| Coseal Spray Set (P030039/S031) | Baxter Bio Science | 2025-08-21 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S019) | W. L. Gore & Associates, Inc. | 2025-08-21 |
| CentriMag Circulatory Support System (P170038/S026) | Abbott | 2025-08-21 |
| Melody Transcatheter Pumonary Valve System (P140017/S031) | Medtronic, Inc. | 2025-08-21 |
| Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S215) | Medtronic, Inc. | 2025-08-21 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S208) | Medtronic, Inc. | 2025-08-20 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S202) | W. L. Gore & Associates, Inc. | 2025-08-20 |
| iCast Covered Stent System (P120003/S010) | Atrium Medical Corp. | 2025-08-20 |
| TriClip G5 Delivery System (P230007/S015) | ABBOTT MEDICAL | 2025-08-20 |
| MitraClip G5 Delivery System (P100009/S078) | ABBOTT MEDICAL | 2025-08-20 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (P230022/S001) | Element Science, Inc. | 2025-08-20 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System (P170030/S055) | Biotronik AG | 2025-08-19 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004/S108) | Boston Scientific | 2025-08-19 |
| MitraClip Delivery System (P100009/S079) | ABBOTT MEDICAL | 2025-08-18 |
| TriClip Delivery System (P230007/S016) | ABBOTT MEDICAL | 2025-08-18 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Sten (P110019/S136) | Abbott Vascular | 2025-08-16 |
| AVEIR AR 2 LSP203A Leadless Pacemaker (LP) (atrial) (P150035/S029) | ABBOTT MEDICAL | 2025-08-15 |
| HexaGen RF Generator, HexaPulse PF Generator, HexaFlow Irrigation Pump (P240013/S013) | Medtronic, Inc. | 2025-08-15 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S060) | Medinol, Ltd. | 2025-08-15 |
| Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2) (P150033/S212) | Medtronic, Inc. | 2025-08-15 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve; Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtroni (P130021/S177) | Medtronic, Inc. | 2025-08-14 |
| ROTABLATOR Rotational Atherectomy System (P900056/S221) | Boston Scientific Corp | 2025-08-14 |
| FARAPULSE Pulsed Field Ablation System (P230030/S014) | Farapulse, Inc. | 2025-08-14 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S146) | Boston Scientific | 2025-08-14 |
| POLARx Cryoablation System (P220032/S011) | Boston Scientific Corporation | 2025-08-14 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S089) | Boston Scientific Corp | 2025-08-14 |
| Blazer II Cardiac Ablation System and Cable (P920047/S137) | Boston Scientific Corp | 2025-08-14 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S017) | Endotronix, Inc. | 2025-08-14 |
| Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System (P230013/S016) | Edwards Lifesciences, LLC | 2025-08-13 |
| LifeVest® Wearable Defibrillator, Model 4000 (P010030/S196) | Zoll Manufacturing Corporation | 2025-08-13 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S013) | Bard Peripheral Vascular, Inc. | 2025-08-13 |
| Avive Automated External Defibrillator (AED) System (P210015/S007) | Avive Solutions, Inc. | 2025-08-13 |
| Protege RX Carotid Stent System (P060001/S051) | Medtronic Vascular, Inc. | 2025-08-13 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1;Brav (P010031/S900) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Srome MRI ICD (P980016/S932) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S898) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CR T- (P010015/S568) | Medtronic, Inc. | 2025-08-12 |
| Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (P980016/S934) | Medtronic Cardiac Rhythm Disease Management | 2025-08-12 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S099) | Medtronic, Inc. | 2025-08-12 |
| Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S214) | Medtronic, Inc. | 2025-08-12 |
| Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED (P980035/S820) | Medtronic, Inc. | 2025-08-12 |
| Aurora EV ICD DVEA3E4 (P220012/S056) | Medtronic, Inc. | 2025-08-12 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S044) | Medtronic Vascular, Inc. | 2025-08-12 |
| Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Se (P010015/S569) | Medtronic, Inc. | 2025-08-12 |
| FARAPULSE Pulsed Field Ablation System (P230030/S015) | Farapulse, Inc. | 2025-08-12 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S818) | Medtronic, Inc. | 2025-08-12 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S097) | Medtronic, Inc. | 2025-08-12 |
| CareLink SmartSync Device Manager Base (P890003/S482) | Medtronic, Inc. | 2025-08-12 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S013) | ABBOTT MEDICAL | 2025-08-08 |
| Impella CP with SmartAssist System (P140003/S124) | Abiomed, Inc. | 2025-08-08 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S066) | Boston Scientific Corp | 2025-08-08 |
| lnnova Vascular Self Expanding Stent (P140028/S083) | Boston Scientific Corporation | 2025-08-08 |
| Epic Vascular Self-Expanding Stent System (P110035/S074) | Boston Scientific Corp | 2025-08-08 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S021) | ABBOTT MEDICAL | 2025-08-07 |
| VARIPULSE Platform; VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump (P240006/S010) | Biosense Webster, Inc. | 2025-08-07 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S059) | Medinol, Ltd. | 2025-08-07 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S201) | W. L. Gore & Associates, Inc. | 2025-08-07 |
| Angio-Seal Vascular Closure Device (P930038/S106) | Terumo Medical Corporation | 2025-08-07 |
| Consulta CRT-P (C4TR01); Syncra CRT-P (C2TR01) (P010015/S567) | Medtronic, Inc. | 2025-08-06 |
| Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01) (P980035/S817) | Medtronic, Inc. | 2025-08-06 |
| Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020/S007) | Sirtex Medical, Inc. | 2025-08-05 |
| EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) (P110023/S056) | Medtronic Vascular, Inc. | 2025-08-05 |
| Embrace(TM) Hydrogel Embolic System (P250003) | Instylla, Inc. | 2025-08-05 |
| MANTA Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L (P180025/S014) | Teleflex Medical, LLC | 2025-08-05 |
| MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System (P140002/S029) | Terumo Medical Corporation | 2025-08-05 |
| Avant VR (CDVRA700Q, CDVRA700T); Neutrino NxT VR (CDVRA800Q, CDVRA800T CDVRA600Q, CDVRA600T); Gallant VR (CDVRA500Q, (P910023/S481) | ABBOTT MEDICAL | 2025-08-04 |
| Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); (P030054/S438) | ABBOTT MEDICAL | 2025-08-04 |
| Impella 5.5 with SmartAssist System; Impella CP with SmartAssist System; Impella 2.5; Impella 5.0; Impella LD; (P140003/S123) | Abiomed, Inc. | 2025-08-01 |
| AFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG) (P240013/S008) | Medtronic, Inc. | 2025-08-01 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S020) | ABBOTT MEDICAL | 2025-08-01 |
| AngioJet Thrombectomy System (P980037/S095) | Boston Scientific Corp | 2025-08-01 |
| Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System; (P170011/S056) | Abiomed, Inc. | 2025-08-01 |
| Thoraflex Hybrid (P210006/S013) | Vascutek, Ltd. | 2025-07-30 |
| Epic Plus Stented Tissue Valve; Epic Max Stented Tissue Valve (P040021/S059) | ABBOTT MEDICAL | 2025-07-29 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S213) | Medtronic, Inc. | 2025-07-29 |
| Aurora EV-ICD System (P220012/S055) | Medtronic, Inc. | 2025-07-29 |
| Evera MRI DF-1 ICD (DDMB1D1, DVMB1D1, DVMC3D1); Evera MRI DF-1 ICD(DDMC3D1); Evera MRI ICD (DDMB1D4); Evera MRI ICD (DDM (P980016/S933) | Medtronic Cardiac Rhythm Disease Management | 2025-07-29 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S899) | Medtronic Cardiac Rhythm Disease Management | 2025-07-29 |
| Tendyne Transcatheter Mitral Valve (P240042/S001) | ABBOTT MEDICAL | 2025-07-29 |
| Navitor Transcatheter Aortic Valve (P190023/S026) | ABBOTT MEDICAL | 2025-07-29 |
| Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap (P980035/S819) | Medtronic, Inc. | 2025-07-29 |
| CardioMEMS HF System (P100045/S083) | ABBOTT MEDICAL | 2025-07-28 |
| Stylets Models 6053, 6054, 6055 (P960004/S107) | Boston Scientific | 2025-07-28 |
| Impella RP, Impella RP with SmartAssist, and Impella RP Flex with SmartAssist (P170011/S059) | Abiomed, Inc. | 2025-07-25 |
| Protege RX Carotid Stent System; Protege GPS Self-Expanding Peripheral Stent System (P060001/S050) | Medtronic Vascular, Inc. | 2025-07-25 |
| EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S060) | Medtronic Vascular, Inc. | 2025-07-25 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S012) | ABBOTT MEDICAL | 2025-07-25 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD (P140003/S128) | Abiomed, Inc. | 2025-07-25 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S024) | Edwards Lifesciences, LLC | 2025-07-25 |
| AED Plus and Fully Automatic AED Plus (P160015/S024) | ZOLL Medical Corporation | 2025-07-24 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S052) | Berlin Heart, Inc. | 2025-07-24 |
| Edwards EVOQUE tricuspid delivery system (P230013/S017) | Edwards Lifesciences, LLC | 2025-07-23 |
| MynxGrip Vascular Closure Device (5F, 6F/7F); Mynx Control Vascular Closure Device (5F, 6F/7F); Mynx Control Venous Vasc (P040044/S110) | Cordis US Corporation | 2025-07-23 |
| VEGA R45; VEGA R52; VEGA R58; VEGA R45 RE-INTERVENTION KIT; VEGA R58 RE-INTERVENTION KIT; VEGA R45 RE-INTERVENTION KIT (P130010/S004) | MicroPort CRM USA, Inc. | 2025-07-23 |
| HexaFlow Irrigation Pumo AFR-00004, HexaGen TM RF Generator AFR-00005, HexaPulse TM PF Generator AFR-00008 (P240013/S014) | Medtronic, Inc. | 2025-07-23 |
| Platinium VR 1210, Platinium VR 1240, ENERGYA VR 3110, TALENTIA VR 3210, ENERGYA VR 3140, TALENTIA VR 3240, Platinium DR (P980049/S147) | MicroPort CRM USA, Inc. | 2025-07-23 |
| VARIPULSE Platform (P240006/S009) | Biosense Webster, Inc. | 2025-07-23 |
| Platinium CRT-D 1711; Platinium CRT-D 1741; Platinium 4LV CRT-D 1744; ENERGYA CRT-D 3711; ENERGYA CRT-D 3741; ENERGYA 4L (P060027/S107) | MicroPort CRM USA, Inc. | 2025-07-23 |
| MitraClip G5 Delivery System (P100009/S077) | ABBOTT MEDICAL | 2025-07-23 |
| Reply SR; Reply DR; ALIZEA SR 1300; ALIZEA DR 1600; CELEA SR 1100; CELEA DR 1400 (P950029/S134) | MicroPort CRM USA, Inc. | 2025-07-23 |