| Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S114) | Inspire Medical Systems | 2024-11-13 |
| 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/S797) | Medtronic, Inc. | 2024-11-13 |
| TriClip G4 System (P230007/S007) | ABBOTT MEDICAL | 2024-11-13 |
| CPR Uni-padz III (P160015/S016) | ZOLL Medical Corporation | 2024-11-12 |
| CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro- (P160022/S038) | ZOLL Medical Corporation | 2024-11-12 |
| Xstim Spine Fusion Stimulator (P230025/S001) | Xstim, Inc. | 2024-11-12 |
| COLOGUARD (P130017/S060) | Exact Sciences Corporation | 2024-11-12 |
| CERAMAX Ceramic Hip System (P070026/S115) | DePuy Orthopaedics, Inc. | 2024-11-08 |
| MemoryGel, MemoryGel Xtra Silicone Gel-Filled Breast Implants (P030053/S058) | Mentor Corp. | 2024-11-08 |
| LCS Total Knee System (P830055/S336) | Depuy, Inc. | 2024-11-08 |
| Angio-Seal Vascular Closure Device (P930038/S103) | Terumo Medical Corporation | 2024-11-08 |
| Minima Stent System (P240003/S001) | Renata Medical, Inc. | 2024-11-08 |
| INGEVITY+ (P150012/S162) | Boston Scientific | 2024-11-08 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S083) | Edwards Lifesciences, LLC | 2024-11-07 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S021) | Edwards Lifesciences, LLC | 2024-11-07 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S032) | Boston Scientific Corporation | 2024-11-07 |
| Saluda Medical Evoke® SCS System (P190002/S033) | Saluda Medical Pty, Ltd. | 2024-11-07 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S378) | Boston Scientific Corp | 2024-11-07 |
| LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC, (P910073/S180) | Boston Scientific | 2024-11-07 |
| AvertD and AvertD Buccal Sample Collection Kit (P230032/S002) | AutoGenomics, Inc. | 2024-11-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S179) | Edwards Lifesciences, LLC | 2024-11-07 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S059) | Edwards Lifesciences, LLC | 2024-11-07 |
| Apollo Onyx Delivery Micro Catheter (P030004/S036) | Ev3 Neurovascular | 2024-11-07 |
| EMBLEM S-ICD ELECTRODE 45 CM 3501 (P110042/S200) | Boston Scientific Corporation | 2024-11-07 |
| Superion Indirect Decompression System (IDS) System (P140004/S034) | Boston Scientific Neuromodulation | 2024-11-07 |
| NAV 2 Quadpole LV Straight 86CM 4671, NAV 2 Quadpole LV Straight 95CM 4672, NAV 2 Quadpole LV Short Spiral 86CM 4674, N (P010012/S587) | Boston Scientific Corp | 2024-11-07 |
| TruSight Oncology Comprehensive (P230011/S001) | Illumina, Inc. | 2024-11-07 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S078) | Boston Scientific Corp | 2024-11-07 |
| INFUSE Bone Graft (P050053/S064) | Medtronic, Inc. | 2024-11-06 |
| GUARDIO/VESTA charger (P180036/S032) | Impulse Dynamics (Usa), Inc. | 2024-11-06 |
| HEMOBLAST Bellows (P170012/S029) | Dilon Technologies, Inc. | 2024-11-06 |
| TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) (P990027/S022) | Technolas Perfect Vision GmbH | 2024-11-06 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S093) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| INFUSE Bone Graft (P000054/S073) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006) | Biosense Webster, Inc. | 2024-11-06 |
| Mentor MemoryGel® Silicone Gel-Filled Breast Implant PMA (P030053/S074) | Mentor Corp. | 2024-11-05 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG (P980035/S798) | Medtronic, Inc. | 2024-11-05 |
| Mentor MemoryShape® Silicone Gel-Filled Breast Implant PMA (P060028/S052) | Mentor Worldwide, LLC | 2024-11-05 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® S (P840001/S576) | Medtronic Neuromodulation | 2024-11-05 |
| Axonics Sacral Neuromodulation System (P180046/S091) | Boston Scientific Corporation | 2024-11-05 |
| Axonics Sacral Neuromodulation System (P190006/S091) | Boston Scientific Corporation | 2024-11-05 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S488) | Medtronic, Inc. | 2024-11-05 |
| CentriMag Circulatory Support System (P170038/S022) | Abbott | 2024-11-05 |
| Consulta CRT-P, Syncra CRT-P (P010015/S550) | Medtronic, Inc. | 2024-11-05 |
| MI Cancer Seek (P240010) | Caris Life Sciences | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| Morcher Capsular Tension Ring (P010059/S008) | Morcher GmbH | 2024-11-04 |
| Arista AH (P050038/S042) | Davol, Inc. | 2024-11-04 |
| FoundationOne CDx (F1CDx) (P170019/S061) | Foundation Medicine, Inc. | 2024-11-02 |
| FoundationOne Liquid CDx (F1LCDx) (P190032/S026) | Foundation Medicine, Inc. | 2024-11-02 |
| ACCOLADE (N970003/S295) | Boston Scientific Corp | 2024-11-01 |
| Amplatzer Muscular VSD Occluder (P040040/S048) | ABBOTT MEDICAL | 2024-11-01 |
| ACCOLADE (P030005/S241) | Guidant Corp. | 2024-11-01 |
| Senza Spinal Cord Stimulation (SCS) Systems (P130022/S050) | Nevro Corporation | 2024-11-01 |
| CentriMag Circulatory Support System (P170038/S021) | Abbott | 2024-11-01 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S072) | Boston Scientific Corp | 2024-11-01 |
| ACCOLADE (P150012/S160) | Boston Scientific | 2024-11-01 |
| Light Adjustable Lens, Light Delivery Device (P160055/S040) | Rxsight, Inc. | 2024-10-31 |
| Saluda Medical Evoke SCS System (P190002/S028) | Saluda Medical Pty, Ltd. | 2024-10-31 |
| DuraSeal Dural Sealant System (P040034/S039) | Integra LifeSciences Corporation | 2024-10-30 |
| MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM (P890055/S088) | Intera Oncology | 2024-10-30 |
| DuraSeal Exact Spine Sealant System (P080013/S028) | Integra LifeSciences Corporation | 2024-10-30 |
| Aurora EV ICD (P220012/S031) | Medtronic, Inc. | 2024-10-30 |
| 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/S902) | Medtronic Cardiac Rhythm Disease Management | 2024-10-30 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S138) | Vistakon, Division of Johnson & Johnson Vision Car | 2024-10-30 |
| Optune Gio (P100034/S033) | Novocure, GmbH | 2024-10-30 |
| 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/S868) | Medtronic Cardiac Rhythm Disease Management | 2024-10-30 |
| nGEN Pump (P990071/S061) | Biosense Webster, Inc. | 2024-10-30 |
| Impella CP with SmartAssist (P140003/S121) | Abiomed, Inc. | 2024-10-29 |
| Juvederm Volux XC (P110033/S089) | Allergan | 2024-10-29 |
| BIOFINITY (COMFILCON A) (P080011/S174) | CooperVision, Inc. | 2024-10-29 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S020) | Edwards Lifesciences, LLC | 2024-10-29 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S043) | Cardiovascular Systems, Inc. | 2024-10-28 |
| Assurity, Assurity +, Endurity, Endurity Core, Zenus, Zenex, Accent (P880086/S340) | ABBOTT MEDICAL | 2024-10-28 |
| SCS Implantable Neurostimulators (P840001/S574) | Medtronic Neuromodulation | 2024-10-28 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S062) | Boston Scientific Corp | 2024-10-28 |
| Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S094) | ABBOTT MEDICAL | 2024-10-28 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, Avant, Neutrino NxT, Gallant, Entrant (P030054/S427) | ABBOTT MEDICAL | 2024-10-28 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP, Anthem (P030035/S206) | ABBOTT MEDICAL | 2024-10-28 |
| Avant, Neutrino NxT, Gallant, Entrant, Fortify VR, Fortify DR, Ellipse VR, Ellipse DR, Fortify Assura VR, Fortify A (P910023/S472) | ABBOTT MEDICAL | 2024-10-28 |
| Defibrillator, Implantable, Dual-Chamber (P000009/S115) | Biotronik, Inc. | 2024-10-25 |
| FoundationOne CDx (P170019/S058) | Foundation Medicine, Inc. | 2024-10-25 |
| Implantable Cardioverter Defibrillator (Non- Crt) (P980023/S131) | Biotronik, Inc. | 2024-10-25 |
| 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/S160) | Biotronik, Inc. | 2024-10-25 |
| Paradise® Ultrasound Renal Denervation System (P220023/S003) | Recor Medical, Inc. | 2024-10-25 |
| Pulse Generator, Permanent, Implantable (P950037/S264) | Biotronik, Inc. | 2024-10-25 |
| 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/S793) | Medtronic, Inc. | 2024-10-25 |
| Cochlear Slimline Coil, Cochlear Slimline Coil (5(I)), Nucleus® 7 Aqua+ Coil (5(I)), Nucleus 7 Aqua+ Coil (P970051/S230) | Cochlear Americas | 2024-10-25 |
| PRECISE PRO Rx Nitinol Stent System (P030047/S048) | Cordis US Corporation | 2024-10-25 |
| Implantable Cardioverter Defibrillator (Non- Crt), Defibrillator, Implantable, Dual-Chamber, Defibrillator, Automatic Im (P050023/S188) | Biotronik, Inc. | 2024-10-25 |
| ENROUTE® Transcarotid Stent System (P140026/S030) | Boston Scientific Corporation | 2024-10-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S546) | Medtronic, Inc. | 2024-10-25 |
| The S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System (P120002/S027) | Cordis US Corporation | 2024-10-25 |
| Nucleus 24 Cochlear Implant System (P970051/S229) | Cochlear Americas | 2024-10-25 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S161) | Biotronik, Inc. | 2024-10-25 |
| S.M.A.R.T. CONTROL Vascular Stent System, S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S052) | Cordis US Corporation | 2024-10-25 |
| FARAWAVE Pulsed Field Ablation Catheter (P230030/S006) | Farapulse, Inc. | 2024-10-24 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S108) | ABBOTT MEDICAL | 2024-10-24 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S134) | Abbott Vascular | 2024-10-24 |
| Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S172) | CooperVision, Inc. | 2024-10-24 |