| Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092) | ABBOTT MEDICAL | 2025-12-23 |
| Proclaim Spinal Cord Stimulation (SCS) System (P010032/S246) | ABBOTT MEDICAL | 2025-12-23 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S127) | ABBOTT MEDICAL | 2025-12-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S014) | ABBOTT MEDICAL | 2025-12-23 |
| Volt PFA System (P250022) | ABBOTT MEDICAL | 2025-12-19 |
| HeartMate II Left Ventricular Assist System (P060040/S122) | ABBOTT MEDICAL | 2025-12-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S116) | ABBOTT MEDICAL | 2025-12-17 |
| Durata Leads; Optisure Leads (P950022/S151) | ABBOTT MEDICAL | 2025-12-09 |
| Tendril STS Leads; Ultipace Leads (P960013/S132) | ABBOTT MEDICAL | 2025-12-09 |
| Durata Defibrillation Leads (P950022/S150) | ABBOTT MEDICAL | 2025-11-20 |
| OptiSense Pacing Leads (P960013/S131) | ABBOTT MEDICAL | 2025-11-20 |
| Quartet and QuickFlex µ Left Heart Leads (P030054/S439) | ABBOTT MEDICAL | 2025-11-20 |
| IsoFlex Pacing Leads (P960030/S083) | ABBOTT MEDICAL | 2025-11-20 |
| Tendril MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers (P140033/S100) | ABBOTT MEDICAL | 2025-11-20 |
| CardioMEMS HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) (P100045/S087) | ABBOTT MEDICAL | 2025-11-10 |
| Deep Brain Stimulation (DBS) Neurostimulation System (P140009/S124) | ABBOTT MEDICAL | 2025-11-07 |
| Spinal Cord Stimulation (SCS) Neurostimulation System (P010032/S243) | ABBOTT MEDICAL | 2025-11-07 |
| Dorsal Root Ganglion (DRG) Neurostimulation System (P150004/S090) | ABBOTT MEDICAL | 2025-11-07 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S112) | ABBOTT MEDICAL | 2025-11-04 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S023) | ABBOTT MEDICAL | 2025-10-30 |
| Epic, Epic Supra, Epic Plus, Epic Plus Supra and Epic Max Stented Tissue Valve (P040021/S060) | ABBOTT MEDICAL | 2025-10-30 |
| Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle) (P150035/S033) | ABBOTT MEDICAL | 2025-10-28 |
| Amplatzer Duct Occluder; Amplatzer Duct Occluder II; Amplatzer Piccolo Occluder (P020024/S071) | ABBOTT MEDICAL | 2025-10-23 |
| Amplatzer Muscular VSD Occluder (P040040/S050) | ABBOTT MEDICAL | 2025-10-23 |
| Amplatzer PFO Occluder; Amplatzer Talisman PFO Occluder (P120021/S027) | ABBOTT MEDICAL | 2025-10-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S013) | ABBOTT MEDICAL | 2025-10-23 |
| Amplatzer Septal Occluder; Amplatzer Multi-Fenestrated Septal Occluder - Cribriform (P000039/S083) | ABBOTT MEDICAL | 2025-10-23 |
| Esprit BTK RX System; Esprit BTK OTW System (P230036/S016) | ABBOTT MEDICAL | 2025-10-22 |
| MITRACLIP DELIVERY SYSTEM (P100009/S081) | ABBOTT MEDICAL | 2025-10-17 |
| HeartMate Apical Coring Knife (P060040/S112) | ABBOTT MEDICAL | 2025-10-17 |
| HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System (P160054/S094) | ABBOTT MEDICAL | 2025-10-17 |
| TriClip G4 System (P230007/S018) | ABBOTT MEDICAL | 2025-10-17 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S089) | ABBOTT MEDICAL | 2025-10-16 |
| Masters Series Mechanical Heart Valve (P810002/S125) | ABBOTT MEDICAL | 2025-10-15 |
| FlexNav Delivery System; Navitor Transcatheter Aortic Valves (P190023/S028) | ABBOTT MEDICAL | 2025-10-15 |
| HeartMate 3 Left Ventricular Assist System (P160054/S113) | ABBOTT MEDICAL | 2025-10-09 |
| HeartMate 3 Left Ventricular Assist System (P160054/S104) | ABBOTT MEDICAL | 2025-10-06 |
| Tendyne Transcatheter Mitral Valve System (P240042/S002) | ABBOTT MEDICAL | 2025-10-04 |
| TriClip G4 Delivery System; TriClip G5 Delivery System (P230007/S017) | ABBOTT MEDICAL | 2025-09-30 |
| AVEIR Leadless Pacemaker Real-time Clock (RTC) electrical test (P150035/S032) | ABBOTT MEDICAL | 2025-09-30 |
| MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (P100009/S080) | ABBOTT MEDICAL | 2025-09-30 |
| Infinity DBS System (P140009/S122) | ABBOTT MEDICAL | 2025-09-26 |
| Proclaim DRG System (P150004/S088) | ABBOTT MEDICAL | 2025-09-26 |
| Proclaim SCS System (P010032/S241) | ABBOTT MEDICAL | 2025-09-26 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S015) | ABBOTT MEDICAL | 2025-09-26 |
| DBS Neurostimulation System (P140009/S125) | ABBOTT MEDICAL | 2025-09-25 |
| DRG Neurostimulation System (P150004/S091) | ABBOTT MEDICAL | 2025-09-25 |
| SCS Neurostimulation System (P010032/S244) | ABBOTT MEDICAL | 2025-09-25 |
| CardioMEMS HF System (P100045/S079) | ABBOTT MEDICAL | 2025-09-24 |
| AVEIR Patient Transmitter (model, LSRM01), AVEIR Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T (P150035/S028) | ABBOTT MEDICAL | 2025-09-24 |
| Navitor Transcatheter Aortic Valve Implantation System (P190023/S027) | ABBOTT MEDICAL | 2025-09-22 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S012) | ABBOTT MEDICAL | 2025-09-18 |
| Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201 (P150035/S030) | ABBOTT MEDICAL | 2025-09-17 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S085) | ABBOTT MEDICAL | 2025-09-17 |
| CardioMEMSTM HF System (P100045/S084) | ABBOTT MEDICAL | 2025-09-10 |
| Eterna SCS IPG (P010032/S240) | ABBOTT MEDICAL | 2025-09-07 |
| Liberta RC DBS IPG (P140009/S121) | ABBOTT MEDICAL | 2025-09-07 |
| AVEIR Leadless Pacemaker (P150035/S031) | ABBOTT MEDICAL | 2025-09-05 |
| Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S242) | ABBOTT MEDICAL | 2025-08-29 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S014) | ABBOTT MEDICAL | 2025-08-29 |
| Proclaim Doral Root Ganglion (DRG) IPG (P150004/S089) | ABBOTT MEDICAL | 2025-08-29 |
| Infinity Deep Brain Stimulation (DBS) IPG (P140009/S123) | ABBOTT MEDICAL | 2025-08-29 |
| Avant DR CDDRA700Q, CDDRA700T; Gallant DR CDDRA500Q, CDDRA500T; Entrant DR CDDRA300Q, CDDRA300T; Neutrino NxT DR CDD (P910023/S479) | ABBOTT MEDICAL | 2025-08-27 |
| IsoFlex (1944) (P960030/S081) | ABBOTT MEDICAL | 2025-08-27 |
| Quartet 1456Q, 1457Q, 1458Q, 1458QL; Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant HF CDHFA500B, CDHFA (P030054/S436) | ABBOTT MEDICAL | 2025-08-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S110) | ABBOTT MEDICAL | 2025-08-27 |
| HeartMate 3 Left Ventricular Assist System (P160054/S111) | ABBOTT MEDICAL | 2025-08-26 |
| TriClip G5 Delivery System (P230007/S015) | ABBOTT MEDICAL | 2025-08-20 |
| MitraClip G5 Delivery System (P100009/S078) | ABBOTT MEDICAL | 2025-08-20 |
| MitraClip Delivery System (P100009/S079) | ABBOTT MEDICAL | 2025-08-18 |
| TriClip Delivery System (P230007/S016) | ABBOTT MEDICAL | 2025-08-18 |
| AVEIR AR 2 LSP203A Leadless Pacemaker (LP) (atrial) (P150035/S029) | ABBOTT MEDICAL | 2025-08-15 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S013) | ABBOTT MEDICAL | 2025-08-08 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S021) | ABBOTT MEDICAL | 2025-08-07 |
| 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 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S020) | ABBOTT MEDICAL | 2025-08-01 |
| Epic Plus Stented Tissue Valve; Epic Max Stented Tissue Valve (P040021/S059) | ABBOTT MEDICAL | 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 |
| Liberta RC DBS IPG (Model 62400) (P140009/S118) | ABBOTT MEDICAL | 2025-07-28 |
| CardioMEMS HF System (P100045/S083) | ABBOTT MEDICAL | 2025-07-28 |
| Eterna SCS IPG (Model 32400) (P010032/S236) | ABBOTT MEDICAL | 2025-07-28 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S012) | ABBOTT MEDICAL | 2025-07-25 |
| Proclaim DRG IPG (P150004/S087) | ABBOTT MEDICAL | 2025-07-23 |
| MitraClip G5 Delivery System (P100009/S077) | ABBOTT MEDICAL | 2025-07-23 |
| HeartMate II Left Ventricular Assist System (P060040/S120) | ABBOTT MEDICAL | 2025-07-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S109) | ABBOTT MEDICAL | 2025-07-17 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S108) | ABBOTT MEDICAL | 2025-07-11 |
| Proclaim SCS IPG (P010032/S239) | ABBOTT MEDICAL | 2025-07-02 |
| Aveir VR and DR Delivery Catheters (P150035/S024) | ABBOTT MEDICAL | 2025-07-02 |
| Proclaim DRG IPG (P150004/S086) | ABBOTT MEDICAL | 2025-07-02 |
| Infinity DBS IPG (P140009/S120) | ABBOTT MEDICAL | 2025-07-02 |
| HeartMate 3 Left Ventricular Assist System (P160054/S107) | ABBOTT MEDICAL | 2025-07-01 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S011) | ABBOTT MEDICAL | 2025-06-27 |
| TriClip G4 Delivery System; MitraClip G5 Delivery System, TriClip G5 Delivery System (P230007/S013) | ABBOTT MEDICAL | 2025-06-25 |
| MitraClip G4 Clip Delivery System; MitraClip NTR Clip Delivery System; MitraClip XTR Clip Delivery System (P100009/S075) | ABBOTT MEDICAL | 2025-06-25 |
| Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S119) | ABBOTT MEDICAL | 2025-06-24 |
| Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S238) | ABBOTT MEDICAL | 2025-06-24 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S019) | ABBOTT MEDICAL | 2025-06-20 |