| Zilver Vena® Venous Self Expanding Stent (P200023/S003) | Cook Ireland, Ltd. | 2023-02-22 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S033) | Edwards Lifesciences, LLC | 2023-02-22 |
| Zilver® Vascular Stent (P050017/S020) | Cook Ireland, Ltd. | 2023-02-22 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S007) | Kestra Medical Technologies, Inc. | 2023-02-21 |
| EMBLEM S-ICD, EMBLEM MRI S-ICD, (P110042/S180) | Boston Scientific Corporation | 2023-02-21 |
| Ellipse, Fortify, Fortify Assura, Quadra Assura MP (P910023/S449) | ABBOTT MEDICAL | 2023-02-21 |
| Quadra Assura, Unify, Unify Assura, Unify Quadra (P030054/S403) | ABBOTT MEDICAL | 2023-02-21 |
| R Series MCU 20.01 software release (P160022/S032) | ZOLL Medical Corporation | 2023-02-17 |
| Sprint Quattro Lead (P920015/S275) | Medtronic, Inc. | 2023-02-17 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S032) | Berlin Heart, Inc. | 2023-02-17 |
| Fluency Endovascular Stent Graft (P130029/S012) | Bard Peripheral Vascular, Inc. | 2023-02-17 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S212) | Medtronic Cardiac Rhythm Disease Management | 2023-02-17 |
| M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge (P160029/S018) | Philips Medical Systems, Inc. | 2023-02-16 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S053) | Boston Scientific Corp | 2023-02-16 |
| Innova Self-Expanding Stent System (P140028/S076) | Boston Scientific Corporation | 2023-02-16 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S741) | Medtronic, Inc. | 2023-02-16 |
| HeartMate 3 Left Ventricular Assist System (P160054/S052) | ABBOTT MEDICAL | 2023-02-16 |
| QUIK-PAK Electrodes (P160012/S005) | Physio-Control, Inc. | 2023-02-15 |
| Harmony Delivery Catheter System (P200046/S014) | Medtronic, Inc. | 2023-02-15 |
| HeartWare HVAD System (P100047/S207) | Medtronic | 2023-02-15 |
| INTUITY Delivery System - Accessories (P150036/S067) | Edwards Lifesciences, LLC | 2023-02-14 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S095) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S093) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S006) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S172) | Biotronik, Inc. | 2023-02-13 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S194) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S156) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| HeartWare Ventricular Assist System (P100047/S204) | Medtronic | 2023-02-13 |
| Cordis® EXOSEAL® Vascular Closure Device (P100013/S025) | Cordis US Corporation | 2023-02-13 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S133) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| Harmony Transcatheter Pulmonary Valve, Harmony Delivery Catheter System (P200046/S015) | Medtronic, Inc. | 2023-02-12 |
| Allure, Allure Quadra, Quadra Allure, Quadra Allure MP (P030035/S193) | ABBOTT MEDICAL | 2023-02-10 |
| Fortify, Fortify Assura, Ellipse, Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avan (P910023/S450) | ABBOTT MEDICAL | 2023-02-10 |
| Unify ,Unify Assura, Quadra Assura, Quadra Assura MP, Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Neutrino NxT (P030054/S404) | ABBOTT MEDICAL | 2023-02-10 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S452) | ABBOTT MEDICAL | 2023-02-10 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S406) | ABBOTT MEDICAL | 2023-02-10 |
| Assurity MRI, Endurity MRI, (P140033/S078) | ABBOTT MEDICAL | 2023-02-10 |
| Assurity, Assurity+, Endurity (P880086/S327) | ABBOTT MEDICAL | 2023-02-10 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S099) | Terumo Medical Corporation | 2023-02-09 |
| Evera S, Evera XT, Maximo II, Protecta, Protecta XT, Secura, Virtuoso II, Cobalt, Cobalt XT, Crome, Crome XT (P980016/S842) | Medtronic Cardiac Rhythm Disease Management | 2023-02-08 |
| Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad C, Viva Quad S, Viva Quad XT, Viva (P010031/S809) | Medtronic Cardiac Rhythm Disease Management | 2023-02-08 |
| Instrument Command Library (ICL), Device Command Library (DCL) (P890003/S459) | Medtronic, Inc. | 2023-02-08 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S013) | Great Batch Medical | 2023-02-07 |
| TRIDYNE Vascular Sealant (P150016/S023) | Neomend, Inc. | 2023-02-07 |
| Portico (P190023/S012) | ABBOTT MEDICAL | 2023-02-07 |
| Attain StarFix Lead (P060039/S113) | Medtronic, Inc. | 2023-02-06 |
| 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, Cobalt (P010031/S814) | Medtronic Cardiac Rhythm Disease Management | 2023-02-06 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S848) | Medtronic Cardiac Rhythm Disease Management | 2023-02-06 |
| 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/S740) | Medtronic, Inc. | 2023-02-06 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S174) | Medtronic, Inc. | 2023-02-06 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S515) | Medtronic, Inc. | 2023-02-06 |
| Consulta CRT-P, Percepta Bioplar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S514) | Medtronic, Inc. | 2023-02-06 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S739) | Medtronic, Inc. | 2023-02-03 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S847) | Medtronic Cardiac Rhythm Disease Management | 2023-02-03 |
| Consulta CRT-P, Syncra CRT-P (P010015/S513) | Medtronic, Inc. | 2023-02-03 |
| 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, Cobalt (P010031/S813) | Medtronic Cardiac Rhythm Disease Management | 2023-02-03 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac (P200039/S009) | Shockwave Medical, Inc. | 2023-02-02 |
| LifeStent 5F Vascular Stent Systems (P070014/S064) | Bard Peripheral Vascular, Inc. | 2023-02-02 |
| HeartWare® Ventricular Assist System, HeartWare® System (P100047/S205) | Medtronic | 2023-02-02 |
| Venovo Venous Stent System (P180037/S012) | Bard Peripheral Vascular, Inc. | 2023-02-02 |
| Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S204) | Boston Scientific Corp | 2023-02-02 |
| Synergy XD Everolimus-Eluting Platinum Chromium Coronary Stent System, Synergy Megatron Everolimus-Eluting Platinum Chro (P150003/S088) | Boston Scientific Corporation | 2023-02-01 |
| Medtronic CoreValue Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt (P130021/S130) | Medtronic, Inc. | 2023-02-01 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S035) | Boston Scientific Corp | 2023-02-01 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S023) | Abbott Vascular, Inc. | 2023-01-31 |
| XACT Carotid Stent System (P040038/S041) | Abbott Vascular, Inc. | 2023-01-31 |
| Supera Peripheral Stent System (P120020/S030) | Abbott Vascular (Idef Technologies Inc) | 2023-01-31 |
| MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S051) | ABBOTT MEDICAL | 2023-01-31 |
| RX Acculink Carotid Stent System (P040012/S064) | Abbott Vascular | 2023-01-31 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System, Prostar X (P960043/S120) | Abbott Vascular, Inc. | 2023-01-31 |
| StarClose SE Vascular Closure System (P050007/S043) | Abbott Vascular Devices | 2023-01-31 |
| LifeVest® Wearable Defibrillator (P010030/S161) | Zoll Manufacturing Corporation | 2023-01-30 |
| Evolut FX Delivery Catheter System (P130021/S131) | Medtronic, Inc. | 2023-01-29 |
| Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield graft technology (C (P810002/S116) | ABBOTT MEDICAL | 2023-01-27 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, E (P980016/S846) | Medtronic Cardiac Rhythm Disease Management | 2023-01-26 |
| ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S025) | Biotronik AG | 2023-01-26 |
| 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, Cobalt (P010031/S812) | Medtronic Cardiac Rhythm Disease Management | 2023-01-26 |
| Artegraft Collagen Vascular Graft (N16837/S029) | LeMaitre Vascular, Inc. | 2023-01-25 |
| SmartAblate Irrigation Tubing Set (P990071/S055) | Biosense Webster, Inc. | 2023-01-24 |
| RelayPlus Thoracic Stent-Graft System (P110038/S027) | Bolton Medical, Inc. | 2023-01-20 |
| TREO® Abdominal Stent-Graft System (P190015/S010) | Bolton Medical, Inc. | 2023-01-20 |
| Pamira ICD Leads (P980023/S113) | Biotronik, Inc. | 2023-01-20 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S053) | Boston Scientific Corp | 2023-01-20 |
| BAROSTIM NEO® System (P180050/S008) | Cvrx, Inc. | 2023-01-20 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S056) | Boston Scientific Corp | 2023-01-20 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S151) | Edwards Lifesciences, LLC | 2023-01-20 |
| LifeVest® Wearable Defibrillator (P010030/S163) | Zoll Manufacturing Corporation | 2023-01-19 |
| Arctic Front Advance® Cardiac CryoAblation Catheters (P100010/S134) | Medtronic Cryocath, LP | 2023-01-19 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter (P020045/S102) | Medtronic Cryocath, LP | 2023-01-19 |
| 9F Freezor MAX Cardiac Cryoablation Catheter (P100010/S135) | Medtronic Cryocath, LP | 2023-01-19 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S028) | Edwards Lifesciences, LLC | 2023-01-19 |
| CareLink SmartSync Micra VR App, CareLink SmartSync Micra AV App (P150033/S162) | Medtronic, Inc. | 2023-01-18 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S134) | Boston Scientific Corp | 2023-01-18 |
| LifeVest® Wearable Defibrillator (P010030/S158) | Zoll Manufacturing Corporation | 2023-01-17 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S512) | Medtronic, Inc. | 2023-01-17 |
| 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/S738) | Medtronic, Inc. | 2023-01-17 |
| RELIANCE 4-FRONT (P910073/S171) | Boston Scientific | 2023-01-16 |
| Sprint Quattro Lead (P920015/S274) | Medtronic, Inc. | 2023-01-16 |
| CapSure Sense Lead (P830061/S211) | Medtronic Cardiac Rhythm Disease Management | 2023-01-16 |