| Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D (P010031/S908) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Altius® Direct Electrical Nerve Stimulation System (P230020/S005) | Neuros Medical, Inc. | 2025-12-03 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S910) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (P150033/S219) | Medtronic, Inc. | 2025-12-03 |
| Aurora EV ICD DVEA3E4 (P220012/S060) | Medtronic, Inc. | 2025-12-03 |
| CareLink SmartSync Device Manager Base 24970A (P890003/S483) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (P980016/S943) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S575) | Medtronic, Inc. | 2025-12-03 |
| Aurora EV ICD (DVEA3E4) (P220012/S062) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (P010031/S907) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen (P980035/S827) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD (P980016/S940) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 (P980035/S826) | Medtronic, Inc. | 2025-12-03 |
| Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ (P980016/S941) | Medtronic Cardiac Rhythm Disease Management | 2025-12-03 |
| Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) (P150033/S218) | Medtronic, Inc. | 2025-12-02 |
| CentriMag Circulatory Support System (P170038/S025) | Abbott | 2025-12-01 |
| WOLVERINE Coronary Cutting Balloon (P950020/S147) | Boston Scientific Corp | 2025-12-01 |
| IsoPSA Assay (P200048) | Cleveland Diagnostics, Inc. | 2025-11-28 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S525) | Medtronic, Inc. | 2025-11-26 |
| InterStim Therapy System, Verify Evaluation System (P080025/S334) | Medtronic Neuromodulation | 2025-11-26 |
| Altaviva (P240011/S003) | Medtronic Neuromodulation | 2025-11-26 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| MED-EL CI System (P000025/S134) | Med-El Corp. | 2025-11-26 |
| InterStim Therapy System, Verify Evaluation System (P970004/S439) | Medtronic Neuromodulation | 2025-11-26 |
| Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Ve (P840001/S613) | Medtronic Neuromodulation | 2025-11-26 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S454) | Medtronic, Inc. | 2025-11-26 |
| ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P980049/S146) | MicroPort CRM USA, Inc. | 2025-11-25 |
| Embrace(TM) Hydrogel Embolic System (P250003/S001) | Instylla, Inc. | 2025-11-25 |
| ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P130010/S002) | MicroPort CRM USA, Inc. | 2025-11-25 |
| Lumicell Direct Visualization System (DVS) (P230014/S004) | Lumicell, Inc. | 2025-11-25 |
| CorPASS System (P230040/S024) | Endotronix, Inc. | 2025-11-25 |
| XPS with Steen Solution Perfusate (P180014/S013) | Xvivo Perfusion, Inc. | 2025-11-25 |
| VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand (P970003/S251) | LivaNova USA, Inc. | 2025-11-25 |
| ENERGYA/TALENTIA ICDs & CRT-Ds, SmartTouch Programmer Software Modules, SmartView Connect App, & RMS (P060027/S106) | MicroPort CRM USA, Inc. | 2025-11-25 |
| Micra Transcatheter Pacing Systems (P150033/S217) | Medtronic, Inc. | 2025-11-25 |
| Cologuard® (P130017/S066) | Exact Sciences Corporation | 2025-11-24 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S027) | The Spectranetics Corp. | 2025-11-24 |
| Envision Mammography Platform (P080003/S011) | Hologic, Inc. | 2025-11-24 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048) | W. L. Gore & Associates, Inc. | 2025-11-24 |
| Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack (P200032/S003) | Occlutech Holding AG | 2025-11-24 |
| Medtronic DBS Therapy for Dystonia (P960009/S482) | Medtronic, Inc. | 2025-11-22 |
| QuantiFERON-TB Gold Plus Test (P010033/S051) | Qiagen | 2025-11-21 |
| LIFEPAK® 35 monitor/defibrillator (P160026/S064) | Physio-Control, Inc. | 2025-11-21 |
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Oncomine Dx Target Test (P160045/S051) | Life Technologies Corporation | 2025-11-21 |
| THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE (P860003/S112) | Therakos Development Limited | 2025-11-21 |
| OPRA Implant System, Abutment component (P190009/S006) | Integrum AB | 2025-11-20 |
| Durata Defibrillation Leads (P950022/S150) | ABBOTT MEDICAL | 2025-11-20 |
| Sphere-9 TM Mapping and Ablation Catheter (P240013/S018) | Medtronic, Inc. | 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 |
| Sientra Silicone Gel Breast Implants (P070004/S045) | Tiger Aesthetics Medical, LLC | 2025-11-20 |
| MediBeacon® Transdermal GFR Measurement System (GFR) (P230019/S003) | Medibeacon, Inc. | 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 |
| Oncomine Dx Target Test (P160045/S050) | Life Technologies Corporation | 2025-11-19 |
| OPTIMIZER SMART Mini IPG (P180036/S034) | Impulse Dynamics (Usa), Inc. | 2025-11-19 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (P230022/S004) | Element Science, Inc. | 2025-11-19 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S019) | Edwards Lifesciences, LLC | 2025-11-19 |
| Total Artificial Heart (P030011/S093) | Syncardia Systems, LLC | 2025-11-19 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (P230022/S002) | Element Science, Inc. | 2025-11-18 |
| Duo Venous Stent System (P230021/S002) | Philips Image Guided Therapy Corporation | 2025-11-18 |
| MENTOR Saline-Filled and SPECTRUM Breast Implants (P990075/S065) | Mentor Worldwide, LLC | 2025-11-18 |
| EPi-Sense ST Coagulation System (P200002/S013) | AtriCure, Inc. | 2025-11-14 |
| VISIAN ICL (IMPLANTABLE COLLAMER LENS) (P030016/S048) | STAAR Surgical Company | 2025-11-14 |
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S521) | Medtronic, Inc. | 2025-11-13 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S451) | Medtronic, Inc. | 2025-11-13 |
| Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (P840001/S610) | Medtronic Neuromodulation | 2025-11-13 |
| HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (P200007/S001) | Graphic Controls D.B.A. Vermed | 2025-11-12 |
| CardioMEMS HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) (P100045/S087) | ABBOTT MEDICAL | 2025-11-10 |
| Mosaic Bioprosthesis (P990064/S093) | Medtronic, Inc. | 2025-11-10 |
| Freestyle Bioprosthesis (P970031/S076) | Medtronic, Inc. | 2025-11-10 |
| Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (P170006/S038) | Medtronic, Inc. | 2025-11-10 |
| Hancock II Bioprosthesis (P980043/S084) | Medtronic, Inc. | 2025-11-10 |
| Saluda Medical Evoke® SCS System (P190002/S045) | Saluda Medical Pty, Ltd. | 2025-11-08 |
| Protégé GPS self-expanding Peripheral Stent System (P060001/S052) | Medtronic Vascular, Inc. | 2025-11-07 |
| Deep Brain Stimulation (DBS) Neurostimulation System (P140009/S124) | ABBOTT MEDICAL | 2025-11-07 |
| EverFlex self-expanding Peripheral Stent System (EverFlex) (P110023/S061) | Medtronic Vascular, Inc. | 2025-11-07 |
| Propel Contour Sinus Implant (P100044/S058) | Intersect Ent. | 2025-11-07 |
| Spinal Cord Stimulation (SCS) Neurostimulation System (P010032/S243) | ABBOTT MEDICAL | 2025-11-07 |
| SpineSeal Spine Sealant (P240027/S004) | Pramand, LLC | 2025-11-07 |
| Dorsal Root Ganglion (DRG) Neurostimulation System (P150004/S090) | ABBOTT MEDICAL | 2025-11-07 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D (P130013/S081) | Boston Scientific Corp | 2025-11-06 |
| Adherus AutoSpray Dural Sealant (P130014/S021) | Stryker Leibinger GmbH & Co KG | 2025-11-06 |
| Genio® System 2.1 (P240024/S002) | Nyxoah S.A. | 2025-11-06 |
| LIFEPAK® CR2 Automated External Defibrillator (P170018/S023) | Physio-Control, Inc. | 2025-11-06 |
| OncoMate® MSI Dx Analysis System (P240026) | Promega Corporation | 2025-11-05 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S508) | Medtronic, Inc. | 2025-11-04 |
| nterStim Therapy System, Verify Evaluation System (P080025/S321) | Medtronic Neuromodulation | 2025-11-04 |
| InterStim Therapy System, Verify Evaluation System (P970004/S426) | Medtronic Neuromodulation | 2025-11-04 |
| Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, (P840001/S596) | Medtronic Neuromodulation | 2025-11-04 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S112) | ABBOTT MEDICAL | 2025-11-04 |
| Restylane® Lyft with Lidocaine (P040024/S142) | Q-Med AB | 2025-11-04 |
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S013) | MicroVention, Inc. | 2025-11-02 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S013) | Edwards Lifesciences, LLC | 2025-10-31 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |