| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S009) | Edwards Lifesciences, LLC | 2024-08-30 |
| HeartWare® HVAD System (P100047/S220) | Medtronic | 2024-08-30 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P), Pulse Generator, Permanent, Implantable (P950037/S255) | Biotronik, Inc. | 2024-08-30 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S865) | Medtronic Cardiac Rhythm Disease Management | 2024-08-29 |
| Lutonix Drug Coated Balloon PTA Catheter (P170003/S026) | Lutonix | 2024-08-29 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S899) | Medtronic Cardiac Rhythm Disease Management | 2024-08-29 |
| Aveir VR Delivery Catheter, Aveir DR Delivery Catheter (P150035/S015) | ABBOTT MEDICAL | 2024-08-29 |
| CardioMEMS HF System (P100045/S076) | ABBOTT MEDICAL | 2024-08-29 |
| Advanced Valve Metal (AVM) capacitor (P220012/S029) | Medtronic, Inc. | 2024-08-28 |
| Cardiac Resynchronization Therapy Pacemaker (CRT-P) (P030005/S240) | Guidant Corp. | 2024-08-28 |
| Cannula with Guide (P200002/S009) | AtriCure, Inc. | 2024-08-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S084) | ABBOTT MEDICAL | 2024-08-28 |
| Advanced Valve Metal (AVM) capacitor (P010031/S864) | Medtronic Cardiac Rhythm Disease Management | 2024-08-28 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S186) | Zoll Manufacturing Corporation | 2024-08-28 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S006) | ABBOTT MEDICAL | 2024-08-28 |
| Minima Stent System (P240003) | Renata Medical, Inc. | 2024-08-28 |
| HeartMate II Left Ventricular Assist System (P060040/S106) | ABBOTT MEDICAL | 2024-08-28 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S585) | Boston Scientific Corp | 2024-08-28 |
| Medtronic SelectSecure Lead Model 3830 (P030036/S147) | Medtronic Cardiac Rhythm Disease Management | 2024-08-28 |
| Advanced Valve Metal (AVM) capacitor (P980016/S898) | Medtronic Cardiac Rhythm Disease Management | 2024-08-28 |
| EluNIR & EluNIR-PERL Ridaforolimus Eluting Coronary Stent Systems (P170008/S049) | Medinol, Ltd. | 2024-08-27 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S003) | Endotronix, Inc. | 2024-08-27 |
| LifeVest® Wearable Defibrillator (P010030/S185) | Zoll Manufacturing Corporation | 2024-08-27 |
| POLARx FIT Cryoablation Balloon Catheters (P220032/S007) | Boston Scientific Corporation | 2024-08-23 |
| ESPRIT BTK Everolimus Eluting Bioresorbable Scaffold System (P230036/S004) | ABBOTT MEDICAL | 2024-08-23 |
| Angio-Seal VIP Vascular Closure Devices (P930038/S102) | Terumo Medical Corporation | 2024-08-23 |
| ResQCPR System (P110024/S006) | ZOLL Medical Corporation | 2024-08-22 |
| AFX2 Endovascular AAA System (P040002/S073) | Endologix, LLC | 2024-08-22 |
| AFX2 Endovascular AAA System (P040002/S072) | Endologix, LLC | 2024-08-22 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S002) | Endotronix, Inc. | 2024-08-22 |
| Symplicity G3 Renal Denervation RF Generator (P220026/S009) | Medtronic, Inc. | 2024-08-21 |
| Protégé GPS Self-Expanding Peripheral Stent System (P060001/S044) | Medtronic Vascular, Inc. | 2024-08-21 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S004) | Surmodics,Inc. | 2024-08-20 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) (P040044/S102) | Cordis US Corporation | 2024-08-20 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S139) | W. L. Gore & Associates, Inc. | 2024-08-16 |
| CapSureFix Novus Lead (P930039/S262) | Medtronic, Inc. | 2024-08-16 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S014) | W. L. Gore & Associates, Inc. | 2024-08-16 |
| SYNERGY , SYNERGY XD, SYNERGY MEGATRON and SYNERGY Shield Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S104) | Boston Scientific Corporation | 2024-08-16 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust (P110023/S050) | Medtronic Vascular, Inc. | 2024-08-15 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S046) | Berlin Heart, Inc. | 2024-08-15 |
| Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) (P810002/S122) | ABBOTT MEDICAL | 2024-08-15 |
| Tunneling Tool (P920015/S291) | Medtronic, Inc. | 2024-08-15 |
| EMBLEM SICD Lead (P110042/S197) | Boston Scientific Corporation | 2024-08-15 |
| Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter (P210015/S002) | Avive Solutions, Inc. | 2024-08-15 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S260) | Biotronik, Inc. | 2024-08-15 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S043) | Biotronik AG | 2024-08-14 |
| Guardian® System (P150009/S012) | Avertix Medical, Inc. | 2024-08-14 |
| TherOx DownStream System (P170027/S015) | Zoll Circulation, Inc. | 2024-08-14 |
| OPTIMIZER® Smart Mini (P180036/S029) | Impulse Dynamics (Usa), Inc. | 2024-08-13 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S007) | Edwards Lifesciences, LLC | 2024-08-13 |
| Harmony Transcathetrer Pulmonary Valve (P200046/S035) | Medtronic, Inc. | 2024-08-13 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S003) | W. L. Gore & Associates, Inc. | 2024-08-13 |
| Medtronic Core ValvE Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic (P130021/S167) | Medtronic, Inc. | 2024-08-13 |
| Injection Molding Crimper 9600CR Components (P200015/S056) | Edwards Lifesciences, LLC | 2024-08-12 |
| Injection Molding Crimper 9600CR Components (P140031/S176) | Edwards Lifesciences, LLC | 2024-08-12 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S052) | Medinol, Ltd. | 2024-08-07 |
| iCast Covered Stent System (P120003/S005) | Atrium Medical Corp. | 2024-08-07 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S051) | Medinol, Ltd. | 2024-08-07 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S008) | Edwards Lifesciences, LLC | 2024-08-07 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S025) | The Spectranetics Corp. | 2024-08-07 |
| DiamondTemp Ablation System (P200028/S024) | Medtronic, Inc. | 2024-08-06 |
| Heart Ware HVAD System (P100047/S218) | Medtronic | 2024-08-06 |
| TREO Abdominal Stent-Graft System (P190015/S021) | Bolton Medical, Inc. | 2024-08-06 |
| AngioJet Ultra 5000A Console (P980037/S093) | Boston Scientific Corp | 2024-08-05 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026/S001) | Goodman Co., Ltd. | 2024-08-02 |
| Avant, Entrant, Gallant, Neutrino NxT (P030054/S422) | ABBOTT MEDICAL | 2024-08-02 |
| Avant, Entrant, Gallant, Neutrino NxT (P910023/S467) | ABBOTT MEDICAL | 2024-08-02 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S002) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-01 |
| Thoraflex Hybrid (P210006/S009) | Vascutek, Ltd. | 2024-08-01 |
| CapSureFix Novus Lead (P930039/S261) | Medtronic, Inc. | 2024-08-01 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S185) | Medtronic, Inc. | 2024-08-01 |
| CapSureFix Novus Lead (P930039/S257) | Medtronic, Inc. | 2024-07-31 |
| Pulse Generator, Permanent Implantable (P950037/S259) | Biotronik, Inc. | 2024-07-31 |
| CapSure Sense Lead (P830061/S220) | Medtronic Cardiac Rhythm Disease Management | 2024-07-31 |
| Edwards Certitude Delivery System, Edwards Certitude Introducer Sheath Set, Edwards Commander Delivery System, Edwards C (P140031/S175) | Edwards Lifesciences, LLC | 2024-07-30 |
| EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System (P230013/S006) | Edwards Lifesciences, LLC | 2024-07-30 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S055) | Edwards Lifesciences, LLC | 2024-07-30 |
| PASCAL Precision Implant System, PASCAL Precision Guide Sheath (P220003/S017) | Edwards Lifesciences, LLC | 2024-07-30 |
| POLARx Short Tip (ST) Cryoablation Balloon Catheter, POLARx Long Tip (LT) Cryoablation Balloon Catheter, POLARx FIT S (P220032/S005) | Boston Scientific Corporation | 2024-07-30 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S005) | ABBOTT MEDICAL | 2024-07-26 |
| SYNERGY MEGATRON Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System (P950020/S143) | Boston Scientific Corp | 2024-07-26 |
| Visi-Pro Balloon-expandable Peripheral Stent System (P030045/S010) | Medtronic Vascular, Inc. | 2024-07-26 |
| HeartMate 3 Left Ventricular Assist System (P160054/S074) | ABBOTT MEDICAL | 2024-07-26 |
| SYNERGY, XD, SHIELD and MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S101) | Boston Scientific Corporation | 2024-07-26 |
| Epic Plus Tissue Heart Valves, Epic Max Tissue Heart Valves, Epic Tissue Heart Valves (P040021/S058) | ABBOTT MEDICAL | 2024-07-25 |
| Prostar XL Percutaneous Vascular Surgical System (P960043/S123) | Abbott Vascular, Inc. | 2024-07-25 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S040) | Biotronik AG | 2024-07-24 |
| RelayPlus Thorade Stent Graft System (P110038/S032) | Bolton Medical, Inc. | 2024-07-24 |
| iCast Covered Stent System (P120003/S004) | Atrium Medical Corp. | 2024-07-24 |
| RelayPro Thoracic Stent-Graft System (P200045/S013) | Bolton Medical, Inc. | 2024-07-24 |
| CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX Delivery Catheter System (P130021/S165) | Medtronic, Inc. | 2024-07-24 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S033) | Boston Scientific Corporation | 2024-07-23 |
| MT PAS ACUITY X4 (P010012/S581) | Boston Scientific Corp | 2024-07-22 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S185) | Medtronic, Inc. | 2024-07-22 |
| 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/S785) | Medtronic, Inc. | 2024-07-21 |
| TactiCath Ablation Catheter, Sensor Enabled (P130026/S089) | St Jude Medical | 2024-07-21 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S543) | Medtronic, Inc. | 2024-07-21 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S012) | ABBOTT MEDICAL | 2024-07-21 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S013) | Cook Medical Incorporated | 2024-07-19 |
| Zenith Dissection Endovascular System (P180001/S014) | William Cook Europe Aps | 2024-07-19 |