| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S046) | W. L. Gore & Associates, Inc. | 2024-06-18 |
| Cobalt MRI CRTD, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S854) | Medtronic Cardiac Rhythm Disease Management | 2024-06-17 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S024) | The Spectranetics Corp. | 2024-06-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S888) | Medtronic Cardiac Rhythm Disease Management | 2024-06-17 |
| LifeVest Wearable Defibrillator (P010030/S179) | Zoll Manufacturing Corporation | 2024-06-14 |
| OPTIMIZER Smart, Smart Mini, and Lite Systems (P180036/S030) | Impulse Dynamics (Usa), Inc. | 2024-06-14 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S069) | Boston Scientific Corp | 2024-06-14 |
| PSW 2401.U, NEO 2401.U (P050023/S183) | Biotronik, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P070008/S157) | Biotronik, Inc. | 2024-06-13 |
| OPTIMIZER® Smart Mini (P180036/S028) | Impulse Dynamics (Usa), Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P950037/S257) | Biotronik, Inc. | 2024-06-13 |
| PSW 2401.U, NEO 2401.U (P000009/S110) | Biotronik, Inc. | 2024-06-13 |
| Tendril MRI Pacing Lead (P140033/S090) | ABBOTT MEDICAL | 2024-06-12 |
| UltiPace Pacing Lead, Tendril STS Pacing Lead (P960013/S125) | ABBOTT MEDICAL | 2024-06-12 |
| CentriMag Circulatory Support System (P170038/S018) | Abbott | 2024-06-11 |
| Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack (P200032/S001) | Occlutech Holding AG | 2024-06-07 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S012) | Teleflex Medical, LLC | 2024-06-07 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S861) | Medtronic Cardiac Rhythm Disease Management | 2024-06-07 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S895) | Medtronic Cardiac Rhythm Disease Management | 2024-06-07 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S147) | Medtronic Cryocath, LP | 2024-06-07 |
| Aveir Delivery Catheter (P150035/S011) | ABBOTT MEDICAL | 2024-06-06 |
| TherOx Downstream System (P170027/S011) | Zoll Circulation, Inc. | 2024-06-06 |
| Preveleak Surgical Sealant, Preveleak 10-Pack delivery Tips (P100030/S019) | Baxter Healthcare Corporation | 2024-06-06 |
| TherOx® DownStream® Cartridge (DSC-2) (P170027/S012) | Zoll Circulation, Inc. | 2024-06-06 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026) | Goodman Co., Ltd. | 2024-06-06 |
| ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S039) | Biotronik AG | 2024-06-06 |
| SW016 / Application Software, SWCOMBO / Application Software, SW033 / Application Software (P980016/S893) | Medtronic Cardiac Rhythm Disease Management | 2024-06-05 |
| SW009, SW016, SWCOMBO / Application Software (P010031/S859) | Medtronic Cardiac Rhythm Disease Management | 2024-06-05 |
| EAZ101 / Epsila EV Sternal Tunneling Tool, EAZ201 / Epsila EV Transverse Tunneling Tool (P220012/S026) | Medtronic, Inc. | 2024-06-05 |
| Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S217) | Boston Scientific Corp | 2024-06-05 |
| SWCOMBO / Application Software, SW030 / Application Software (P980035/S782) | Medtronic, Inc. | 2024-06-05 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S043) | Berlin Heart, Inc. | 2024-06-05 |
| SWCOMBO / Application Software (P090013/S331) | Medtronic, Inc. | 2024-06-05 |
| SW026, SWCOMBO / Application Software, SW036 / Application Software, 29901 / CareLink Encore Programmer, 2090 / CareLink (P890003/S467) | Medtronic, Inc. | 2024-06-05 |
| SW044, SWCOMBO / Application Software, SW022 / Micra AV Programming Software Model (P150033/S189) | Medtronic, Inc. | 2024-06-05 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S539) | Medtronic, Inc. | 2024-06-05 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S156) | Boston Scientific | 2024-06-04 |
| Aurora EV-ICD Application Software, Aurora EV-ICD (P220012/S018) | Medtronic, Inc. | 2024-06-04 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S044) | W. L. Gore & Associates, Inc. | 2024-06-04 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S292) | Boston Scientific Corp | 2024-06-04 |
| CRT-D MRI Application Software, Blackwell Application Software (P010031/S853) | Medtronic Cardiac Rhythm Disease Management | 2024-06-04 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S237) | Guidant Corp. | 2024-06-04 |
| HP MRI Application Software, Visia AF Application Software (P980016/S887) | Medtronic Cardiac Rhythm Disease Management | 2024-06-04 |
| Life Vest Wearable Defibrillator (P010030/S178) | Zoll Manufacturing Corporation | 2024-06-02 |
| Abre Venous Self-expanding Stent System (P200026/S009) | Medtronic Vascular, Inc. | 2024-05-31 |
| TriClip G4 System (P230007/S004) | ABBOTT MEDICAL | 2024-05-31 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S080) | ABBOTT MEDICAL | 2024-05-31 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S104) | ABBOTT MEDICAL | 2024-05-31 |
| TriClip G4 System (P230007/S003) | ABBOTT MEDICAL | 2024-05-31 |
| Protégé GPS Self-Expanding Peripheral Stent System, and Protégé RX Carotid Stent System (P060001/S041) | Medtronic Vascular, Inc. | 2024-05-31 |
| X Series, Propaq MD (P160022/S037) | ZOLL Medical Corporation | 2024-05-30 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S002) | ABBOTT MEDICAL | 2024-05-30 |
| VENASEAL CLOSURE SYSTEM (P140018/S041) | Medtronic Vascular, Inc. | 2024-05-30 |
| Epic Plus, Epic Plus Supra and Epic Max Valves in the Epic Valve Sterilization Process (P040021/S057) | ABBOTT MEDICAL | 2024-05-30 |
| Aurora EV-ICD (P220012/S027) | Medtronic, Inc. | 2024-05-29 |
| G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN C (P010012/S584) | Boston Scientific Corp | 2024-05-29 |
| Navitor TAVI System (P190023/S019) | ABBOTT MEDICAL | 2024-05-29 |
| L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL D (N970003/S294) | Boston Scientific Corp | 2024-05-29 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S001) | ABBOTT MEDICAL | 2024-05-29 |
| U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S239) | Guidant Corp. | 2024-05-29 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, automatic implantable cardioverter, with cardiac resync (P050023/S185) | Biotronik, Inc. | 2024-05-29 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT- (P010015/S540) | Medtronic, Inc. | 2024-05-29 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S196) | Boston Scientific Corporation | 2024-05-29 |
| 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/S860) | Medtronic Cardiac Rhythm Disease Management | 2024-05-29 |
| L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, (P150012/S159) | Boston Scientific | 2024-05-29 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S127) | Biotronik, Inc. | 2024-05-29 |
| Defibrillator, implantable, dual-chamber (P000009/S112) | Biotronik, Inc. | 2024-05-29 |
| D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI (P960040/S501) | Boston Scientific | 2024-05-29 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirr (P980016/S894) | Medtronic Cardiac Rhythm Disease Management | 2024-05-29 |
| QDOT MICRO Navigation Catheter (P210027/S009) | Biosense Webster, Inc. | 2024-05-27 |
| LIFEPAK 35 Monitor/Defibrillator (P160026/S049) | Physio-Control, Inc. | 2024-05-24 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S538) | Medtronic, Inc. | 2024-05-24 |
| THERMOCOOL SMARTTOUCH SF Catheter (P040036/S098) | Biosense Webster, Inc. | 2024-05-24 |
| 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/S781) | Medtronic, Inc. | 2024-05-24 |
| AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S092) | Boston Scientific Corp | 2024-05-24 |
| Inoue-Balloon Catheter (P910054/S009) | Toray Industries (America), Inc. | 2024-05-24 |
| THERMOCOOL SMARTTOUCH Catheter (P030031/S136) | Biosense Webster, Inc. | 2024-05-24 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S005) | Edwards Lifesciences, LLC | 2024-05-23 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S080) | Edwards Lifesciences, LLC | 2024-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P200015/S054) | Edwards Lifesciences, LLC | 2024-05-23 |
| Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN (P860057/S218) | Edwards Lifesciences, LLC | 2024-05-23 |
| 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/S857) | Medtronic Cardiac Rhythm Disease Management | 2024-05-23 |
| 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/S891) | Medtronic Cardiac Rhythm Disease Management | 2024-05-23 |
| Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems (P140031/S162) | Edwards Lifesciences, LLC | 2024-05-23 |
| EDWARDS INTUITY Elite Valve System (P150036/S075) | Edwards Lifesciences, LLC | 2024-05-23 |
| Aurora EV-ICD (P220012/S023) | Medtronic, Inc. | 2024-05-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S174) | Edwards Lifesciences, LLC | 2024-05-23 |
| TREO® Abdominal Stent-Graft System (P190015/S016) | Bolton Medical, Inc. | 2024-05-22 |
| QDOT MICRO Uni-Directional Navigation Catheter, QDOT MICRO Bi-Directional Navigation Catheter (P210027/S005) | Biosense Webster, Inc. | 2024-05-22 |
| Cool Point Tubing Set (P060019/S056) | Irvine Biomedical, Inc. | 2024-05-22 |
| ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S583) | Boston Scientific Corp | 2024-05-22 |
| Fortify, Fortify Assura, Ellipse (P910023/S466) | ABBOTT MEDICAL | 2024-05-22 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S023) | The Spectranetics Corp. | 2024-05-22 |
| RELIANCE 4-FRONT (P910073/S178) | Boston Scientific | 2024-05-22 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S421) | ABBOTT MEDICAL | 2024-05-22 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S122) | Abbott Vascular, Inc. | 2024-05-20 |
| Innova Vascular Self-Expanding Stent System (P140028/S080) | Boston Scientific Corporation | 2024-05-20 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S059) | Boston Scientific Corp | 2024-05-20 |
| Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60, (P980023/S126) | Biotronik, Inc. | 2024-05-19 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4 (P950037/S258) | Biotronik, Inc. | 2024-05-19 |