| Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder (P120021/S026) | ABBOTT MEDICAL | 2024-12-13 |
| Amplatzer Septal Occluder, Amplatzer Multifenestrated Septal Occluder Cribriform (P000039/S080) | ABBOTT MEDICAL | 2024-12-13 |
| VenaSeal Closure System (P140018/S045) | Medtronic Vascular, Inc. | 2024-12-13 |
| GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder (P050006/S114) | W. L. Gore & Associates, Inc. | 2024-12-13 |
| Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S044) | Cardiovascular Systems, Inc. | 2024-12-12 |
| HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS (P160029/S026) | Philips Medical Systems, Inc. | 2024-12-12 |
| Symplicity Spyral Renal Denervation System (P220026/S010) | Medtronic, Inc. | 2024-12-11 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S007) | ABBOTT MEDICAL | 2024-12-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S034) | Boston Scientific Corporation | 2024-12-11 |
| Pulsar-18 T3 Stent System (P160025/S018) | Biotronik AG | 2024-12-11 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S041) | Biotronik AG | 2024-12-11 |
| TherOx DownStream System (P170027/S016) | Zoll Circulation, Inc. | 2024-12-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S031) | Boston Scientific Corporation | 2024-12-11 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S876) | Medtronic Cardiac Rhythm Disease Management | 2024-12-10 |
| Wolverine Coronary Cutting Balloon (Monorail) (P950020/S144) | Boston Scientific Corp | 2024-12-10 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S009) | ABBOTT MEDICAL | 2024-12-10 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S910) | Medtronic Cardiac Rhythm Disease Management | 2024-12-10 |
| CapSureFix Novus Lead (P930039/S266) | Medtronic, Inc. | 2024-12-09 |
| Cordella Pulmonary Artery Sensor System (P230040/S008) | Endotronix, Inc. | 2024-12-09 |
| Mynx Control Vascular Control Device, Mynx Control Venous Vascular Control Device (P040044/S108) | Cordis US Corporation | 2024-12-09 |
| Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP (P950037/S266) | Biotronik, Inc. | 2024-12-06 |
| Venovo Venous Stent System (P180037/S014) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| Enitra 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Enitra 8 HF-T QP, Evity 8 HF-T, Evity 8 HF-T QP (P070008/S162) | Biotronik, Inc. | 2024-12-06 |
| CardioMEMS HF System (P100045/S080) | ABBOTT MEDICAL | 2024-12-06 |
| Acticor 7 DR-T DF4 ProMRI, Rivacor 3 DR-T DF4 ProMRI, Rivacor 5 DR-T DF4 ProMRI, Rivacor 7 DR-T DF4 ProMRI, Acticor 7 HF (P050023/S189) | Biotronik, Inc. | 2024-12-06 |
| Intica Neo 5 DR-T DF-1 ProMRI, Ilivia Neo 7 DR-T DF-1 ProMRI, Intica Neo 7 DR-T DF-1 ProMRI (P000009/S116) | Biotronik, Inc. | 2024-12-06 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S013) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| Ilivia Neo 7 VR-T DF-1 ProMRI, Ilivia Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 5 VR-T DF-1 ProMRI, Intica Neo 5 VR-T DX DF- (P980023/S132) | Biotronik, Inc. | 2024-12-06 |
| NEO 2401.U/1 (P950037/S262) | Biotronik, Inc. | 2024-12-05 |
| NEO 2401.U/1 (P070008/S159) | Biotronik, Inc. | 2024-12-05 |
| Defibtech Lifeline, Defibtech Lifeline AUTO (P160032/S012) | Defibtech, LLC | 2024-12-05 |
| NEO 2401.U/1 (P000009/S114) | Biotronik, Inc. | 2024-12-05 |
| NEO 2401.U/1 (P050023/S187) | Biotronik, Inc. | 2024-12-05 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P200030/S016) | W. L. Gore and Associates, Inc. | 2024-12-04 |
| RELIANCE 4-FRONT (P910073/S179) | Boston Scientific | 2024-12-03 |
| HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P060040/S109) | ABBOTT MEDICAL | 2024-12-03 |
| IN.PACT AV DCB (P190008/S033) | Medtronic Vascular, Inc. | 2024-12-03 |
| HeartMate 3 Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P160054/S087) | ABBOTT MEDICAL | 2024-12-03 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S181) | Edwards Lifesciences, LLC | 2024-12-03 |
| IN.PACT Admiral DCB (P140010/S084) | Medtronic, Inc. | 2024-12-03 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve (P150048/S086) | Edwards Lifesciences, LLC | 2024-12-03 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S111) | Abiomed, Inc. | 2024-12-03 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S801) | Medtronic, Inc. | 2024-12-02 |
| CapSureFix Novus Lead (P930039/S267) | Medtronic, Inc. | 2024-12-02 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD (P980016/S909) | Medtronic Cardiac Rhythm Disease Management | 2024-12-02 |
| CapSure Sense Lead (P830061/S227) | Medtronic Cardiac Rhythm Disease Management | 2024-12-02 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S875) | Medtronic Cardiac Rhythm Disease Management | 2024-12-02 |
| TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S092) | St Jude Medical | 2024-11-27 |
| Aurora EV ICD (P220012/S035) | Medtronic, Inc. | 2024-11-27 |
| 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/S907) | Medtronic Cardiac Rhythm Disease Management | 2024-11-27 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S015) | ABBOTT MEDICAL | 2024-11-27 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria Quad MRI CRT-D, Cobalt (P010031/S873) | Medtronic Cardiac Rhythm Disease Management | 2024-11-27 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S105) | Terumo Medical Corporation | 2024-11-26 |
| EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035/S073) | Boston Scientific Corp | 2024-11-26 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S063) | Boston Scientific Corp | 2024-11-26 |
| Innova Vascular Self Expanding Stent with Delivery System (P140028/S081) | Boston Scientific Corporation | 2024-11-26 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S055) | Medinol, Ltd. | 2024-11-26 |
| TriClip G4 Clip Delivery System (P230007/S008) | ABBOTT MEDICAL | 2024-11-25 |
| L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL DR, L30 (N970003/S297) | Boston Scientific Corp | 2024-11-25 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S201) | Boston Scientific Corporation | 2024-11-25 |
| Nitron CryoConsole, Nitron Foot Switch (P020045/S110) | Medtronic Cryocath, LP | 2024-11-25 |
| G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN CRT-D, (P010012/S588) | Boston Scientific Corp | 2024-11-25 |
| D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MINI IC (P960040/S503) | Boston Scientific | 2024-11-25 |
| Total Artificial Heart (P030011/S092) | Syncardia Systems, LLC | 2024-11-25 |
| MITRIS RESILIA Mitral Valve (P150048/S085) | Edwards Lifesciences, LLC | 2024-11-25 |
| RelayPro Thoracic Stent-Graft System (P200045/S005) | Bolton Medical, Inc. | 2024-11-25 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-expanding Peripheral Stent with Entrust Delivery Syste (P110023/S053) | Medtronic Vascular, Inc. | 2024-11-25 |
| U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S243) | Guidant Corp. | 2024-11-25 |
| L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, L31 (P150012/S163) | Boston Scientific | 2024-11-25 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S069) | ABBOTT MEDICAL | 2024-11-25 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S221) | Medtronic | 2024-11-25 |
| LifeVest® Wearable Defibrillator (P010030/S188) | Zoll Manufacturing Corporation | 2024-11-24 |
| Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular, (P150035/S020) | ABBOTT MEDICAL | 2024-11-22 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S035) | Medtronic Vascular, Inc. | 2024-11-22 |
| 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/S874) | Medtronic Cardiac Rhythm Disease Management | 2024-11-22 |
| RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S085) | Medtronic Vascular | 2024-11-22 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S145) | Boston Scientific Corp | 2024-11-22 |
| Aurora EV ICD (P220012/S036) | Medtronic, Inc. | 2024-11-22 |
| OUS Vitatron Application Software (P890003/S470) | Medtronic, Inc. | 2024-11-22 |
| 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/S908) | Medtronic Cardiac Rhythm Disease Management | 2024-11-22 |
| TactiCath Ablation Catheter, Sensor Enabled (P130026/S091) | St Jude Medical | 2024-11-22 |
| Affera Sphere-9 Mapping and Ablation Catheter (P240013/S002) | Medtronic, Inc. | 2024-11-22 |
| Avant, Entrant, Fortify, Fortify Assura, Gallant, Neutrino NxT (P910023/S473) | ABBOTT MEDICAL | 2024-11-22 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S014) | ABBOTT MEDICAL | 2024-11-22 |
| Sphere-9 Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set (P240013/S001) | Medtronic, Inc. | 2024-11-22 |
| Avant, Entrant, Gallant, Neutrino NxT, Quadra Assura, Unify, Unify Assura, Unify Quadra (P030054/S428) | ABBOTT MEDICAL | 2024-11-22 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S086) | Medtronic, Inc. | 2024-11-22 |
| 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/S800) | Medtronic, Inc. | 2024-11-21 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S552) | Medtronic, Inc. | 2024-11-21 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) (P040044/S107) | Cordis US Corporation | 2024-11-21 |
| Philips Laser System (P910001/S123) | Spectranetics Corp. | 2024-11-21 |
| Roadsaver/CASPER Carotid Stent Device (P210030) | MicroVention, Inc. | 2024-11-20 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S126) | Medtronic Vascular | 2024-11-20 |
| 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/S906) | Medtronic Cardiac Rhythm Disease Management | 2024-11-20 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S551) | Medtronic, Inc. | 2024-11-20 |
| Thermocool SmartTouch Bi-Directional Navigation Catheter, Thermocool SmartTouch Uni-Directional Navigation Catheter (P040036/S099) | Biosense Webster, Inc. | 2024-11-20 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S047) | Berlin Heart, Inc. | 2024-11-20 |
| Theermocool SF NAV Bi-Directional Catheter (P990071/S062) | Biosense Webster, Inc. | 2024-11-20 |
| 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/S799) | Medtronic, Inc. | 2024-11-20 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S194) | Medtronic, Inc. | 2024-11-20 |