| Carotid Wallstent Monorail Endoprosthesis (P050019/S043) | Boston Scientific Corp | 2025-09-19 |
| Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S060) | Abiomed, Inc. | 2025-09-19 |
| Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard I (P240009/S005) | Contego Medical, Inc. | 2025-09-19 |
| DETOUR System (P220021/S005) | Endologix, LLC | 2025-09-18 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S012) | ABBOTT MEDICAL | 2025-09-18 |
| ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (P140016/S015) | Cook Medical Incorporated | 2025-09-18 |
| HeartSine samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (P160008/S027) | Heartsine Technologies, Ltd. | 2025-09-17 |
| Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201 (P150035/S030) | ABBOTT MEDICAL | 2025-09-17 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S085) | ABBOTT MEDICAL | 2025-09-17 |
| ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM (P960004/S110) | Boston Scientific | 2025-09-16 |
| ACC SUP FIXATION TOOL (P960006/S057) | Boston Scientific | 2025-09-16 |
| ACC SUP VEIN PICK (P830060/S091) | Boston Scientific | 2025-09-16 |
| ACC WRENCH (P930035/S035) | Boston Scientific | 2025-09-16 |
| ACC SUP SUTURE SLEEVE; ACC SUP FLUSHING TOOL; ACC WRENCH TORQUE-BI; ACC SUP LD CAP LV1 (P010012/S597) | Boston Scientific Corp | 2025-09-16 |
| ACC SUP PLUG (P910077/S196) | Boston Scientific | 2025-09-16 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S596) | Boston Scientific Corp | 2025-09-16 |
| IN.PACT AV Paclitaxel-coated PTA Balloon Catheter (P190008/S045) | Medtronic Vascular, Inc. | 2025-09-16 |
| IN.PACT Admiral Paclitaxelcoated PTA Balloon Catheter; IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter (P140010/S100) | Medtronic, Inc. | 2025-09-16 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S205) | Boston Scientific Corporation | 2025-09-16 |
| ACC STY TPR 0.013 - Accessory Stylet Straight, X-Soft; ACC STY 0.014 SOFT LONG TPR - Accessory Stylet Long Taper, Soft; (P150012/S171) | Boston Scientific | 2025-09-16 |
| ACC SUP CONNECTOR QUAD PSA TO IS4; ACC SUP SUTURE SLEEVE; ACC SUP KIT LD CAP; STRL PKG LEAD REPAIR KIT; ACC STY STR .016 (P910073/S183) | Boston Scientific | 2025-09-16 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S509) | Boston Scientific | 2025-09-16 |
| Purge Cassette (P170011/S058) | Abiomed, Inc. | 2025-09-15 |
| Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (P000009/S121) | Biotronik, Inc. | 2025-09-15 |
| 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/S137) | Biotronik, Inc. | 2025-09-15 |
| Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462 (P050023/S201) | Biotronik, Inc. | 2025-09-15 |
| Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (P010031/S902) | Medtronic Cardiac Rhythm Disease Management | 2025-09-15 |
| Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (P140003/S126) | Abiomed, Inc. | 2025-09-15 |
| 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/S170) | Biotronik, Inc. | 2025-09-15 |
| SMARTABLATE System Interface Cable (D-1303-02-S) (P990071/S067) | Biosense Webster, Inc. | 2025-09-15 |
| Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (P980016/S936) | Medtronic Cardiac Rhythm Disease Management | 2025-09-15 |
| Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (P950037/S276) | Biotronik, Inc. | 2025-09-15 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| iCast Covered Stent System (P120003/S011) | Atrium Medical Corp. | 2025-09-12 |
| PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System (P030047/S051) | Cordis US Corporation | 2025-09-12 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S030) | Terumo Medical Corporation | 2025-09-12 |
| S.M.A.R.T.® CONTROL® Vascular Stent System (P120002/S032) | Cordis US Corporation | 2025-09-12 |
| S.M.A.R.T.® CONTROL® Nitinol Stent System (P020036/S057) | Cordis US Corporation | 2025-09-12 |
| Edwards EVOQUE tricuspid delivery system (P230013/S018) | Edwards Lifesciences, LLC | 2025-09-12 |
| EXCOR Cannula Clip (P160035/S049) | Berlin Heart, Inc. | 2025-09-12 |
| Minima Stent System (P240003/S004) | Renata Medical, Inc. | 2025-09-11 |
| Aurora EV-ICD System (P220012/S054) | Medtronic, Inc. | 2025-09-11 |
| Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (P950037/S275) | Biotronik, Inc. | 2025-09-11 |
| ReCor Paradise Catheter (P220023/S009) | Recor Medical, Inc. | 2025-09-11 |
| 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 (4071 (P070008/S169) | Biotronik, Inc. | 2025-09-11 |
| Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (P050023/S200) | Biotronik, Inc. | 2025-09-11 |
| VARIPULSE Catheter (P240006/S011) | Biosense Webster, Inc. | 2025-09-10 |
| CardioMEMSTM HF System (P100045/S084) | ABBOTT MEDICAL | 2025-09-10 |
| RelayPro Thoracic Stent-Graft System (P200045/S020) | Bolton Medical, Inc. | 2025-09-10 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S019) | Endotronix, Inc. | 2025-09-10 |
| Implantable Cardioverter Defibrillator (ICD) (P980016/S931) | Medtronic Cardiac Rhythm Disease Management | 2025-09-09 |
| GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S203) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S009) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| Cardiac Resynchronization Therapy -Defibrillator (CRT-D) (P010031/S897) | Medtronic Cardiac Rhythm Disease Management | 2025-09-09 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S023) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S025) | Edwards Lifesciences, LLC | 2025-09-09 |
| Conformable GORE® TAG® Thoracic Endoprosthesis (P040043/S145) | W. L. Gore & Associates, Inc. | 2025-09-09 |
| Harmony TPV System (P200046/S043) | Medtronic, Inc. | 2025-09-05 |
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C (P010015/S570) | Medtronic, Inc. | 2025-09-05 |
| Percepta Bipolar CRT-P W1TR1; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P W (P980016/S935) | Medtronic Cardiac Rhythm Disease Management | 2025-09-05 |
| Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01) (P150033/S216) | Medtronic, Inc. | 2025-09-05 |
| Aurora EV-ICD System (DVEA3E4) (P220012/S057) | Medtronic, Inc. | 2025-09-05 |
| Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az (P980035/S821) | Medtronic, Inc. | 2025-09-05 |
| AVEIR Leadless Pacemaker (P150035/S031) | ABBOTT MEDICAL | 2025-09-05 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S901) | Medtronic Cardiac Rhythm Disease Management | 2025-09-05 |
| Lutonix 018 (Model 9014) (P170003/S028) | Lutonix | 2025-09-04 |
| Sphere-9 Mapping and Ablation Catheter (P240013/S010) | Medtronic, Inc. | 2025-09-04 |
| Lutonix 035 (Model 9004 and Model 9010) (P130024/S044) | Lutonix | 2025-09-04 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S077) | Boston Scientific Corp | 2025-09-04 |
| Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020/S005) | Sirtex Medical, Inc. | 2025-09-03 |
| RelayPlus (P110038/S034) | Bolton Medical, Inc. | 2025-09-03 |
| RelayPro (P200045/S019) | Bolton Medical, Inc. | 2025-09-03 |
| TREO® Abdominal Stent-Graft System (P190015/S025) | Bolton Medical, Inc. | 2025-09-03 |
| ACUITY X4 Straight, Models 4671 and 4672; ACUITY X4 Spiral S, Models 4674 and 4675; ACUITY X4 Spiral L, Models 4677 and (P010012/S591) | Boston Scientific Corp | 2025-09-03 |
| WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (P240028/S002) | EBR Systems, Inc. | 2025-09-03 |
| HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories (P160008/S029) | Heartsine Technologies, Ltd. | 2025-09-02 |
| Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation (P150005/S088) | Boston Scientific Corp | 2025-09-02 |
| Sphere-9 Catheter Mapping and Ablation Catheter (P240013/S015) | Medtronic, Inc. | 2025-08-29 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00 (P200030/S022) | W. L. Gore and Associates, Inc. | 2025-08-29 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S014) | ABBOTT MEDICAL | 2025-08-29 |
| GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) 00733132646890; 00733132646906; 007331326 (P040043/S144) | W. L. Gore & Associates, Inc. | 2025-08-29 |
| AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160022/S042) | ZOLL Medical Corporation | 2025-08-28 |
| AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160015/S020) | ZOLL Medical Corporation | 2025-08-28 |
| Avant DR CDDRA700Q, CDDRA700T; Gallant DR CDDRA500Q, CDDRA500T; Entrant DR CDDRA300Q, CDDRA300T; Neutrino NxT DR CDD (P910023/S479) | ABBOTT MEDICAL | 2025-08-27 |
| Globe® Pulsed Field System (P240044) | Kardium, Inc. | 2025-08-27 |
| IsoFlex (1944) (P960030/S081) | ABBOTT MEDICAL | 2025-08-27 |
| Quartet 1456Q, 1457Q, 1458Q, 1458QL; Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant HF CDHFA500B, CDHFA (P030054/S436) | ABBOTT MEDICAL | 2025-08-27 |
| Evolut PRO+ System, Evolut FX System, Evolut FX+ System (P130021/S174) | Medtronic, Inc. | 2025-08-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S110) | ABBOTT MEDICAL | 2025-08-27 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S028) | Heartsine Technologies, Ltd. | 2025-08-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S111) | ABBOTT MEDICAL | 2025-08-26 |
| CorPASS System (P230040/S018) | Endotronix, Inc. | 2025-08-26 |
| XACT Carotid Stent System (P040038/S049) | Abbott Vascular, Inc. | 2025-08-25 |
| TAG® Thoracic Branch Endoprosthesis (P210032) (P210032/S022) | W. L. Gore & Associates, Inc. | 2025-08-25 |
| CardioMessenger Smart 4G (P050023/S197) | Biotronik, Inc. | 2025-08-22 |
| FINELINE® II EZ Sterox (P960004/S106) | Boston Scientific | 2025-08-22 |
| INGEVITY MRI, INGEVITY + (P150012/S153) | Boston Scientific | 2025-08-22 |
| ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT (P910073/S176) | Boston Scientific | 2025-08-22 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection (P240009/S004) | Contego Medical, Inc. | 2025-08-22 |