| MitraClip Clip Delivery System (P100009/S056) | ABBOTT MEDICAL | 2023-06-29 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S084) | St Jude Medical | 2023-06-29 |
| Scoreflex NC (P200041/S001) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2023-06-29 |
| INGEVITY MRI Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead, INGEVITY+ Pace/Sense Lead (P150012/S146) | Boston Scientific | 2023-06-29 |
| Artegraft Collagen Vascular Graft (N16837/S031) | LeMaitre Vascular, Inc. | 2023-06-29 |
| FINELINE®II EZ Sterox Bipolar IS-1 Atrial/Ventricular, J shaped Lead Stylets Limber, J shaped Lead Stylets Firm, J shape (P960004/S102) | Boston Scientific | 2023-06-29 |
| Aveir DR Leadless System (P150035/S003) | ABBOTT MEDICAL | 2023-06-29 |
| Pacemaker/ICD/CRT non-implanted components (P050023/S171) | Biotronik, Inc. | 2023-06-28 |
| Organ Care System (OCS) Heart (P180051/S004) | TransMedics, Inc. | 2023-06-28 |
| Pacemaker/ICD/CRT nonimplanted components (P000009/S101) | Biotronik, Inc. | 2023-06-28 |
| Permanent Defibrillator Electrodes (P980023/S121) | Biotronik, Inc. | 2023-06-28 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S249) | Biotronik, Inc. | 2023-06-28 |
| Defibrillator, Implantable, Dual- Chamber, Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchroniza (P050023/S175) | Biotronik, Inc. | 2023-06-28 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P950037/S244) | Biotronik, Inc. | 2023-06-28 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S149) | Biotronik, Inc. | 2023-06-28 |
| Pacemaker/ICD/CRT non-implanted components (P070008/S144) | Biotronik, Inc. | 2023-06-28 |
| Impella CP with SmartAssist (P140003/S112) | Abiomed, Inc. | 2023-06-27 |
| Impella RP Flex with SmartAssist (P170011/S050) | Abiomed, Inc. | 2023-06-23 |
| HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (P200007) | Graphic Controls D.B.A. Vermed | 2023-06-23 |
| HeartMate 3 Left Ventricular Assist System (P160054/S055) | ABBOTT MEDICAL | 2023-06-22 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S012) | Edwards Lifesciences, LLC | 2023-06-22 |
| Zoll OneStep CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy (P160022/S015) | ZOLL Medical Corporation | 2023-06-21 |
| HeartWare® Ventricular Assist System, HeartWare® System (P100047/S210) | Medtronic | 2023-06-21 |
| DiamondTemp Irrigation Tubing Set (P200028/S018) | Medtronic, Inc. | 2023-06-21 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S009) | W. L. Gore & Associates, Inc. | 2023-06-20 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S012) | W. L. Gore and Associates, Inc. | 2023-06-20 |
| Conformable GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S135) | W. L. Gore & Associates, Inc. | 2023-06-20 |
| Adapta, Versa, Sensia IPG (P980035/S749) | Medtronic, Inc. | 2023-06-20 |
| LifeVest® Wearable Defibrillator (P010030/S166) | Zoll Manufacturing Corporation | 2023-06-20 |
| SurVeil Drug-Coated Balloon (P210025) | Surmodics,Inc. | 2023-06-16 |
| ENROUTE® Transcarotid Stent System (P140026/S024) | Boston Scientific Corporation | 2023-06-16 |
| Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r (P200039/S012) | Shockwave Medical, Inc. | 2023-06-15 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S454) | ABBOTT MEDICAL | 2023-06-15 |
| EMBLEM S-ICD Programmer Software Application, EMBLEM S-ICD Pulse Generator, EMBLEM MRI S-ICD Pulse Generator (P110042/S181) | Boston Scientific Corporation | 2023-06-15 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S407) | ABBOTT MEDICAL | 2023-06-15 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems/ Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems (P160043/S070) | Medtronic Vascular | 2023-06-15 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S029) | Biotronik AG | 2023-06-15 |
| End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S170) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S063) | Boston Scientific Scimed, Inc. | 2023-06-14 |
| CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S216) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| CapSureFix MRI Lead (P090013/S327) | Medtronic, Inc. | 2023-06-14 |
| CapSure Epicardial Pacing Lead (P950024/S106) | Medtronic, Inc. | 2023-06-14 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S176) | Medtronic, Inc. | 2023-06-14 |
| Adapta, Versa, Sensia IPG (P980035/S751) | Medtronic, Inc. | 2023-06-14 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S143) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S062) | Boston Scientific Corporation | 2023-06-14 |
| StarClose SE Vascular Closure System (P050007/S044) | Abbott Vascular Devices | 2023-06-14 |
| Micra AV TPS, Micra TPS (P150033/S174) | Medtronic, Inc. | 2023-06-14 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S165) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| Transvene CS/SVC Lead (P980050/S140) | Medtronic, Inc. | 2023-06-14 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S461) | Medtronic, Inc. | 2023-06-14 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine) (P110019/S126) | Abbott Vascular | 2023-06-14 |
| Myocardial Pacing Lead (P120017/S032) | Medtronic, Inc. | 2023-06-14 |
| 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/S826) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S020) | Abbott Vascular | 2023-06-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, M (P980016/S860) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S278) | Medtronic, Inc. | 2023-06-14 |
| MULTI-LINK VISION® RX Coronary Stent System, MULTI-LINK MINI VISION® RX Coronary Stent System (P020047/S076) | Abbott Vascular | 2023-06-14 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S038) | Boston Scientific Corp | 2023-06-14 |
| Attain Bipolar OTW Lead, OTW LV Lead (P010015/S521) | Medtronic, Inc. | 2023-06-14 |
| WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S072) | Boston Scientific Corp | 2023-06-14 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S252) | Medtronic, Inc. | 2023-06-14 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S113) | Abiomed, Inc. | 2023-06-14 |
| XACT Carotid Stent System (P040038/S042) | Abbott Vascular, Inc. | 2023-06-14 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S519) | Medtronic, Inc. | 2023-06-13 |
| Evolut R TAV, Evolut PRO TAV, Evolut PRO+ TAV, Evolut FX TAV (P130021/S139) | Medtronic, Inc. | 2023-06-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S041) | Edwards Lifesciences, LLC | 2023-06-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S172) | Medtronic, Inc. | 2023-06-13 |
| 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/S823) | Medtronic Cardiac Rhythm Disease Management | 2023-06-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S158) | Edwards Lifesciences, LLC | 2023-06-13 |
| 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/S857) | Medtronic Cardiac Rhythm Disease Management | 2023-06-13 |
| Harmony TPV (P200046/S017) | Medtronic, Inc. | 2023-06-13 |
| 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/S748) | Medtronic, Inc. | 2023-06-13 |
| Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables (P010068/S071) | Biosense Webster, Inc. | 2023-06-12 |
| Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, Deflectable Diagnostic/Ablation Catheter, Celsius Catheter, (P950005/S086) | Biosense Webster, Inc. | 2023-06-12 |
| NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables (P990025/S071) | Biosense Webster, Inc. | 2023-06-12 |
| Interface Cables (P990071/S057) | Biosense Webster, Inc. | 2023-06-12 |
| ThermoCool SmartTouch Catheters, EZ Steer ThermoCool Nav Catheter, Celsius RMT ThermoCool Catheter, ThermoCool SF NAV Ca (P030031/S133) | Biosense Webster, Inc. | 2023-06-12 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY SHIELD Everolimus-Eluting Plat (P150003/S093) | Boston Scientific Corporation | 2023-06-12 |
| 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/S747) | Medtronic, Inc. | 2023-06-12 |
| EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoCool Catheter, ThermoCool SmartTouch Catheters (P040036/S095) | Biosense Webster, Inc. | 2023-06-12 |
| MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK MINI VISION Coronary Stent System (P020047/S077) | Abbott Vascular | 2023-06-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S518) | Medtronic, Inc. | 2023-06-12 |
| QDOT MICRO Catheter, Interface Cables (P210027/S003) | Biosense Webster, Inc. | 2023-06-12 |
| 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/S859) | Medtronic Cardiac Rhythm Disease Management | 2023-06-09 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S520) | Medtronic, Inc. | 2023-06-09 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S173) | Medtronic, Inc. | 2023-06-09 |
| 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/S825) | Medtronic Cardiac Rhythm Disease Management | 2023-06-09 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S750) | Medtronic, Inc. | 2023-06-09 |
| Micra AV TPS, Micra TPS (P150033/S166) | Medtronic, Inc. | 2023-06-07 |
| Zenith Dissection Endovascular System (P180001/S007) | William Cook Europe Aps | 2023-06-07 |
| DETOUR System (P220021) | Endologix, LLC | 2023-06-07 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S006) | Cook Medical Incorporated | 2023-06-07 |
| Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System, (P100040/S057) | Medtronic Vascular | 2023-06-06 |
| Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System, (P100021/S114) | Medtronic Vascular | 2023-06-06 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S822) | Medtronic Cardiac Rhythm Disease Management | 2023-06-06 |
| OPTIMZER Smart Mini IPG Firmware (P180036/S017) | Impulse Dynamics (Usa), Inc. | 2023-06-06 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S856) | Medtronic Cardiac Rhythm Disease Management | 2023-06-06 |
| Edwards Commander delivery system (Size 29mm) (P200015/S040) | Edwards Lifesciences, LLC | 2023-06-02 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S058) | Medtronic Vascular | 2023-06-02 |