| Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S047) | Cardiovascular Systems, Inc. | 2025-06-03 |
| CentriMag Circulatory Support System (P170038/S024) | Abbott | 2025-06-02 |
| Lava Liquid Embolic System (Lava LES) (P220020/S006) | Sirtex Medical, Inc. | 2025-06-02 |
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S008) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-05-30 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S193) | Zoll Manufacturing Corporation | 2025-05-30 |
| Epsila EV Extravascular Lead (EV2401) (P220012/S050) | Medtronic, Inc. | 2025-05-30 |
| AED 3 Semi-Automatic, AED 3 Fully Automatic (P160015/S022) | ZOLL Medical Corporation | 2025-05-30 |
| Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (P010015/S562) | Medtronic, Inc. | 2025-05-30 |
| Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR (P980035/S811) | Medtronic, Inc. | 2025-05-30 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S191) | Zoll Manufacturing Corporation | 2025-05-30 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S016) | Shockwave Medical, Inc. | 2025-05-30 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S007) | Medtronic, Inc. | 2025-05-30 |
| AED 3 BLS (P160022/S044) | ZOLL Medical Corporation | 2025-05-30 |
| HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M) (P920015/S299) | Medtronic, Inc. | 2025-05-30 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S057) | Medinol, Ltd. | 2025-05-30 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S039) | Medtronic Vascular, Inc. | 2025-05-29 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S092) | Medtronic, Inc. | 2025-05-29 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S007) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-05-29 |
| S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S055) | Cordis US Corporation | 2025-05-28 |
| SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS (P120002/S030) | Cordis US Corporation | 2025-05-28 |
| ROTAPRO Rotational Atherectomy System (P900056/S220) | Boston Scientific Corp | 2025-05-28 |
| Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C (P010031/S890) | Medtronic Cardiac Rhythm Disease Management | 2025-05-28 |
| Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1; Cobalt XT MRI ICD (P980016/S924) | Medtronic Cardiac Rhythm Disease Management | 2025-05-28 |
| IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (P060019/S057) | Irvine Biomedical, Inc. | 2025-05-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S100) | ABBOTT MEDICAL | 2025-05-23 |
| Tendyne Transcatheter Mitral Valve System (P240042) | ABBOTT MEDICAL | 2025-05-23 |
| Barostim System (P180050/S014) | Cvrx, Inc. | 2025-05-23 |
| HeartMate II Left Ventricular Assist System (P060040/S115) | ABBOTT MEDICAL | 2025-05-23 |
| Endurity MRI, Assurity MRI (P140033/S097) | ABBOTT MEDICAL | 2025-05-22 |
| Tendril STS, Optisense (P960013/S128) | ABBOTT MEDICAL | 2025-05-22 |
| Durata, Optisure (P950022/S147) | ABBOTT MEDICAL | 2025-05-22 |
| Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR (P880086/S343) | ABBOTT MEDICAL | 2025-05-22 |
| Sphere-9 Ablation and Mapping Catheter - AFR-00001 (P240013/S006) | Medtronic, Inc. | 2025-05-22 |
| Avant HF, Avant HF, Gallant HF, Entrant HF, Quadra Assura MP, Quadra Assura, Unify Assura, Quartet, QuickFlex Micro (P030054/S434) | ABBOTT MEDICAL | 2025-05-22 |
| IsoFlex (P960030/S079) | ABBOTT MEDICAL | 2025-05-22 |
| Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR, Ellipse VR, Ellips (P910023/S478) | ABBOTT MEDICAL | 2025-05-22 |
| Aveir VR (P150035/S025) | ABBOTT MEDICAL | 2025-05-22 |
| Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF (P030035/S209) | ABBOTT MEDICAL | 2025-05-22 |
| Microny II SR+ (P970013/S098) | ABBOTT MEDICAL | 2025-05-22 |
| HeartMate 3 Left Ventricular Assist System (P160054/S106) | ABBOTT MEDICAL | 2025-05-21 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S119) | ABBOTT MEDICAL | 2025-05-21 |
| Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device) (P160021/S047) | W. L. Gore & Associates, Inc. | 2025-05-20 |
| ROTAPRO Rotational Atherectomy System (P900056/S219) | Boston Scientific Corp | 2025-05-20 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) (P230023/S006) | W. L. Gore & Associates, Inc. | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S188) | Edwards Lifesciences, LLC | 2025-05-20 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S065) | Edwards Lifesciences, LLC | 2025-05-20 |
| VenaSeal Closure System (P140018/S044) | Medtronic Vascular, Inc. | 2025-05-20 |
| Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra (P110019/S135) | Abbott Vascular | 2025-05-19 |
| Zenith Dissection Endovascular System (P180001/S015) | William Cook Europe Aps | 2025-05-19 |
| MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (P100009/S074) | ABBOTT MEDICAL | 2025-05-18 |
| TriClip G4 Delivery System;TriClip G5 Delivery System (P230007/S012) | ABBOTT MEDICAL | 2025-05-18 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S054) | Biotronik AG | 2025-05-15 |
| Epsila EV Transverse Tunneling Tool (P220012/S044) | Medtronic, Inc. | 2025-05-15 |
| INCRAFT® AAA Stent Graft System (P150002/S012) | Cordis US Corporation | 2025-05-15 |
| CardioMEMS HF System (P100045/S081) | ABBOTT MEDICAL | 2025-05-15 |
| S.M.A.R.T.® CONTROL® Nitinol Stent System, S.M.A.R.T. RADIANZTM Vascular Stent System (P020036/S056) | Cordis US Corporation | 2025-05-15 |
| EXOSEAL® Vascular Closure Device (P100013/S030) | Cordis US Corporation | 2025-05-15 |
| CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V (P900060/S068) | Corcym S.r.l. | 2025-05-15 |
| EndoForce Connector for Endovascular Venous Anastomosis (P240004) | Phraxis, Inc. | 2025-05-15 |
| S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems, S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S031) | Cordis US Corporation | 2025-05-15 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S191) | Medtronic, Inc. | 2025-05-14 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S013) | Endotronix, Inc. | 2025-05-13 |
| LifeVest® Wearable Defibrillator (P010030/S192) | Zoll Manufacturing Corporation | 2025-05-13 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S041) | Medtronic, Inc. | 2025-05-13 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S014) | Endotronix, Inc. | 2025-05-13 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FR3 Defibrillator (P160028/S006) | Philips Medical Systems, Inc. | 2025-05-09 |
| Mynx Control Vascular Closure Device (P040044/S109) | Cordis US Corporation | 2025-05-09 |
| TRIDYNE Vascular Sealant (P150016/S025) | Neomend, Inc. | 2025-05-09 |
| MITRACLIP DELIVERY SYSTEM (P100009/S071) | ABBOTT MEDICAL | 2025-05-09 |
| PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS (P060001/S047) | Medtronic Vascular, Inc. | 2025-05-09 |
| EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S058) | Medtronic Vascular, Inc. | 2025-05-09 |
| VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; nGEN (TM) Pump (P240006/S001) | Biosense Webster, Inc. | 2025-05-09 |
| TriClip G4 System (P230007/S010) | ABBOTT MEDICAL | 2025-05-09 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S105) | ABBOTT MEDICAL | 2025-05-08 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |
| HeartMate II Left Ventricular Assist System (P060040/S118) | ABBOTT MEDICAL | 2025-05-08 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S125) | Medtronic Vascular | 2025-05-08 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S041) | ZOLL Medical Corporation | 2025-05-07 |
| Navitor Transcatheter Aortic Valve Implantation System (P190023/S025) | ABBOTT MEDICAL | 2025-05-07 |
| Protégé RX Carotid Stent System; Protégé GPS Self-expanding Peripheral Stent System (P060001/S048) | Medtronic Vascular, Inc. | 2025-05-07 |
| CapSureFix MRI Lead (P090013/S333) | Medtronic, Inc. | 2025-05-06 |
| CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead (P930039/S263) | Medtronic, Inc. | 2025-05-06 |
| MitraClip G4 Clip Delivery System (P100009/S072) | ABBOTT MEDICAL | 2025-05-06 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S090) | ABBOTT MEDICAL | 2025-05-06 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S095) | St Jude Medical | 2025-05-06 |
| EXCOR Connecting and Extension Sets (P160035/S050) | Berlin Heart, Inc. | 2025-05-06 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D (P130013/S075) | Boston Scientific Corp | 2025-05-05 |
| HeartWare HVAD System (P100047/S226) | Medtronic | 2025-05-05 |
| AngioJet Thrombectomy System - AutoElite Console (P980037/S094) | Boston Scientific Corp | 2025-05-01 |
| Micra Transcatheter Pacing System: MC1AVR1; MC2AVR1; MC1VR01; MC2VR01 (P150033/S206) | Medtronic, Inc. | 2025-05-01 |
| iCast Covered Stent System (P120003/S008) | Atrium Medical Corp. | 2025-05-01 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (P230022) | Element Science, Inc. | 2025-04-30 |
| Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system (P140031/S182) | Edwards Lifesciences, LLC | 2025-04-30 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S006) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-29 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S004) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-26 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S003) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-25 |
| Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; (P980016/S922) | Medtronic Cardiac Rhythm Disease Management | 2025-04-25 |