| P980035S846 | Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED | Medtronic, Inc. | 2026-07-31 |
| P980035S845 | Adapta, Versa, Sensia IPG (ADDR06, ADDRS1, ADSR01, ADSR03, ADSR06, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); | Medtronic, Inc. | 2026-07-31 |
| P980035S844 | Adapta, Versa, Sensia IPG (ADDR03, ADDR06, ADSR01, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); Adapta, Versa, S | Medtronic, Inc. | 2026-07-31 |
| P980016S963 | Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR | Medtronic Cardiac Rhythm Disease Management | 2026-07-31 |
| P980016S962 | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I | Medtronic Cardiac Rhythm Disease Management | 2026-07-31 |
| P980016S961 | Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I | Medtronic Cardiac Rhythm Disease Management | 2026-07-31 |
| P890003S487 | CareLink SmartSync Device Manager Base (24970A) | Medtronic, Inc. | 2026-07-31 |
| P250016S002 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | 2026-07-31 |
| P240014S001 | MAGiC Ablation Catheter | Stereotaxis, Inc. | 2026-07-31 |
| P220012S075 | Aurora EV-ICD (DVEA3E4) | Medtronic, Inc. | 2026-07-31 |
| P220012S074 | Aurora EV ICD (DVEA3E4) | Medtronic, Inc. | 2026-07-31 |
| P200041S005 | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-07-31 |
| P190016S012 | Tula® System | Tusker Medical, Inc. | 2026-07-31 |
| P160036S008 | Hintermann Series H3 Total Ankle Replacement System | Dt Medtech, LLC | 2026-07-31 |
| P150033S229 | Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) | Medtronic, Inc. | 2026-07-31 |
| P150033S228 | Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) | Medtronic, Inc. | 2026-07-31 |
| P110019S142 | XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent Systems | Abbott Vascular | 2026-07-31 |
| P100044S059 | Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants | Intersect Ent. | 2026-07-31 |
| P010031S930 | Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4) Brava Quad | Medtronic Cardiac Rhythm Disease Management | 2026-07-31 |
| P010031S929 | Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR | Medtronic Cardiac Rhythm Disease Management | 2026-07-31 |
| P010031S928 | Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4);Brava Quad | Medtronic Cardiac Rhythm Disease Management | 2026-07-31 |
| P010015S589 | Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar | Medtronic, Inc. | 2026-07-31 |
| P010015S588 | Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T | Medtronic, Inc. | 2026-07-31 |
| P250036 | PGDx elio tissue complete CDx | Personal Genome Diagnostics, Inc. | 2026-07-30 |
| P240024S004 | Genio® System 2.1 | Nyxoah S.A. | 2026-07-30 |
| P230035S009 | AGENT™ Paclitaxel-Coated Balloon Catheter | Boston Scientific Corporation | 2026-07-30 |
| P170018S025 | LIFEPAK® CR2 Defibrillator | Physio-Control, Inc. | 2026-07-30 |
| P160054S130 | HeartMate 3™ Left Ventricular Assist System (LVAS) | ABBOTT MEDICAL | 2026-07-30 |
| P160026S070 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE | Physio-Control, Inc. | 2026-07-30 |
| P010030S202 | LifeVest® Wearable Defibrillator | Zoll Manufacturing Corporation | 2026-07-30 |
| P860057S227 | Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis Model 2800; Carpentier-Edwards PERIMOUNT RSR Pericardi | Edwards Lifesciences, LLC | 2026-07-29 |
| P250019S006 | Edwards SAPIEN M3 Dock (988DDS); Edwards 23F Guide Sheath (9880GS); Edwards SAPIEN M3 Crimper (9880CR); Edwards Commande | Edwards Lifesciences, LLC | 2026-07-29 |
| P240009S012 | Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | 2026-07-29 |
| P230013S031 | EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK) | Edwards Lifesciences, LLC | 2026-07-29 |
| P220023S012 | Paradise™ Ultrasound Renal Denervation System (Paradise System); Paradise™ Catheter | Recor Medical, Inc. | 2026-07-29 |
| P220003S031 | PASCAL Precision implant system (20000IS and 20000ISM); PASCAL Precision guide sheath system (20000GS) | Edwards Lifesciences, LLC | 2026-07-29 |
| P200030S026 | GORE® EXCLUDER® Conformable AAA Endoprosthesis | W. L. Gore and Associates, Inc. | 2026-07-29 |
| P200015S081 | Edwards SAPIEN 3 Pulmonic Delivery System (9630PL29); Edwards Alterra Adaptive Prestent System (29AP4045) | Edwards Lifesciences, LLC | 2026-07-29 |
| P150048S103 | EINSPIRIS RESILIA Aortic Valve, Model 11500A; KONECT RESILIA Aortic Valved Conduit (AVC), Model 11060A | Edwards Lifesciences, LLC | 2026-07-29 |
| P150036S080 | EDWARDS INTUITY Elite Valve, Model 8300AB | Edwards Lifesciences, LLC | 2026-07-29 |