| TriClip G5 Delivery System (P230007/S005) | ABBOTT MEDICAL | 2024-12-31 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S497) | Medtronic, Inc. | 2024-12-31 |
| MitraClip G5 System (P100009/S067) | ABBOTT MEDICAL | 2024-12-31 |
| Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Sp (P840001/S585) | Medtronic Neuromodulation | 2024-12-31 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S067) | Ferrosan Meidcal Devices A/S | 2024-12-30 |
| Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) (P110007/S015) | Johnson & Johnson Surgical Vision, Inc. | 2024-12-23 |
| Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le (P040029/S024) | Euclid Vision Corporation | 2024-12-23 |
| Activa and Percept Deep Brain Stimulation Therapy System (P960009/S486) | Medtronic, Inc. | 2024-12-23 |
| Alinity m HBV (P200013/S023) | Abbott Molecular, Inc. | 2024-12-23 |
| Sphere-9 Mapping and Ablation Catheter (P240013/S005) | Medtronic, Inc. | 2024-12-23 |
| Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet® PRO Dual Pack (P810031/S076) | Johnson & Johnson Surgical Vision, Inc. | 2024-12-23 |
| Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S586) | Medtronic Neuromodulation | 2024-12-23 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S498) | Medtronic, Inc. | 2024-12-23 |
| Vercise Genus Deep Brain Stimulation System (P150031/S080) | Boston Scientific Corp | 2024-12-23 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S004) | W. L. Gore & Associates, Inc. | 2024-12-23 |
| Sphere-9 Mapping and Ablation Catheter, Tubing Set (P240013/S004) | Medtronic, Inc. | 2024-12-23 |
| Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S222) | ABBOTT MEDICAL | 2024-12-20 |
| Liberta RC Deep Brain Stimulation (DBS) and NeuroSphere Digital Health App (P140009/S110) | ABBOTT MEDICAL | 2024-12-20 |
| LimFlow System (P220025/S004) | LimFlow, Inc. | 2024-12-20 |
| Avant HF, Neutrino NxT HF, Gallant HF, Neutrino NxT HF, Entrant HF (P030054/S408) | ABBOTT MEDICAL | 2024-12-20 |
| NeuroSphere Digital Health Apps (P150004/S080) | ABBOTT MEDICAL | 2024-12-20 |
| Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S229) | ABBOTT MEDICAL | 2024-12-20 |
| Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR (P910023/S455) | ABBOTT MEDICAL | 2024-12-20 |
| Zilver PTX Peripheral Drug-Eluting Stent (P100022/S043) | Cook Ireland, Ltd. | 2024-12-20 |
| Eterna Spinal Cord Simulation Implantable Pulse Generator (IPG) and NeuroSphere Digital Health App (P010032/S228) | ABBOTT MEDICAL | 2024-12-20 |
| Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S103) | ABBOTT MEDICAL | 2024-12-20 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S005) | Surmodics,Inc. | 2024-12-20 |
| Endurant Stent Graft System (P100021/S127) | Medtronic Vascular | 2024-12-20 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S070) | Medtronic Vascular | 2024-12-20 |
| PerClot Polysaccharide Hemostatic System (P210036/S002) | Baxter Healthcare Corporation | 2024-12-20 |
| Hydrus Microstent (P170034/S014) | Alcon Research, LLC | 2024-12-20 |
| Paradise Ultrasound Renal Denervation System, Paradise Cartridge, Paradise Generator (P220023/S004) | Recor Medical, Inc. | 2024-12-20 |
| VENTANA MMR RxDx Panel (P200019/S010) | Ventana Medical Systems | 2024-12-20 |
| VENTANA MMR RxDx Panel (P210001/S012) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2024-12-20 |
| alfapump System (P230044) | Sequana Medical NV | 2024-12-20 |
| Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S111) | ABBOTT MEDICAL | 2024-12-20 |
| FoundationOneCDx (F1CDx) (P170019/S056) | Foundation Medicine, Inc. | 2024-12-19 |
| InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator (P080025/S311) | Medtronic Neuromodulation | 2024-12-19 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S228) | Medtronic Cardiac Rhythm Disease Management | 2024-12-19 |
| Assurity, Assurity +, Endurity, Endurity Core, Endurity, Endurity Core, Zenus, Zenex (P880086/S341) | ABBOTT MEDICAL | 2024-12-19 |
| Avant, Neutrino NxT, Gallant, Entrant (P030054/S430) | ABBOTT MEDICAL | 2024-12-19 |
| LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory (P190017/S021) | DiaSorin, Inc. | 2024-12-19 |
| Sprint Quattro Lead (P920015/S295) | Medtronic, Inc. | 2024-12-19 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |
| SURGICEL Absorbable Hemostats (N12159/S118) | ETHICON, Inc. | 2024-12-19 |
| InterStim Therapy System, Sacral Nerve Stimulation (SNS) Implantable Neurostimulator (P970004/S416) | Medtronic Neuromodulation | 2024-12-19 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S062) | ETHICON, Inc. | 2024-12-19 |
| OPTIMIZER Smart System (P180036/S036) | Impulse Dynamics (Usa), Inc. | 2024-12-19 |
| Seprafilm Adhesion Barrier (P950034/S059) | Baxter Healthcare Corporation | 2024-12-19 |
| Altius® Direct Electrical Nerve Stimulation System (P230020/S001) | Neuros Medical, Inc. | 2024-12-19 |
| Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S095) | ABBOTT MEDICAL | 2024-12-19 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Serena Quadripolar C (P010015/S554) | Medtronic, Inc. | 2024-12-19 |
| Paradise Ultrasound Renal Denervation System, Paradise Generator (P220023/S005) | Recor Medical, Inc. | 2024-12-19 |
| TherOx Downstream System (P170027/S017) | Zoll Circulation, Inc. | 2024-12-19 |
| TECNIS 3-Piece Acrylic Monofocal (P990080/S061) | Johnson & Johnson Surgical Vision, Inc. | 2024-12-19 |
| SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS Opt (P980040/S169) | Johnson & Johnson Surgical Vision, Inc. | 2024-12-19 |
| ColoSense (P230001/S007) | Geneoscopy, Inc. | 2024-12-19 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S045) | Berlin Heart, Inc. | 2024-12-19 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S195) | Medtronic, Inc. | 2024-12-19 |
| Avant, Neutrino NxT, Gallant, Entrant (P910023/S474) | ABBOTT MEDICAL | 2024-12-19 |
| TECNIS 3-Piece Multifocal (P080010/S026) | Johnson & Johnson Surgical Vision, Inc. | 2024-12-19 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S803) | Medtronic, Inc. | 2024-12-19 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP (P030035/S207) | ABBOTT MEDICAL | 2024-12-19 |
| Apollo Onyx Delivery Micro Catheter (P030004/S037) | Ev3 Neurovascular | 2024-12-19 |
| Micra Transcatheter Pacing System (P150033/S197) | Medtronic, Inc. | 2024-12-19 |
| Microny family of Pacemakers (P970013/S095) | ABBOTT MEDICAL | 2024-12-18 |
| 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/S795) | Medtronic, Inc. | 2024-12-18 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S204) | ABBOTT MEDICAL | 2024-12-18 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S298) | Boston Scientific Corp | 2024-12-18 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S495) | Medtronic, Inc. | 2024-12-18 |
| 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/S802) | Medtronic, Inc. | 2024-12-18 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S425) | ABBOTT MEDICAL | 2024-12-18 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S111) | ABBOTT MEDICAL | 2024-12-18 |
| BIOFINITY (COMFILCON A) (P080011/S175) | CooperVision, Inc. | 2024-12-18 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S164) | Boston Scientific | 2024-12-18 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S028) | Foundation Medicine, Inc. | 2024-12-18 |
| Artegraft Collagen Vascular Graft (N16837/S035) | LeMaitre Vascular, Inc. | 2024-12-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, (P980016/S911) | Medtronic Cardiac Rhythm Disease Management | 2024-12-18 |
| H55 HYDROPHILIC CONTACT LENS (P890023/S052) | The Cooper Companies | 2024-12-18 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S244) | Guidant Corp. | 2024-12-18 |
| Avitene Flowable Collagen Hemostat (N17600/S040) | Davol Inc., Sub. C. R. Bard, Inc. | 2024-12-18 |
| Tunneling Tool (P920015/S296) | Medtronic, Inc. | 2024-12-18 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S196) | Medtronic, Inc. | 2024-12-18 |
| ESPRIT BTK Everolimus Eluting Bioresorbable Scaffold System (P230036/S008) | ABBOTT MEDICAL | 2024-12-18 |
| HiResolution Bionic Ear System (P960058/S166) | Advanced Bionics | 2024-12-18 |
| Aurora EV ICD (P220012/S037) | Medtronic, Inc. | 2024-12-18 |
| ENROUTE® Transcarotid Stent System (P140026/S031) | Boston Scientific Corporation | 2024-12-18 |
| NeuroPace Remote Monitor (P100026/S097) | NeuroPace, Inc. | 2024-12-18 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S379) | Boston Scientific Corp | 2024-12-18 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S436) | Medtronic, Inc. | 2024-12-18 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S053) | Cordis US Corporation | 2024-12-18 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S469) | ABBOTT MEDICAL | 2024-12-18 |
| Simplify Cervical Artificial Disc (P200022/S014) | Nuvasive, Inc. | 2024-12-18 |
| 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/S877) | Medtronic Cardiac Rhythm Disease Management | 2024-12-18 |
| BIOFINITY Toric (COMFILCON A) soft (hydrophilic) contact lenses for extended wear (P080011/S176) | CooperVision, Inc. | 2024-12-18 |
| VENTANA MMR RxDx Panel (P210001/S013) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2024-12-18 |
| Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Synergy® Spinal Cord Stimulation System, (P840001/S583) | Medtronic Neuromodulation | 2024-12-18 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S553) | Medtronic, Inc. | 2024-12-18 |
| PRECISE Nitinol Stent System (P030047/S050) | Cordis US Corporation | 2024-12-18 |
| Aveir Leadless System (P150035/S016) | ABBOTT MEDICAL | 2024-12-18 |