Stent (P050017/S025) | Cook Ireland, Ltd. | 2025-10-22 |
| G124 MOMENTUM CRT-D,G125 MOMENTUM CRT-D,G126 MOMENTUM CRT-D,G128 MOMENTUM,G138 MOMENTUM X4 CRT-D,G140 INOGEN CRT-D, (P010012/S599) | Boston Scientific Corp | 2025-10-22 |
| LimFlow System (P220025/S007) | LimFlow, Inc. | 2025-10-22 |
| On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (P000037/S065) | On-X Life Technologies, Inc. | 2025-10-22 |
| A209 SICD Gen 2,A219 SICD MRI (P110042/S206) | Boston Scientific Corporation | 2025-10-22 |
| G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN C (P010012/S598) | Boston Scientific Corp | 2025-10-22 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) (P110019/S137) | Abbott Vascular | 2025-10-22 |
| L100 ESSENTIO SR,L101 ESSENTIO DR,L121 ESSENTIO EL DR,L200 PROPONENT SR,L201 PROPONENT DR,L221 PROPONENT EL DR,L30 (N970003/S303) | Boston Scientific Corp | 2025-10-22 |
| Esprit BTK RX System; Esprit BTK OTW System (P230036/S016) | ABBOTT MEDICAL | 2025-10-22 |