| Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S094) | ABBOTT MEDICAL | 2024-10-28 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, Avant, Neutrino NxT, Gallant, Entrant (P030054/S427) | ABBOTT MEDICAL | 2024-10-28 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP, Anthem (P030035/S206) | ABBOTT MEDICAL | 2024-10-28 |
| Avant, Neutrino NxT, Gallant, Entrant, Fortify VR, Fortify DR, Ellipse VR, Ellipse DR, Fortify Assura VR, Fortify A (P910023/S472) | ABBOTT MEDICAL | 2024-10-28 |
| Defibrillator, Implantable, Dual-Chamber (P000009/S115) | Biotronik, Inc. | 2024-10-25 |
| Implantable Cardioverter Defibrillator (Non- Crt) (P980023/S131) | Biotronik, Inc. | 2024-10-25 |
| 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/S160) | Biotronik, Inc. | 2024-10-25 |
| Paradise® Ultrasound Renal Denervation System (P220023/S003) | Recor Medical, Inc. | 2024-10-25 |
| Pulse Generator, Permanent, Implantable (P950037/S264) | Biotronik, Inc. | 2024-10-25 |
| 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/S793) | Medtronic, Inc. | 2024-10-25 |
| PRECISE PRO Rx Nitinol Stent System (P030047/S048) | Cordis US Corporation | 2024-10-25 |
| Implantable Cardioverter Defibrillator (Non- Crt), Defibrillator, Implantable, Dual-Chamber, Defibrillator, Automatic Im (P050023/S188) | Biotronik, Inc. | 2024-10-25 |
| ENROUTE® Transcarotid Stent System (P140026/S030) | Boston Scientific Corporation | 2024-10-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S546) | Medtronic, Inc. | 2024-10-25 |
| The S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System (P120002/S027) | Cordis US Corporation | 2024-10-25 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S161) | Biotronik, Inc. | 2024-10-25 |
| S.M.A.R.T. CONTROL Vascular Stent System, S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S052) | Cordis US Corporation | 2024-10-25 |
| FARAWAVE Pulsed Field Ablation Catheter (P230030/S006) | Farapulse, Inc. | 2024-10-24 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S134) | Abbott Vascular | 2024-10-24 |
| Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter (P200039/S013) | Shockwave Medical, Inc. | 2024-10-24 |
| Sphere-9 Catheter and Affera Ablation System (P240013) | Medtronic, Inc. | 2024-10-24 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S242) | Guidant Corp. | 2024-10-23 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S161) | Boston Scientific | 2024-10-23 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S296) | Boston Scientific Corp | 2024-10-23 |
| Organ Care System (OCS) Heart System (P180051/S007) | TransMedics, Inc. | 2024-10-23 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S199) | Boston Scientific Corporation | 2024-10-23 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S586) | Boston Scientific Corp | 2024-10-23 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S502) | Boston Scientific | 2024-10-23 |
| OPTIMIZER Smart System (P180036/S035) | Impulse Dynamics (Usa), Inc. | 2024-10-23 |
| MitraClip G4 Clip Delivery System (P100009/S068) | ABBOTT MEDICAL | 2024-10-22 |
| Navitor Titan Valve (P190023/S023) | ABBOTT MEDICAL | 2024-10-22 |
| TriClip G4 Clip Delivery System (P230007/S006) | ABBOTT MEDICAL | 2024-10-22 |
| Solia S 45, Solia S 53, Solia S 60, Solia JT 45, Solia JT 53, Solia T 53, Solia T 60 (P950037/S265) | Biotronik, Inc. | 2024-10-21 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S085) | Medtronic, Inc. | 2024-10-21 |
| Impella 5.5 with SmartAssist (P140003/S119) | Abiomed, Inc. | 2024-10-21 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S034) | Medtronic Vascular, Inc. | 2024-10-21 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S061) | Boston Scientific Corp | 2024-10-18 |
| SMARTFREEZETM Catheter Extension Cable (P220032/S004) | Boston Scientific Corporation | 2024-10-18 |
| Abre Venous Self-expanding Stent System (P200026/S012) | Medtronic Vascular, Inc. | 2024-10-18 |
| FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation Catheter, FARASTAR Pulsed Field Ablation (P230030/S003) | Farapulse, Inc. | 2024-10-18 |
| LifeVest Wearable Defibrillator (P010030/S187) | Zoll Manufacturing Corporation | 2024-10-18 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S044) | Biotronik AG | 2024-10-17 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S547) | Medtronic, Inc. | 2024-10-17 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S264) | Medtronic, Inc. | 2024-10-17 |
| Aurora EV ICD, Epsila EV Extravascular Lead (P220012/S032) | Medtronic, Inc. | 2024-10-17 |
| Aveir VR Delivery Catheter (P150035/S018) | ABBOTT MEDICAL | 2024-10-17 |
| Myocardial Pacing Lead (P120017/S036) | Medtronic, Inc. | 2024-10-17 |
| Perceval Plus Sutureless Heart Valve (P150011/S029) | Corcym S.r.l. | 2024-10-17 |
| Micra TPS, Micra VR TPS (P150033/S192) | Medtronic, Inc. | 2024-10-17 |
| Transvene CS/SVC Lead (P980050/S143) | Medtronic, Inc. | 2024-10-17 |
| 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/S794) | Medtronic, Inc. | 2024-10-17 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S225) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| SelectSecure Lead (P030036/S149) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S113) | W. L. Gore & Associates, Inc. | 2024-10-17 |
| 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/S869) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| CapSure Epicardial Pacing Lead (P950024/S112) | Medtronic, Inc. | 2024-10-17 |
| Epicardial Patch Lead, Upsizing Sleeve (P900061/S173) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| Artegraft Collagen Vascular Graft (N16837/S034) | LeMaitre Vascular, Inc. | 2024-10-17 |
| LIFEPAK CR2 Defibrillator (P170018/S021) | Physio-Control, Inc. | 2024-10-17 |
| Attain StarFix Lead (P060039/S116) | Medtronic, Inc. | 2024-10-17 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S186) | Medtronic, Inc. | 2024-10-17 |
| CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead (P850089/S169) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| NIT-OCCLUD PDA (P120009/S004) | Pfm Medical, Inc. | 2024-10-17 |
| DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead. Subcutaneous Lead, Transvene C (P920015/S293) | Medtronic, Inc. | 2024-10-17 |
| 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/S903) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| Epic Plus, Epic Max Tissue Heart Valves (P040021/S054) | ABBOTT MEDICAL | 2024-10-17 |
| AED Plus and Fully Automatic AED Plus (P160015/S017) | ZOLL Medical Corporation | 2024-10-16 |
| Safire TX Ablation Catheter, Safire TX, Catheter Extension Cable, Therapy Dual-8 Ablation Catheter, Cables 16- 17- 1 (P040042/S056) | Irvine Biomedical,Inc.(Ibi) | 2024-10-15 |
| Therapy Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19- (P040014/S049) | Irvine Biomedical, Inc. | 2024-10-15 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S045) | Biotronik AG | 2024-10-15 |
| Organ Care System (OCS) Heart (P180051/S006) | TransMedics, Inc. | 2024-10-11 |
| Merlin.net MN5000 (P880086/S334) | ABBOTT MEDICAL | 2024-10-11 |
| DETOUR System (P220021/S003) | Endologix, LLC | 2024-10-11 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S141) | W. L. Gore & Associates, Inc. | 2024-10-11 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S017) | W. L. Gore & Associates, Inc. | 2024-10-11 |
| Solia S Leads (P950037/S261) | Biotronik, Inc. | 2024-10-11 |
| Merlin.net MN5000 (P140033/S086) | ABBOTT MEDICAL | 2024-10-11 |
| Merlin.net MN5000 (P030054/S418) | ABBOTT MEDICAL | 2024-10-11 |
| AVEIR Patient Transmitter, AVEIR Patient Transmitter Software, AVEIR Patient Trasmitter Wired Electrodes, Merlin.net (P150035/S007) | ABBOTT MEDICAL | 2024-10-11 |
| Merlin.net MN5000 (P910023/S463) | ABBOTT MEDICAL | 2024-10-11 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (P240009) | Contego Medical, Inc. | 2024-10-11 |
| Merlin.net MN5000 (P030035/S199) | ABBOTT MEDICAL | 2024-10-11 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S068) | Medtronic Vascular | 2024-10-10 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S004) | Endotronix, Inc. | 2024-10-10 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S124) | Medtronic Vascular | 2024-10-10 |
| PK-175/2,3m Patient Cable, PK-83, 2.5m (P950037/S263) | Biotronik, Inc. | 2024-10-09 |
| samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr (P160008/S026) | Heartsine Technologies, Ltd. | 2024-10-09 |
| GORE CARDIOFORM ASD Occluder (P050006/S112) | W. L. Gore & Associates, Inc. | 2024-10-09 |
| MynxGrip Vascular Closure Device (5F, 6F/7F) (P040044/S104) | Cordis US Corporation | 2024-10-09 |
| TactiCath Contact Force Ablation Catheter (P130026/S090) | St Jude Medical | 2024-10-09 |
| TW Torque wrench (P980023/S130) | Biotronik, Inc. | 2024-10-09 |
| TactiFlex Ablation Catheter, Sensor Enabled, TactiCath Contact Force Ablation Catheter, Sensor Enabled (P220013/S013) | ABBOTT MEDICAL | 2024-10-09 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S014) | Kestra Medical Technologies, Inc. | 2024-10-08 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S001) | Endotronix, Inc. | 2024-10-04 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S005) | Endotronix, Inc. | 2024-10-03 |
| Ellipse DR, Ellipse VR (P910023/S471) | ABBOTT MEDICAL | 2024-10-03 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE) (P210032/S016) | W. L. Gore & Associates, Inc. | 2024-10-03 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S004) | Edwards Lifesciences, LLC | 2024-10-03 |
| TherOx Downstream System (P170027/S014) | Zoll Circulation, Inc. | 2024-10-03 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S168) | Medtronic Cardiac Rhythm Disease Management | 2024-10-01 |