| 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 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S016) | Kestra Medical Technologies, Inc. | 2025-04-25 |
| Aurora EV ICD DVEA3E4 (P220012/S048) | Medtronic, Inc. | 2025-04-25 |
| Micra AV TPS MC1AVR1, MC2AVR1 Micra TPS MC1VR01 Micra VR TPS MC2VR01 (P150033/S205) | Medtronic, Inc. | 2025-04-25 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S071) | Boston Scientific Corp | 2025-04-25 |
| Consulta CRT-P C4TR01 Percepta Bipolar CRT-P W1TR01 Percepta Quadripolar CRT-P W4TR01 Serena Bipolar CRTP W1TR02 Serena (P010015/S561) | Medtronic, Inc. | 2025-04-25 |
| 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/S810) | Medtronic, Inc. | 2025-04-25 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava CRT-D DTBC1D1 Brava Q (P010031/S888) | Medtronic Cardiac Rhythm Disease Management | 2025-04-25 |
| HeartWare® HVAD System (P100047/S225) | Medtronic | 2025-04-24 |
| Exoseal Vascular Closure Device (P100013/S029) | Cordis US Corporation | 2025-04-24 |
| DIAMONDBACK 360® and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S045) | Cardiovascular Systems, Inc. | 2025-04-24 |
| Edwards Commander Delivery System (P200015/S064) | Edwards Lifesciences, LLC | 2025-04-23 |
| Edwards Commander Delivery System (P140031/S187) | Edwards Lifesciences, LLC | 2025-04-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S009) | ABBOTT MEDICAL | 2025-04-22 |
| OmniaSecure MRI SureScan Lead Model 3930M (P240036) | Medtronic, Inc. | 2025-04-22 |
| Occlutech® ASD Occluder and Occlutech® Pistol Pusher (P200032/S002) | Occlutech Holding AG | 2025-04-18 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S109) | Boston Scientific Corporation | 2025-04-18 |
| MitraClip Systems (P100009/S073) | ABBOTT MEDICAL | 2025-04-18 |
| TriClip Systems (P230007/S011) | ABBOTT MEDICAL | 2025-04-18 |
| AED Plus (P160015/S019) | ZOLL Medical Corporation | 2025-04-17 |
| Hancock II Bioprosthesis (P980043/S082) | Medtronic, Inc. | 2025-04-16 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S010) | ABBOTT MEDICAL | 2025-04-16 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S006) | Biosense Webster, Inc. | 2025-04-16 |
| Micra AV TPS MC1AVR1, MC2AVR1; Micra TPS MC1VR01; Micra VR TPS MC2VR01 (P150033/S204) | Medtronic, Inc. | 2025-04-16 |
| Hancock Modified Orifice Valved Conduit (P790007/S067) | Medtronic Heart Valves | 2025-04-16 |
| Freestyle Bioprosthesis (P970031/S074) | Medtronic, Inc. | 2025-04-16 |
| INGEVITY+ Active Fixation (P150012/S167) | Boston Scientific | 2025-04-16 |
| Mosaic Bioprosthesis (P990064/S091) | Medtronic, Inc. | 2025-04-16 |
| Home Monitoring System Version 3.52.0 (P050023/S162) | Biotronik, Inc. | 2025-04-15 |
| Vega Endocardial Pacing Leads (P130010/S003) | MicroPort CRM USA, Inc. | 2025-04-15 |