| Oxford Cementless Partial Knee System (P010014/S105) | Biomet Manufacturing Corp | 2024-11-22 |
| Avant, Entrant, Gallant, Neutrino NxT, Quadra Assura, Unify, Unify Assura, Unify Quadra (P030054/S428) | ABBOTT MEDICAL | 2024-11-22 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S086) | Medtronic, Inc. | 2024-11-22 |
| GEM 21S (P040013/S032) | Lynch Biologics, LLC | 2024-11-22 |
| 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/S800) | Medtronic, Inc. | 2024-11-21 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S552) | Medtronic, Inc. | 2024-11-21 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) (P040044/S107) | Cordis US Corporation | 2024-11-21 |
| Philips Laser System (P910001/S123) | Spectranetics Corp. | 2024-11-21 |
| Roadsaver/CASPER Carotid Stent Device (P210030) | MicroVention, Inc. | 2024-11-20 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S054) | Ventana Medical Systems, Inc. | 2024-11-20 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S126) | Medtronic Vascular | 2024-11-20 |
| 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/S906) | Medtronic Cardiac Rhythm Disease Management | 2024-11-20 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S551) | Medtronic, Inc. | 2024-11-20 |
| Thermocool SmartTouch Bi-Directional Navigation Catheter, Thermocool SmartTouch Uni-Directional Navigation Catheter (P040036/S099) | Biosense Webster, Inc. | 2024-11-20 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S047) | Berlin Heart, Inc. | 2024-11-20 |
| Theermocool SF NAV Bi-Directional Catheter (P990071/S062) | Biosense Webster, Inc. | 2024-11-20 |
| 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/S799) | Medtronic, Inc. | 2024-11-20 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S194) | Medtronic, Inc. | 2024-11-20 |
| EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter (P010068/S073) | Biosense Webster, Inc. | 2024-11-20 |
| QDOT Micro Uni-Directional Navigation Catheter, QDOT Micro Bi-Directional Navigation Catheter (P210027/S013) | Biosense Webster, Inc. | 2024-11-20 |
| NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T (P030031/S137) | Biosense Webster, Inc. | 2024-11-20 |
| 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/S872) | Medtronic Cardiac Rhythm Disease Management | 2024-11-20 |
| NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol (P990025/S073) | Biosense Webster, Inc. | 2024-11-20 |
| Aurora EV ICD (P220012/S034) | Medtronic, Inc. | 2024-11-20 |
| Cardiva VASCADE MVP XL Venous Vascular Closure System (VVCS) (P120016/S037) | Cardiva Medical, Inc. | 2024-11-19 |
| HeartMate 3 Left Ventricular Assist System (P160054/S091) | ABBOTT MEDICAL | 2024-11-19 |
| Bulkamid Urethral Bulking System (P170023/S019) | Boston Scientific Corporation | 2024-11-19 |
| HeartMate 3 Left Ventricular Assist System (P160054/S089) | ABBOTT MEDICAL | 2024-11-19 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S042) | Boston Scientific Corp | 2024-11-19 |
| TREO® Abdominal Stent-Graft System (P190015/S022) | Bolton Medical, Inc. | 2024-11-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S090) | ABBOTT MEDICAL | 2024-11-18 |
| Restore, Itrel®, Synergy®, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectr (P840001/S578) | Medtronic Neuromodulation | 2024-11-18 |
| Conformable Gore® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S137) | W. L. Gore & Associates, Inc. | 2024-11-18 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S005) | W. L. Gore & Associates, Inc. | 2024-11-18 |
| RelayPro Thoracic Stent-Graft System (P200045/S014) | Bolton Medical, Inc. | 2024-11-18 |
| Oxford Partial Knee System (P010014/S108) | Biomet Manufacturing Corp | 2024-11-18 |
| Neuroform Atlas Stent System (P180031/S009) | Stryker Neurovascular | 2024-11-18 |
| Valiant Thoratic Stent Graft with Captivia Delivery System (P100040/S064) | Medtronic Vascular | 2024-11-18 |
| 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator (P890057/S027) | ZOLL Medical Corporation | 2024-11-15 |
| nMARQ Catheter Interference Cable (P950005/S087) | Biosense Webster, Inc. | 2024-11-15 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F), Mynx Control Venous Vasc (P040044/S105) | Cordis US Corporation | 2024-11-15 |
| nMARQ Catheter Interference Cable (P030031/S135) | Biosense Webster, Inc. | 2024-11-15 |
| Smartablate System Interface Cable (P990071/S060) | Biosense Webster, Inc. | 2024-11-15 |
| nMARQ Catheter Interference Cable (P990025/S072) | Biosense Webster, Inc. | 2024-11-15 |
| nMARQ Catheter Interference Cable (P010068/S072) | Biosense Webster, Inc. | 2024-11-15 |
| Ethos AquaTech Evolve Monthly (P080011/S167) | CooperVision, Inc. | 2024-11-15 |
| nMARQ Catheter Interference Cable (P040036/S097) | Biosense Webster, Inc. | 2024-11-15 |
| Artisan Myopia (P030028/S010) | Ophtec BV | 2024-11-15 |
| MYNXGRIP Vascular Closure Device (5F, 6F/7F), MYNX CONTROL Vascular Closure Device (5F, 6F/7F), MYNX CONTROL VENOUS Vasc (P040044/S106) | Cordis US Corporation | 2024-11-15 |
| TX eco Extension Cable (P210027/S008) | Biosense Webster, Inc. | 2024-11-15 |
| Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (P240009/S002) | Contego Medical, Inc. | 2024-11-15 |
| Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant (P970051/S231) | Cochlear Americas | 2024-11-15 |
| CardioMEMS HF System (P100045/S078) | ABBOTT MEDICAL | 2024-11-15 |
| Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection (P240009/S001) | Contego Medical, Inc. | 2024-11-15 |
| Carelink SmartSync Platform Carelink SmartSync TM Common Application (P890003/S469) | Medtronic, Inc. | 2024-11-15 |
| R Series (P160022/S039) | ZOLL Medical Corporation | 2024-11-15 |
| CareLink SmartSync NuPace Application Software (P890003/S471) | Medtronic, Inc. | 2024-11-14 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S018) | W. L. Gore & Associates, Inc. | 2024-11-14 |
| FoundationOne Liquid CDx (P190032/S015) | Foundation Medicine, Inc. | 2024-11-14 |
| CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura (P980016/S901) | Medtronic Cardiac Rhythm Disease Management | 2024-11-14 |
| CareLink SmartSync Claria Amplia Compia App, CareLink SmartSync Cobalt, Crome App, CareLink SmartSync Viva Brava Evera A (P010031/S867) | Medtronic Cardiac Rhythm Disease Management | 2024-11-14 |
| SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S180) | Edwards Lifesciences, LLC | 2024-11-14 |
| CareLink SmartSync Percepta Serena Solara App (P010015/S545) | Medtronic, Inc. | 2024-11-14 |
| CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App (P150033/S191) | Medtronic, Inc. | 2024-11-14 |
| VNS Therapy System (P970003/S245) | LivaNova USA, Inc. | 2024-11-14 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S006) | Endotronix, Inc. | 2024-11-14 |
| Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl (P150005/S086) | Boston Scientific Corp | 2024-11-14 |
| CareLink SmartSync Azure Astra App (P980035/S790) | Medtronic, Inc. | 2024-11-14 |
| MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System (P140002/S028) | Terumo Medical Corporation | 2024-11-14 |
| BioMimics 3D® Vascular Stent System (P180003/S011) | Veryan Medical, Ltd. | 2024-11-14 |
| HeartMate 3 Left Ventricular Assist System (P160054/S088) | ABBOTT MEDICAL | 2024-11-14 |
| INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve (P150048/S084) | Edwards Lifesciences, LLC | 2024-11-14 |
| Coaxial Umbilical Cable (P020045/S111) | Medtronic Cryocath, LP | 2024-11-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S193) | Medtronic, Inc. | 2024-11-13 |
| End Cap, Epicardial Patch Lead, Sizing Sleeve (P900061/S174) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Manual Retraction Kit (P100010/S149) | Medtronic Cryocath, LP | 2024-11-13 |
| Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant (P970051/S232) | Cochlear Americas | 2024-11-13 |
| SCULPTRA (injectable poly-L Lactic acid) (P030050/S053) | Q-Med AB | 2024-11-13 |
| ActaStim-S Spine Fusion Stimulator (P190030/S003) | Theragen, Inc. | 2024-11-13 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S265) | Medtronic, Inc. | 2024-11-13 |
| 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/S871) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le (P920015/S294) | Medtronic, Inc. | 2024-11-13 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S473) | Medtronic, Inc. | 2024-11-13 |
| CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead (P850089/S170) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Myocardial Pacing Lead (P120017/S037) | Medtronic, Inc. | 2024-11-13 |
| CapSure Sense Lead, CapSure SP Lead, Vitatron Crystalline Lead (P830061/S226) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S150) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| Aurora EV ICD, Epsila EV Extravascular Lead (P220012/S033) | Medtronic, Inc. | 2024-11-13 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S187) | Medtronic, Inc. | 2024-11-13 |
| Transvene CS/SVC Lead (P980050/S144) | Medtronic, Inc. | 2024-11-13 |
| Eterna SCS Charging System (P010032/S225) | ABBOTT MEDICAL | 2024-11-13 |
| CapSureFix MRI Lead (P090013/S334) | Medtronic, Inc. | 2024-11-13 |
| Attain StarFix Lead (P060039/S117) | Medtronic, Inc. | 2024-11-13 |
| Azure/Astra Implantable Pulse Generator (IPG) (P980035/S788) | Medtronic, Inc. | 2024-11-13 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Solara (P010015/S549) | Medtronic, Inc. | 2024-11-13 |
| ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Knee System, ATTUNETM Revi (P830055/S330) | Depuy, Inc. | 2024-11-13 |
| Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S065) | Boston Scientific Corp | 2024-11-13 |
| Liberta RC DBS Charging System (P140009/S106) | ABBOTT MEDICAL | 2024-11-13 |
| 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/S905) | Medtronic Cardiac Rhythm Disease Management | 2024-11-13 |
| CapSure Epicardial Pacing Lead (P950024/S113) | Medtronic, Inc. | 2024-11-13 |