| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S402) | ABBOTT MEDICAL | 2022-09-09 |
| NAVISTAR (P990025/S069) | Biosense Webster, Inc. | 2022-09-09 |
| 8mm Dual Sensor (DS) Catheters (P010068/S069) | Biosense Webster, Inc. | 2022-09-09 |
| NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) (P040036/S089) | Biosense Webster, Inc. | 2022-09-09 |
| Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi (P150048/S065) | Edwards Lifesciences, LLC | 2022-09-08 |
| HeartWare HVAD System (P100047/S200) | Medtronic | 2022-09-08 |
| Omnilink Elite Vascular Balloon-Exoandable Stent System (P110043/S013) | Abbott Vascular-Cardiac Therapies | 2022-09-07 |
| MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK VISION RX 2.75 mm Coronary Stent System, MULTI-LINK MINI VISION (P020047/S075) | Abbott Vascular | 2022-09-07 |
| TRIDYNE Vascular Sealant (P150016/S022) | Neomend, Inc. | 2022-09-07 |
| MULTI-LINK RX ULTRA Coronary Stent System (P970020/S086) | Abbott Vascular, Inc. | 2022-09-07 |
| OPTIMIZER Smart System (P180036/S014) | Impulse Dynamics (Usa), Inc. | 2022-09-06 |
| Micra AV TPS and Micra TPS (P150033/S150) | Medtronic, Inc. | 2022-09-06 |
| Impella CP with SmartAssist (P140003/S105) | Abiomed, Inc. | 2022-09-06 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S067) | Medtronic, Inc. | 2022-09-02 |
| Rotablatorand ROTAPRO Rotational Atherectomy System (P900056/S200) | Boston Scientific Corp | 2022-09-02 |
| WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Devices with Delivery Systems (P130013/S043) | Boston Scientific Corp | 2022-09-02 |
| Zenith Dissection Endovascular System (P180001/S006) | William Cook Europe Aps | 2022-09-01 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro (P110010/S204) | Boston Scientific Corp | 2022-09-01 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S093) | W. L. Gore & Associates, Inc. | 2022-09-01 |
| GORE VIABAHN Endoprosthesis (P040037/S154) | W. L. Gore & Associates, Inc. | 2022-09-01 |
| CardioGenesis TMR System (P970029/S040) | Cryolife, Inc. | 2022-09-01 |
| Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 (P200039/S007) | Shockwave Medical, Inc. | 2022-09-01 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S022) | Biotronik AG | 2022-08-31 |
| GORE(R) EXCLUDER(R) AAA Endoprosthesis, GORE(R) EXCLUDER(R) Iliac Branch Endoprosthesis (P020004/S190) | W. L. Gore & Associates, Inc. | 2022-08-31 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S079) | St Jude Medical | 2022-08-31 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist (P140003/S103) | Abiomed, Inc. | 2022-08-31 |
| Impella RP, Impella RP with SmartAssist (P170011/S045) | Abiomed, Inc. | 2022-08-31 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S030) | Berlin Heart, Inc. | 2022-08-30 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S833) | Medtronic Cardiac Rhythm Disease Management | 2022-08-29 |
| INGEVITY+ Active Fixation Pace/Sense Lead (P150012/S125) | Boston Scientific | 2022-08-29 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S799) | Medtronic Cardiac Rhythm Disease Management | 2022-08-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S074) | Boston Scientific Corporation | 2022-08-29 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S050) | Boston Scientific Corp | 2022-08-29 |
| RESONATE HF, RESONATE, RESONATE X4, MOMENTUM, MOMENTUM X4, VIGILIANT, VIGILIANT X4 (P010012/S552) | Boston Scientific Corp | 2022-08-26 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S727) | Medtronic, Inc. | 2022-08-26 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Solara Bipolar CRT-P, Solara Q (P010015/S505) | Medtronic, Inc. | 2022-08-26 |
| Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead (P920015/S270) | Medtronic, Inc. | 2022-08-26 |
| CapSureFix Novus MRI SureScan Lead Models 4076 and 5076 (P930039/S244) | Medtronic, Inc. | 2022-08-26 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S100) | Terumo Medical Corporation | 2022-08-26 |
| RESONATE HF, RESONATE EL, MOMENTUM EL, VIGILIANT EL, PERCIVA HF, PERCIVA (P960040/S476) | Boston Scientific | 2022-08-26 |
| Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG (P980035/S721) | Medtronic, Inc. | 2022-08-26 |
| Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E (P980016/S825) | Medtronic Cardiac Rhythm Disease Management | 2022-08-26 |
| CapSureFix MRI SureScan Lead Model 5086MRI (P090013/S323) | Medtronic, Inc. | 2022-08-26 |
| Express® LD Iliac Premounted Stent System (P090003/S052) | Boston Scientific Corporation | 2022-08-25 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S800) | Medtronic Cardiac Rhythm Disease Management | 2022-08-25 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S834) | Medtronic Cardiac Rhythm Disease Management | 2022-08-25 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S031) | Berlin Heart, Inc. | 2022-08-24 |
| GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S092) | W. L. Gore & Associates, Inc. | 2022-08-24 |
| Freezor TM Cardiac Cryoablation Catheter (P020045/S101) | Medtronic Cryocath, LP | 2022-08-24 |
| Artic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S129) | Medtronic Cryocath, LP | 2022-08-24 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S726) | Medtronic, Inc. | 2022-08-23 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S117) | Abbott Vascular, Inc. | 2022-08-23 |
| LifeStream® Balloon Expandable Vascular Covered Stent (P160024/S012) | Bard Peripheral Vascular, Inc. | 2022-08-23 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S138) | Biotronik, Inc. | 2022-08-22 |
| 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, Enticos (P950037/S237) | Biotronik, Inc. | 2022-08-22 |
| ENROUTE Transcarotid Stent System (P140026/S023) | Boston Scientific Corporation | 2022-08-19 |
| Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist (P170011/S043) | Abiomed, Inc. | 2022-08-19 |
| ELCA Coronoary Laser Atherectomy Catheter (P910001/S116) | Spectranetics Corp. | 2022-08-19 |
| LifeVest® Wearable Defibrillator (P010030/S160) | Zoll Manufacturing Corporation | 2022-08-18 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S102) | Abiomed, Inc. | 2022-08-18 |
| OPTIMIZER Smart, OPTIMIZER Smart Mini (P180036/S015) | Impulse Dynamics (Usa), Inc. | 2022-08-18 |
| PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS ELITE Everolimus-Eluting Platinum Chro (P110010/S201) | Boston Scientific Corp | 2022-08-18 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S077) | St Jude Medical | 2022-08-17 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S105) | Medtronic Vascular | 2022-08-16 |
| MitraClip G4 Clip Delivery System (P100009/S046) | ABBOTT MEDICAL | 2022-08-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S832) | Medtronic Cardiac Rhythm Disease Management | 2022-08-16 |
| Micra AV TPS, Micra TPS (P150033/S149) | Medtronic, Inc. | 2022-08-16 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S009) | W. L. Gore and Associates, Inc. | 2022-08-16 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S798) | Medtronic Cardiac Rhythm Disease Management | 2022-08-16 |
| QUIK-COMBO® Therapy Cable (P160026/S033) | Physio-Control, Inc. | 2022-08-16 |
| EPi-Sense® ST Guided Coagulation System (P200002/S002) | AtriCure, Inc. | 2022-08-16 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S028) | Berlin Heart, Inc. | 2022-08-12 |
| RelayPlus Thoracic Stent-Graft System (P110038/S026) | Bolton Medical, Inc. | 2022-08-11 |
| RelayPro Thoracic Stent-Graft System (P200045/S003) | Bolton Medical, Inc. | 2022-08-11 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S725) | Medtronic, Inc. | 2022-08-09 |
| Consulta CRT-P, Syncra CRT-P (P010015/S504) | Medtronic, Inc. | 2022-08-09 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S797) | Medtronic Cardiac Rhythm Disease Management | 2022-08-08 |
| MitraClip G4 Clip Delivery System (P100009/S045) | ABBOTT MEDICAL | 2022-08-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S831) | Medtronic Cardiac Rhythm Disease Management | 2022-08-08 |
| Thoraflex Hybrid (P210006/S001) | Vascutek, Ltd. | 2022-08-08 |
| Edwards Alterra Adaptive Prestent System (P200015/S020) | Edwards Lifesciences, LLC | 2022-08-08 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S030) | Physio-Control, Inc. | 2022-08-05 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S026) | Biotronik AG | 2022-08-05 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S003) | W. L. Gore & Associates, Inc. | 2022-08-05 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S027) | Berlin Heart, Inc. | 2022-08-04 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System (P130021/S119) | Medtronic, Inc. | 2022-08-03 |
| Avalus (P170006/S021) | Medtronic, Inc. | 2022-08-03 |
| Medtronic Harmony Transcatheter Pulmonary Valve System (P200046/S010) | Medtronic, Inc. | 2022-08-03 |
| Melody Transcatheter Pulmonary Valve (P140017/S022) | Medtronic, Inc. | 2022-08-03 |
| OptiSense, Tendril STS, Tendril SDX, Tendril ST (P960013/S121) | ABBOTT MEDICAL | 2022-08-01 |
| Tendril MRI (P140033/S074) | ABBOTT MEDICAL | 2022-08-01 |
| Quickflex µ, Quartet (P030054/S400) | ABBOTT MEDICAL | 2022-08-01 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve (P150048/S066) | Edwards Lifesciences, LLC | 2022-08-01 |
| Portico Transcatheter Aortic Valve Implantation System (P190023/S009) | ABBOTT MEDICAL | 2022-08-01 |
| IsoFlex (P960030/S076) | ABBOTT MEDICAL | 2022-08-01 |
| Durata, Optisure (P950022/S143) | ABBOTT MEDICAL | 2022-08-01 |
| On- X Prosthetic Heart Valve, Ascending Aortic Prothesis (P000037/S060) | On-X Life Technologies, Inc. | 2022-08-01 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S051) | Boston Scientific Corp | 2022-07-29 |
| Orchestra, Orchestra Plus, and SmartTouch programming software modules (P980049/S143) | MicroPort CRM USA, Inc. | 2022-07-28 |
| GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) (P020004/S189) | W. L. Gore & Associates, Inc. | 2022-07-28 |