| Assurity, Assurity+, Endurity, Endurity Core, Zenus, Zenex Family of Pacemakers (P880086/S336) | ABBOTT MEDICAL | 2024-05-01 |
| LATITUDE Programming System (P910077/S193) | Boston Scientific | 2024-04-30 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S499) | Boston Scientific | 2024-04-30 |
| Eterna SCS IPG (P010032/S214) | ABBOTT MEDICAL | 2024-04-30 |
| INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S236) | Guidant Corp. | 2024-04-30 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P010012/S580) | Boston Scientific Corp | 2024-04-30 |
| Hydrus® Microstent (P170034/S012) | Alcon Research, LLC | 2024-04-30 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S291) | Boston Scientific Corp | 2024-04-30 |
| Liberta RC DBS IPG (P140009/S096) | ABBOTT MEDICAL | 2024-04-30 |
| EMBLEM S-ICD (P110042/S193) | Boston Scientific Corporation | 2024-04-30 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S155) | Boston Scientific | 2024-04-30 |
| WaveWriter Alpha SCS System (P030017/S371) | Boston Scientific Corp | 2024-04-29 |
| LIFEPAK® 35 Monitor/Defibrillator (P160026/S047) | Physio-Control, Inc. | 2024-04-29 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S011) | Cook Medical Incorporated | 2024-04-29 |
| GORE® CARDIOFORM ASD Occluder, GORE® CARDIOFORM Septal Occluder (P050006/S109) | W. L. Gore & Associates, Inc. | 2024-04-29 |
| Zenith Dissection Endovascular System (P180001/S012) | William Cook Europe Aps | 2024-04-29 |
| SCULPTRA (injectable poly-L Lactic acid) (P030050/S050) | Q-Med AB | 2024-04-29 |
| HeartWare HVAD System (P100047/S215) | Medtronic | 2024-04-29 |
| R3 Delta Ceramic Hip System (P150030/S036) | Smith & Nephew, Inc. | 2024-04-29 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| LIFEPAK® 35 Monitor/Defibrillator (P160026/S048) | Physio-Control, Inc. | 2024-04-29 |
| Activa Deep Brain Stimulation Therapy System, Percept PC and RC BrainSense (P960009/S477) | Medtronic, Inc. | 2024-04-26 |
| Bellafill Dermal Filler (P020012/S047) | Tiger Aesthetics Medical, LLC | 2024-04-26 |
| Vascular Closure System (VCS) (P120016/S036) | Cardiva Medical, Inc. | 2024-04-26 |
| Intellis, Sequentia LT, and Vanta Spinal Cord Stimulation Systems (P840001/S563) | Medtronic Neuromodulation | 2024-04-26 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036) | ABBOTT MEDICAL | 2024-04-26 |
| Cobalt XT MRI ICD (P980016/S890) | Medtronic Cardiac Rhythm Disease Management | 2024-04-26 |
| CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D (P010031/S856) | Medtronic Cardiac Rhythm Disease Management | 2024-04-26 |
| Heart Failure Risk Status (HFRS), Triage-HF (P890003/S466) | Medtronic, Inc. | 2024-04-26 |
| Pipeline Flex Embolization Device with Shield Technology (PED2), Pipeline Vantage Embolization Device with Shield Tec (P100018/S044) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-04-25 |
| FoundationOne CDx (P170019/S045) | Foundation Medicine, Inc. | 2024-04-25 |
| 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/S855) | Medtronic Cardiac Rhythm Disease Management | 2024-04-25 |
| TherOx Downstream System (P170027/S013) | Zoll Circulation, Inc. | 2024-04-25 |
| Aurora EV-ICD (P220012/S021) | Medtronic, Inc. | 2024-04-25 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera X (P980016/S889) | Medtronic Cardiac Rhythm Disease Management | 2024-04-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S536) | Medtronic, Inc. | 2024-04-25 |
| InterStim Therapy System, Verify Evaluation System (P080025/S293) | Medtronic Neuromodulation | 2024-04-24 |
| Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int (P840001/S512) | Medtronic Neuromodulation | 2024-04-24 |
| CentriMag Circulatory Support System (P170038/S015) | Abbott | 2024-04-24 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S003) | Edwards Lifesciences, LLC | 2024-04-24 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S020) | Biotronik AG | 2024-04-24 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S037) | Biotronik AG | 2024-04-24 |
| SCS Neurostimulators Implantable Itrel Family (P840001/S561) | Medtronic Neuromodulation | 2024-04-24 |
| DBS Neurostimulators Implantable Activa Family (P960009/S475) | Medtronic, Inc. | 2024-04-24 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S425) | Medtronic, Inc. | 2024-04-24 |
| Model 4063 Stimulation Lead and 4340 Sensing Lead (P130008/S109) | Inspire Medical Systems | 2024-04-24 |
| Aurora EV-ICD System (P220012/S020) | Medtronic, Inc. | 2024-04-24 |
| InterStim Therapy System, Verify Evaluation System (P970004/S398) | Medtronic Neuromodulation | 2024-04-24 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage (P130013/S068) | Boston Scientific Corp | 2024-04-24 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S476) | Medtronic, Inc. | 2024-04-24 |
| Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S562) | Medtronic Neuromodulation | 2024-04-24 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon (P190008/S028) | Medtronic Vascular, Inc. | 2024-04-23 |
| LIFEPAK® CR2 defibrillator (P170018/S019) | Physio-Control, Inc. | 2024-04-23 |
| Mosaic Bioprosthesis (P990064/S088) | Medtronic, Inc. | 2024-04-22 |
| CentriMag Circulatory Support System (P170038/S014) | Abbott | 2024-04-22 |
| Avalus Bioprosthesis and Avalus Ultra Bioprosthesis (P170006/S033) | Medtronic, Inc. | 2024-04-22 |
| Freestyle Bioprosthesis (P970031/S073) | Medtronic, Inc. | 2024-04-22 |
| LIAISON Murex Anti-HBc and LIAISON Murex Control Anti-HBc (P180038/S017) | DiaSorin, Inc. | 2024-04-22 |
| Hancock Valved Conduit (P870078/S051) | Medtronic, Inc. | 2024-04-22 |
| Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (P170006/S034) | Medtronic, Inc. | 2024-04-22 |
| Hancock II Bioprosthesis (P980043/S079) | Medtronic, Inc. | 2024-04-22 |
| Hancock Modified Orifice Valved Conduit (P790007/S066) | Medtronic Heart Valves | 2024-04-22 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S109) | Biotronik, Inc. | 2024-04-19 |
| LimFlow System (P220025/S003) | LimFlow, Inc. | 2024-04-19 |
| BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si (P180050/S011) | Cvrx, Inc. | 2024-04-19 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S125) | Biotronik, Inc. | 2024-04-19 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T, In (P050023/S182) | Biotronik, Inc. | 2024-04-19 |
| Medtronic MiniMed 780G insulin pump (MMT-1884), Medtronic MiniMed 780G insulin pump kit (MMT-1894) (P160017/S116) | Medtronic Minimed, Inc. | 2024-04-19 |
| Medtronic Evolut FX+ Transcatheter Aortic Valve, Evolut FX Delivery Catheter System, Evolut FX Loading System (P130021/S161) | Medtronic, Inc. | 2024-04-19 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S016) | Great Batch Medical | 2024-04-19 |
| oncoRevealTM CDx (P200011/S001) | Pillar Biosciences | 2024-04-18 |
| GORE® CARDIOFORM ASD Occluder (P050006/S110) | W. L. Gore & Associates, Inc. | 2024-04-18 |
| BD Onclarity HPV Assay (P160037/S019) | Becton, Dickinson and Company | 2024-04-18 |
| Berlin Heart EXCOR Pediatric Ventricular Assist Device (P160035/S039) | Berlin Heart, Inc. | 2024-04-18 |
| Sculptra, Sculptra Aesthetic (P030050/S041) | Q-Med AB | 2024-04-18 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S067) | Boston Scientific Corp | 2024-04-18 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S136) | Vistakon, Division of Johnson & Johnson Vision Car | 2024-04-17 |
| Lumicell Direct Visualization System (DVS) (P230014) | Lumicell, Inc. | 2024-04-17 |
| Precision7 , Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (P220007/S004) | Alcon Laboratories, Inc. | 2024-04-17 |
| RelayPro Stent-Graft System (P200045/S011) | Bolton Medical, Inc. | 2024-04-17 |
| Impella RP and Impella RP with SmartAssist (P170011/S053) | Abiomed, Inc. | 2024-04-17 |
| RelayPlus Thoracic Stent-Graft System (P110038/S031) | Bolton Medical, Inc. | 2024-04-17 |
| Simplify® Cervical Artificial Disc (P200022/S013) | Nuvasive, Inc. | 2024-04-17 |
| TREO Abdominal Stent-Graft System (P190015/S017) | Bolton Medical, Inc. | 2024-04-17 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S259) | Medtronic, Inc. | 2024-04-16 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S065) | Boston Scientific Corp | 2024-04-16 |
| Epsila EV Extravascular Lead (P220012/S022) | Medtronic, Inc. | 2024-04-16 |
| Micra AV TPS, Micra TPS (P150033/S187) | Medtronic, Inc. | 2024-04-16 |
| HeartMate 3 Left Ventricular Assist System (P160054/S077) | ABBOTT MEDICAL | 2024-04-16 |
| Model 2740 Inspire Physician Programmer (P130008/S108) | Inspire Medical Systems | 2024-04-16 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S183) | Medtronic, Inc. | 2024-04-16 |
| Y Adaptor/Extender Kit, Sprint Quattro Lead (P920015/S285) | Medtronic, Inc. | 2024-04-16 |
| Apollo Onyx Delivery Micro Catheter 1.5 cm, Apollo Onyx Delivery Micro Catheter 3.0 cm (P030004/S031) | Ev3 Neurovascular | 2024-04-16 |
| HeartMate II Left Ventricular Assist System (P060040/S103) | ABBOTT MEDICAL | 2024-04-16 |
| HV Splitter, Sprint Quattro Lead (P920015/S286) | Medtronic, Inc. | 2024-04-16 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S222) | Medtronic Cardiac Rhythm Disease Management | 2024-04-16 |
| FoundationOne®Liquid CDx (F1LCDx) (P190032/S020) | Foundation Medicine, Inc. | 2024-04-16 |
| Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack (P810031/S075) | Johnson & Johnson Surgical Vision, Inc. | 2024-04-15 |
| Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact (P040029/S022) | Euclid Vision Corporation | 2024-04-15 |
| Magtrace and Sentimag Magnetic Localization System (P160053/S009) | Endomagnetics Ltd., | 2024-04-15 |