| Medtronic Attain Ability Model 4196 Lead (P080006/S190) | Medtronic, Inc. | 2025-03-20 |
| Aurora EV-ICD System (P220012/S043) | Medtronic, Inc. | 2025-03-20 |
| Activitrax Models 8400, 8402, 8403 (P850051/S085) | Medtronic, Inc. | 2025-03-20 |
| Medtronic PCD Tachyarrhythmia Control System (P900061/S175) | Medtronic Cardiac Rhythm Disease Management | 2025-03-20 |
| Revo MRI Surescan IPG and Pacing System (P090013/S336) | Medtronic, Inc. | 2025-03-20 |
| Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impulse II Excellence SS, Leads (P850089/S171) | Medtronic Cardiac Rhythm Disease Management | 2025-03-20 |
| Synergyst II Pulse Generator Models 7070 & 7071 (P890003/S475) | Medtronic, Inc. | 2025-03-20 |
| Model 5071 Lead (P120017/S038) | Medtronic, Inc. | 2025-03-20 |
| MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S270) | Medtronic, Inc. | 2025-03-20 |
| Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators (P980016/S918) | Medtronic Cardiac Rhythm Disease Management | 2025-03-20 |
| Medtronic.Kappa 400 Series Pacemakers (P970012/S101) | Medtronic, Inc. | 2025-03-20 |
| Steroid TIP(TM) Model 4503 & 4003 Transvenous Pacing (P830061/S230) | Medtronic Cardiac Rhythm Disease Management | 2025-03-20 |
| Diva Platform Implantable Pulse Generators; PRO VIT Application Software (P990001/S123) | Medtronic, Inc. | 2025-03-20 |
| Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization (P010031/S884) | Medtronic Cardiac Rhythm Disease Management | 2025-03-20 |
| MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF (P980050/S145) | Medtronic, Inc. | 2025-03-20 |
| Versatrax Model 7000 Universal A-V Pulse Generator (P820003/S144) | Medtronic Cardiac Rhythm Disease Management | 2025-03-20 |
| Medtronic Insync Biventrical Pacing System (P010015/S558) | Medtronic, Inc. | 2025-03-20 |
| IntellaNav ST Ablation Catheter (P920047/S135) | Boston Scientific Corp | 2025-03-20 |
| Medtronic(R) Transvene Lead System (P920015/S297) | Medtronic, Inc. | 2025-03-20 |
| Medtronic(R) Legend Plus(TM) Pulse Generator (P930022/S020) | Medtronic, Inc. | 2025-03-20 |
| Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software (P980035/S807) | Medtronic, Inc. | 2025-03-20 |
| Medtronic (R) CapSure (R) EPI Pacing Lead (P950024/S114) | Medtronic, Inc. | 2025-03-20 |
| IntellaNav MiFi XP Ablation Catheter (P020025/S144) | Boston Scientific | 2025-03-20 |
| Attain Starfix Model 4195 Lead (P060039/S118) | Medtronic, Inc. | 2025-03-20 |
| Medtronic Micra Transcatheter Pacemaker System (P150033/S201) | Medtronic, Inc. | 2025-03-20 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S151) | Medtronic Cryocath, LP | 2025-03-18 |
| OPTIMIZER Smart System (P180036/S037) | Impulse Dynamics (Usa), Inc. | 2025-03-18 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S559) | Medtronic, Inc. | 2025-03-18 |
| Cobalt MRI ICD; Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; (P980016/S919) | Medtronic Cardiac Rhythm Disease Management | 2025-03-18 |
| Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Vers (P980035/S808) | Medtronic, Inc. | 2025-03-18 |
| Micra AV TPS; Micra TPS; Micra VR TPS (P150033/S202) | Medtronic, Inc. | 2025-03-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S099) | ABBOTT MEDICAL | 2025-03-18 |
| BioGlue® Surgical Adhesive (P010003/S042) | Cryolife, Inc. | 2025-03-18 |
| Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; (P010031/S885) | Medtronic Cardiac Rhythm Disease Management | 2025-03-18 |
| Aurora EV-ICD (P220012/S045) | Medtronic, Inc. | 2025-03-18 |
| LIFEPAK® 35 monitor/defibrillator (P160026/S053) | Physio-Control, Inc. | 2025-03-17 |
| TREO Abdominal Stent-Graft System (P190015/S023) | Bolton Medical, Inc. | 2025-03-14 |
| GORE CARDIOFORM Septal Occluder (P050006/S115) | W. L. Gore & Associates, Inc. | 2025-03-14 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxe (P140010/S089) | Medtronic, Inc. | 2025-03-14 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222) | Medtronic | 2025-03-13 |
| Harmony Transcatheter Pulmonary Valve (P200046/S037) | Medtronic, Inc. | 2025-03-13 |
| CoreValve Evolut PRO Transcatheter Aortic Valve; Evolut PRO+ Transcatheter Aortic Valve; Evolut FX Transcatheter Aortic (P130021/S173) | Medtronic, Inc. | 2025-03-13 |
| Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve (P150011/S028) | Corcym S.r.l. | 2025-03-12 |
| HeartMate 3 Left Ventricular Assist System (P160054/S098) | ABBOTT MEDICAL | 2025-03-12 |
| EXCOR® Apex Cannulae (P160035/S048) | Berlin Heart, Inc. | 2025-03-11 |
| Minima Stent System (P240003/S003) | Renata Medical, Inc. | 2025-03-11 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S019) | W. L. Gore and Associates, Inc. | 2025-03-11 |
| Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q (P050023/S190) | Biotronik, Inc. | 2025-03-10 |
| Pamira S DX 65/15, Pamira S DX 65/17, Plexa ProMRI S DX 65/15, Plexa ProMRI S DX 65/17 (P980023/S133) | Biotronik, Inc. | 2025-03-10 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S010) | Farapulse, Inc. | 2025-03-10 |
| Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60 (P950037/S267) | Biotronik, Inc. | 2025-03-10 |
| Corox (ProMRI) OTW 75 BP, Corox (ProMRI) OTW-S 75 BP, Corox (ProMRI) OTW-L 75 BP, Corox (ProMRI) OTW 85 BP, Corox (ProMR (P070008/S163) | Biotronik, Inc. | 2025-03-10 |
| StarClose SE Vascular Surgical System (P050007/S046) | Abbott Vascular Devices | 2025-03-09 |
| Supera Peripheral Stent System (P120020/S033) | Abbott Vascular (Idef Technologies Inc) | 2025-03-09 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S003) | Boston Scientific Corporation | 2025-03-09 |
| XACT Carotid Stent System (P040038/S047) | Abbott Vascular, Inc. | 2025-03-09 |
| Perclose ProGlide Suture-Mediated Closure System, Prostar XL Percutaneous Vascular Surgical System (P960043/S125) | Abbott Vascular, Inc. | 2025-03-09 |
| Parylene Tree Loading Machine (P160043/S086) | Medtronic Vascular | 2025-03-07 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S057) | Medtronic Vascular, Inc. | 2025-03-07 |
| Protégé RX Carotid Stent System; Protégé GPS Self-Expanding Peripheral Stent System (P060001/S046) | Medtronic Vascular, Inc. | 2025-03-07 |
| Paradise Ultrasound Renal Denervation System; Paradise Catheter (P220023/S007) | Recor Medical, Inc. | 2025-03-06 |
| ZOLL OneStep Pediatric CPR Electrode (P160022/S035) | ZOLL Medical Corporation | 2025-03-05 |
| Amplatzer Septal Occluder (P000039/S081) | ABBOTT MEDICAL | 2025-03-05 |
| CoreValve EnVeo PRO Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Transcatheter Aortic Valve (P130021/S171) | Medtronic, Inc. | 2025-03-05 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S010) | ABBOTT MEDICAL | 2025-03-05 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S011) | ABBOTT MEDICAL | 2025-03-05 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S135) | Biotronik, Inc. | 2025-03-05 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S172) | Medtronic, Inc. | 2025-03-05 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S271) | Biotronik, Inc. | 2025-03-05 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T (P050023/S195) | Biotronik, Inc. | 2025-03-05 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S119) | Biotronik, Inc. | 2025-03-05 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S061) | Edwards Lifesciences, LLC | 2025-03-04 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S088) | Edwards Lifesciences, LLC | 2025-03-04 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, SAPIEN 3 Ultra RESILIA Tra (P140031/S183) | Edwards Lifesciences, LLC | 2025-03-04 |
| EPi-Sense and EPi-Sense ST Guided Coagulation System (P200002/S010) | AtriCure, Inc. | 2025-03-03 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S048) | Biotronik AG | 2025-03-03 |
| EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) (P150048/S089) | Edwards Lifesciences, LLC | 2025-03-03 |
| Astron (P140030/S017) | Biotronik AG | 2025-03-03 |
| Pulsar-18 T3 (P160025/S019) | Biotronik AG | 2025-03-03 |
| DETOUR System (P220021/S004) | Endologix, LLC | 2025-03-03 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S184) | Edwards Lifesciences, LLC | 2025-03-03 |
| GORE® EXCLUDER AAA Endoprosthesis; Iliac Branch Endoprosthesis (P020004/S198) | W. L. Gore & Associates, Inc. | 2025-03-03 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S055) | Medtronic Vascular, Inc. | 2025-02-28 |
| Epsila EV Extravascular Lead (P220012/S042) | Medtronic, Inc. | 2025-02-27 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P950005/S088) | Biosense Webster, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P030031/S138) | Biosense Webster, Inc. | 2025-02-26 |
| HeartMate 3 (HM3) Left Ventricular Assist System (P160054/S097) | ABBOTT MEDICAL | 2025-02-26 |
| RelayPro Thoracic Stent-Graft System (P200045/S015) | Bolton Medical, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P010068/S074) | Biosense Webster, Inc. | 2025-02-26 |
| SmartAblate System Interface Cable (P990071/S065) | Biosense Webster, Inc. | 2025-02-26 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S883) | Medtronic Cardiac Rhythm Disease Management | 2025-02-26 |
| HeartMate II (HMII) Left Ventricular Assist System (P060040/S114) | ABBOTT MEDICAL | 2025-02-26 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S917) | Medtronic Cardiac Rhythm Disease Management | 2025-02-26 |
| TX eco EXT Cable (P210027/S014) | Biosense Webster, Inc. | 2025-02-26 |
| Attain Ability Lead (P080006/S189) | Medtronic, Inc. | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P240006/S002) | Biosense Webster, Inc. | 2025-02-26 |
| Thermocool Deflectable Diagnostic/ Ablation Catheter (P040036/S100) | Biosense Webster, Inc. | 2025-02-25 |
| NAVISTAR DS Electrophysiology Catheter (P010068/S075) | Biosense Webster, Inc. | 2025-02-25 |
| QDOT MICRO System (P210027/S015) | Biosense Webster, Inc. | 2025-02-25 |
| Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe (P030031/S139) | Biosense Webster, Inc. | 2025-02-25 |