| Edora 8 HF-T QP 407137, Edora 8 HF-T 407138, Evity 8 HF-T QP 407139, Evity 8 HF-T 407140, Enitra 8 HF-T QP 407141, Enitr (P070008/S168) | Biotronik, Inc. | 2025-06-18 |
| Aurora EV-ICD System (P220012/S051) | Medtronic, Inc. | 2025-06-18 |
| Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C (P030054/S437) | ABBOTT MEDICAL | 2025-06-18 |
| Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, (P950022/S149) | ABBOTT MEDICAL | 2025-06-18 |
| P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, (P880086/S344) | ABBOTT MEDICAL | 2025-06-18 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S015) | Edwards Lifesciences, LLC | 2025-06-18 |
| OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead (P960013/S130) | ABBOTT MEDICAL | 2025-06-18 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Bra (P010031/S893) | Medtronic Cardiac Rhythm Disease Management | 2025-06-18 |
| Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser (P010015/S565) | Medtronic, Inc. | 2025-06-18 |
| Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI (P140033/S099) | ABBOTT MEDICAL | 2025-06-18 |
| CareLink SmartSync Device Manager Base, 24970A (P890003/S477) | Medtronic, Inc. | 2025-06-17 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S477) | ABBOTT MEDICAL | 2025-06-17 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S342) | ABBOTT MEDICAL | 2025-06-17 |
| Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (P980035/S813) | Medtronic, Inc. | 2025-06-17 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S096) | ABBOTT MEDICAL | 2025-06-17 |
| Synergy Ablation System (P100046/S019) | AtriCure, Inc. | 2025-06-17 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S208) | ABBOTT MEDICAL | 2025-06-17 |
| EPi-Sense Guided Coagulation System (P200002/S011) | AtriCure, Inc. | 2025-06-17 |
| Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (P010015/S564) | Medtronic, Inc. | 2025-06-17 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S433) | ABBOTT MEDICAL | 2025-06-17 |
| Aveir Leadless System (P150035/S023) | ABBOTT MEDICAL | 2025-06-17 |
| Microny family of Pacemakers (P970013/S097) | ABBOTT MEDICAL | 2025-06-17 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S170) | W. L. Gore & Associates, Inc. | 2025-06-13 |
| Aurora EV ICD DVEA3E4 (P220012/S049) | Medtronic, Inc. | 2025-06-13 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S006) | Medtronic, Inc. | 2025-06-13 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra (P010031/S891) | Medtronic Cardiac Rhythm Disease Management | 2025-06-13 |
| Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi (P980035/S812) | Medtronic, Inc. | 2025-06-13 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S109) | W. L. Gore & Associates, Inc. | 2025-06-13 |
| Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (P010015/S563) | Medtronic, Inc. | 2025-06-13 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (P980016/S925) | Medtronic Cardiac Rhythm Disease Management | 2025-06-13 |
| Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S207) | Medtronic, Inc. | 2025-06-13 |
| Harmony Transcatheter Pulmonary Valve System (P200046/S042) | Medtronic, Inc. | 2025-06-12 |
| Sentus QP Pacing Leads (P050023/S193) | Biotronik, Inc. | 2025-06-12 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S016) | Endotronix, Inc. | 2025-06-12 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Sentus QP Pacing Leads (P070008/S165) | Biotronik, Inc. | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S199) | W. L. Gore & Associates, Inc. | 2025-06-11 |
| Artegraft Collagen Vascular Graft (N16837/S036) | LeMaitre Vascular, Inc. | 2025-06-11 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S020) | W. L. Gore & Associates, Inc. | 2025-06-11 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete (P200039/S015) | Shockwave Medical, Inc. | 2025-06-10 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (P160029/S027) | Philips Medical Systems, Inc. | 2025-06-09 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S014) | Edwards Lifesciences, LLC | 2025-06-06 |
| SurVeil Drug-Coated Balloon (P210025/S006) | Surmodics,Inc. | 2025-06-06 |
| Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DVPB3D1; Cobalt XT MRI ICD DDPA2D1; Cobalt XT MRI ICD DVPA2D1; Crome MRI ICD DDPC (P980016/S923) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S913) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| GORE® VIABAHN® Endoprosthesis (P040037/S169) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S268) | Medtronic, Inc. | 2025-06-05 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S108) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D (P010031/S889) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S200) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| VARIPULSE Bi-Directional Catheter (P240006/S008) | Biosense Webster, Inc. | 2025-06-05 |
| CapSureFix MRI Lead (P090013/S335) | Medtronic, Inc. | 2025-06-05 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S008) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| GORE TAG Thoracic Branch Endoprosthesis (P210032/S021) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) (P200030/S021) | W. L. Gore and Associates, Inc. | 2025-06-05 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S879) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S229) | Medtronic | 2025-06-05 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (P200030/S020) | W. L. Gore and Associates, Inc. | 2025-06-05 |
| Conformable GORE® TAG® Thoracic Endoprosthesis (P040043/S142) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (P220003/S022) | Edwards Lifesciences, LLC | 2025-06-04 |
| Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 (P200015/S063) | Edwards Lifesciences, LLC | 2025-06-04 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228) | Medtronic | 2025-06-04 |
| HeartMate II Left Ventricular Assist System (P060040/S116) | ABBOTT MEDICAL | 2025-06-04 |
| HeartMate 3 Left Ventricular Assist System (P160054/S101) | ABBOTT MEDICAL | 2025-06-04 |
| Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed (P140031/S186) | Edwards Lifesciences, LLC | 2025-06-04 |
| OmniaSecure MRI SureScan Lead Model 3930M (P240036/S001) | Medtronic, Inc. | 2025-06-04 |
| Endotak Lead System (P910073/S181) | Boston Scientific | 2025-06-04 |
| EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE dilator kit: 9850DK EVOQUE loading system: 9850LS (P230013/S012) | Edwards Lifesciences, LLC | 2025-06-04 |
| NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral (P010012/S590) | Boston Scientific Corp | 2025-06-04 |
| 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 |