| Assurity, Assurity +, Endurity, Endurity Core (P880086/S328) | ABBOTT MEDICAL | 2023-05-01 |
| Assurity MRI, Endurity MRI (P140033/S079) | ABBOTT MEDICAL | 2023-05-01 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP, Quadra Allure MP RF (P030035/S194) | ABBOTT MEDICAL | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P030005/S230) | Guidant Corp. | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (N970003/S285) | Boston Scientific Corp | 2023-05-01 |
| Ellipse DR, Ellipse VR (P910023/S453) | ABBOTT MEDICAL | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P010012/S569) | Boston Scientific Corp | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P110042/S184) | Boston Scientific Corporation | 2023-05-01 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S092) | ABBOTT MEDICAL | 2023-04-29 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S054) | ABBOTT MEDICAL | 2023-04-29 |
| CardioMEMS HF System (P100045/S065) | ABBOTT MEDICAL | 2023-04-28 |
| Preveleak Surgical Sealant (P100030/S017) | Baxter Healthcare Corporation | 2023-04-28 |
| Medtronic Core Valve Evolut R Transcatheter Aortic Valve, Medtronic Core Valve Evolut Pro Transcatheter Aortic Valve (P130021/S137) | Medtronic, Inc. | 2023-04-28 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S206) | Boston Scientific Corp | 2023-04-27 |
| Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S131) | Medtronic Cryocath, LP | 2023-04-27 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS (P150048/S071) | Edwards Lifesciences, LLC | 2023-04-27 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S075) | Boston Scientific Corp | 2023-04-27 |
| Impella RP, Impella RP with Smart Assist, Impella $.0/LD (P170011/S049) | Abiomed, Inc. | 2023-04-27 |
| EDWARDS INTUITY Elite Valve System (P150036/S069) | Edwards Lifesciences, LLC | 2023-04-27 |
| Blazer II Cardiac Ablation System (P920047/S130) | Boston Scientific Corp | 2023-04-27 |
| Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I (P020025/S138) | Boston Scientific | 2023-04-27 |
| Chilli II Cooled RF Ablation System (P980003/S095) | Boston Scientific Corp | 2023-04-27 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar (P860057/S212) | Edwards Lifesciences, LLC | 2023-04-27 |
| Impella 2.5, Impella CP and CP with SmartAssist (P140003/S110) | Abiomed, Inc. | 2023-04-27 |
| HeartWare® Ventricular Assist System (P100047/S209) | Medtronic | 2023-04-26 |
| Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System (P190023/S014) | ABBOTT MEDICAL | 2023-04-26 |
| Medtronic CoreValve EnVeo PRO Loading System, Medtronic Evolut PRO+ Loading System, Medtronic Evolut FX Loading Syst (P130021/S133) | Medtronic, Inc. | 2023-04-26 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S137) | Boston Scientific Corp | 2023-04-26 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S155) | Edwards Lifesciences, LLC | 2023-04-26 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S037) | Edwards Lifesciences, LLC | 2023-04-26 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S744) | Medtronic, Inc. | 2023-04-26 |
| Medtronic Evolut FX Delivery Catheter System (P130021/S134) | Medtronic, Inc. | 2023-04-25 |
| Artegraft Collagen Vascular Graft (N16837/S030) | LeMaitre Vascular, Inc. | 2023-04-25 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S038) | W. L. Gore & Associates, Inc. | 2023-04-24 |
| LATITUDE NXT Release 7.3 (P910077/S191) | Boston Scientific | 2023-04-21 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S140) | Boston Scientific | 2023-04-21 |
| INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S228) | Guidant Corp. | 2023-04-21 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (N970003/S283) | Boston Scientific Corp | 2023-04-21 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S490) | Boston Scientific | 2023-04-21 |
| EMBLEM S-ICD (P110042/S178) | Boston Scientific Corporation | 2023-04-21 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S567) | Boston Scientific Corp | 2023-04-21 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S046) | Cordis US Corporation | 2023-04-20 |
| Micra VR2 Transcatheter Pacing System, Micra AV2 Transcatheter Pacing System, Micra VR2/AV2 Application Software (P150033/S161) | Medtronic, Inc. | 2023-04-20 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S021) | Cordis US Corporation | 2023-04-20 |
| CareLink Instruments & DDMA, CareLink SmartSync Common Application (P890003/S457) | Medtronic, Inc. | 2023-04-20 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath (P130021/S136) | Medtronic, Inc. | 2023-04-19 |
| Rotablatorand ROTAPRO Rotational Atherectomy System (P900056/S205) | Boston Scientific Corp | 2023-04-19 |
| INGEVITY MRI, INGEVITY+ (P150012/S139) | Boston Scientific | 2023-04-19 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System, (P160043/S067) | Medtronic Vascular | 2023-04-18 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S020) | Boston Scientific Corporation | 2023-04-18 |
| LIFEPAK CR® Plus defibrillator; LIFEPAK EXPRESS® defibrillator; LIFEPAK 1000® defibrillator (P160026/S038) | Physio-Control, Inc. | 2023-04-18 |
| LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and LIFEPAK 1000® defibrillator (P160012/S007) | Physio-Control, Inc. | 2023-04-18 |
| TactiSys Quartz Equipment (P130026/S083) | St Jude Medical | 2023-04-17 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S326) | ABBOTT MEDICAL | 2023-04-14 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S405) | ABBOTT MEDICAL | 2023-04-14 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S192) | ABBOTT MEDICAL | 2023-04-14 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and (P910023/S451) | ABBOTT MEDICAL | 2023-04-14 |
| Aveir VR Leadless Pacemaker (P150035/S004) | ABBOTT MEDICAL | 2023-04-14 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S077) | ABBOTT MEDICAL | 2023-04-14 |
| Microny family of Pacemakers (P970013/S092) | ABBOTT MEDICAL | 2023-04-14 |
| PSW 2301.U, NEO 2301.U (P000009/S102) | Biotronik, Inc. | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P070008/S146) | Biotronik, Inc. | 2023-04-13 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, (P130021/S135) | Medtronic, Inc. | 2023-04-13 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM, R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P140002/S024) | Terumo Medical Corporation | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P950037/S246) | Biotronik, Inc. | 2023-04-13 |
| PSW 2301.U, NEO 2301.U (P050023/S173) | Biotronik, Inc. | 2023-04-13 |
| Impella CP with SmartAssist (P140003/S109) | Abiomed, Inc. | 2023-04-13 |
| 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, Compia (P010031/S817) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| 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/S743) | Medtronic, Inc. | 2023-04-12 |
| 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/S819) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S517) | Medtronic, Inc. | 2023-04-12 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S084) | Syncardia Systems, LLC | 2023-04-12 |
| 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/S850) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| Micra AV TPS, Micra TPS (P150033/S167) | Medtronic, Inc. | 2023-04-12 |
| 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/S853) | Medtronic Cardiac Rhythm Disease Management | 2023-04-12 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S005) | Cook Ireland, Ltd. | 2023-04-10 |
| Synergy II Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Synergy Megatron Everolimus-Eluting Platinum C (P150003/S094) | Boston Scientific Corporation | 2023-04-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S052) | Boston Scientific Corp | 2023-04-10 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter OTW, Ranger Paclitaxel-Coated PTA Balloon Catheter SL (P190019/S019) | Boston Scientific Corporation | 2023-04-10 |
| Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Promus Premier Everolimus-Eluting Platinum C (P110010/S210) | Boston Scientific Corp | 2023-04-10 |
| Consulta CRT-P, Syncra CRT-P (P010015/S516) | Medtronic, Inc. | 2023-04-07 |
| Alto Abdominal Stent Graft System (P120006/S042) | Endologix, LLC | 2023-04-07 |
| MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM, R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM (P140002/S025) | Terumo Medical Corporation | 2023-04-07 |
| Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut (P210014/S002) | Advanced Bifurcation Systems, Inc. | 2023-04-06 |
| XIENCE PROS Everolimus Eluting Coronary Stent System (P110019/S123) | Abbott Vascular | 2023-04-05 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S148) | Biotronik, Inc. | 2023-04-04 |
| Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie (P950037/S248) | Biotronik, Inc. | 2023-04-04 |
| Edwards Commander Delivery System (P200015/S029) | Edwards Lifesciences, LLC | 2023-04-04 |
| Edwards Commander Delivery System (P140031/S146) | Edwards Lifesciences, LLC | 2023-04-04 |
| Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020) | Sirtex Medical, Inc. | 2023-04-04 |
| Plexa S 60, Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa SD 60/16, Plexa ProMRI SD 60/16, Plexa ProMRI (P980023/S120) | Biotronik, Inc. | 2023-04-04 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S019) | Philips Medical Systems, Inc. | 2023-04-03 |
| VenaSeal Closure System (P140018/S033) | Medtronic Vascular, Inc. | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| Impella RP Flex with SmartAssist (P170011/S048) | Abiomed, Inc. | 2023-03-31 |
| Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) (P810002/S118) | ABBOTT MEDICAL | 2023-03-31 |
| Edwards Commander Delivery System (P140031/S154) | Edwards Lifesciences, LLC | 2023-03-30 |
| Edwards Commander Delivery System (P200015/S036) | Edwards Lifesciences, LLC | 2023-03-30 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S053) | ABBOTT MEDICAL | 2023-03-30 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S058) | Boston Scientific Corp | 2023-03-29 |