| PASCAL Precision Transcatheter Valve Repair System (P220003/S015) | Edwards Lifesciences, LLC | 2024-04-15 |
| Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) (P110007/S014) | Johnson & Johnson Surgical Vision, Inc. | 2024-04-15 |
| Axonics Sacral Neuromodulation System (P180046/S081) | Boston Scientific Corporation | 2024-04-12 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) (P040044/S101) | Cordis US Corporation | 2024-04-12 |
| Axonics Sacral Neuromodulation System (P190006/S081) | Boston Scientific Corporation | 2024-04-12 |
| OPTIMIZER Smart System (P180036/S027) | Impulse Dynamics (Usa), Inc. | 2024-04-12 |
| LIFEPAK® 35 Monitor/Defibrillator (P160026/S040) | Physio-Control, Inc. | 2024-04-12 |
| Roche cobas 4800 BRAF V600 Mutation Test (P110020/S042) | Roche Molecular Systems, Inc. | 2024-04-11 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S001) | Boston Scientific Corporation | 2024-04-11 |
| Roche cobas DNA Sample Preparation Kit (P140023/S029) | Roche Molecular Systems, Inc. | 2024-04-11 |
| SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface (P200040/S001) | Delphinus Medical Technologies | 2024-04-11 |
| Cerene Cryotherapy Device (Model Number FGS-7000) (P180032/S016) | Channel Medsystems, Inc. | 2024-04-11 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System-RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent Sys (P160043/S079) | Medtronic Vascular | 2024-04-11 |
| Percept RC BrainSense (P960009/S472) | Medtronic, Inc. | 2024-04-11 |
| Senza® Spinal Cord Stimulation (SCS) System (P130022/S057) | Nevro Corporation | 2024-04-11 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S048) | Medinol, Ltd. | 2024-04-10 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S062) | Medtronic Vascular | 2024-04-10 |
| Medtronic CoreValve Evolut R System (P130021/S160) | Medtronic, Inc. | 2024-04-10 |
| Aurora EV-ICD System (P220012/S019) | Medtronic, Inc. | 2024-04-10 |
| Axonics Sacral Neuromodulation System (P190006/S082) | Boston Scientific Corporation | 2024-04-10 |
| Axonics Sacral Neuromodulation System (P180046/S082) | Boston Scientific Corporation | 2024-04-10 |
| Medtronic CoreValve Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs (P100021/S120) | Medtronic Vascular | 2024-04-10 |
| CareLink SmartSync (P890003/S465) | Medtronic, Inc. | 2024-04-10 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S080) | Medtronic Vascular | 2024-04-10 |
| Symplicity Spyral Renal Denervation System (P220026/S006) | Medtronic, Inc. | 2024-04-10 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S053) | Nevro Corporation | 2024-04-10 |
| Carbomedics Prosthetic Heart Valve (P900060/S066) | Corcym S.r.l. | 2024-04-09 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S424) | Medtronic, Inc. | 2024-04-09 |
| Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S559) | Medtronic Neuromodulation | 2024-04-09 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S470) | Medtronic, Inc. | 2024-04-09 |
| OPRA Implant System (P190009/S005) | Integrum AB | 2024-04-09 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S064) | ABBOTT MEDICAL | 2024-04-09 |
| 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/S779) | Medtronic, Inc. | 2024-04-08 |
| SelectSecure Lead (P030036/S146) | Medtronic Cardiac Rhythm Disease Management | 2024-04-08 |
| Light Adjustable Lens, Light Delivery Device (P160055/S035) | Rxsight, Inc. | 2024-04-08 |
| EUFLEXXA (P010029/S038) | Ferring Pharmaceuticals, Inc. | 2024-04-06 |
| Visi-Pro Balloon-Expandable Peripheral Stent System, lntraStent DoubleStrut Stent (P030045/S009) | Medtronic Vascular, Inc. | 2024-04-05 |
| BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLATIP MIFI XP Cable, (P020025/S139) | Boston Scientific | 2024-04-05 |
| Abre Venous Self-expanding Stent System (P200026/S008) | Medtronic Vascular, Inc. | 2024-04-05 |
| TheraSphere (P200029/S009) | Boston Scientific Corporation | 2024-04-05 |
| Protégé RX Carotid Stent System, tégé GPS Self-Expanding Peripheral Stent System (P060001/S040) | Medtronic Vascular, Inc. | 2024-04-05 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S212) | ABBOTT MEDICAL | 2024-04-05 |
| BLAZER OI Catheter Cable, INTELLATIP MIFI OI Cable, INTELLANAV Ablation Catheter Cable (P150005/S077) | Boston Scientific Corp | 2024-04-05 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S070) | ABBOTT MEDICAL | 2024-04-05 |
| GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S014) | W. L. Gore and Associates, Inc. | 2024-04-05 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S094) | ABBOTT MEDICAL | 2024-04-05 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S044) | Medtronic Vascular, Inc. | 2024-04-05 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S194) | Boston Scientific Corporation | 2024-04-05 |
| BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLANAV Ablation Cathet (P920047/S131) | Boston Scientific Corp | 2024-04-05 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S056) | Abbott Diabetes Care, Inc. | 2024-04-05 |
| Amplia MRI CRT-D,Amplia MRI Quad CRTD, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D,Cobalt MRI (P010031/S852) | Medtronic Cardiac Rhythm Disease Management | 2024-04-04 |
| Aurora EV ICD (P980016/S886) | Medtronic Cardiac Rhythm Disease Management | 2024-04-04 |
| 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 (P220012/S017) | Medtronic, Inc. | 2024-04-04 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S002) | Edwards Lifesciences, LLC | 2024-04-04 |
| CapSure Sense Lead (P830061/S221) | Medtronic Cardiac Rhythm Disease Management | 2024-04-04 |
| Aveir VR Delivery Catheter, Aveir DR Delivery Catheter (P150035/S009) | ABBOTT MEDICAL | 2024-04-04 |
| CapSureFix Novus Lead (P930039/S258) | Medtronic, Inc. | 2024-04-04 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| mySCS GO Therapy Controller App (P030017/S358) | Boston Scientific Corp | 2024-04-04 |
| Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology (P810002/S121) | ABBOTT MEDICAL | 2024-04-03 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S196) | W. L. Gore & Associates, Inc. | 2024-04-03 |
| 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/S777) | Medtronic, Inc. | 2024-04-02 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S043) | W. L. Gore & Associates, Inc. | 2024-04-02 |
| CardioMEMS Hospital System, model CM3100 (P100045/S074) | ABBOTT MEDICAL | 2024-04-02 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S076) | ABBOTT MEDICAL | 2024-04-01 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S102) | ABBOTT MEDICAL | 2024-04-01 |
| Axonics Sacral Neuromodulation System (P180046/S077) | Boston Scientific Corporation | 2024-04-01 |
| VENTANA PD-L1(SP142) Assay (P160002/S024) | Ventana Medical Systems, Inc. | 2024-04-01 |
| HeartSine's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S024) | Heartsine Technologies, Ltd. | 2024-04-01 |
| TriClip G4 System (P230007) | ABBOTT MEDICAL | 2024-04-01 |
| Axonics Sacral Neuromodulation System (P190006/S077) | Boston Scientific Corporation | 2024-04-01 |
| 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/S778) | Medtronic, Inc. | 2024-03-30 |
| enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S053) | Bausch & Lomb, Inc. | 2024-03-29 |
| LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034) | DiaSorin, Inc. | 2024-03-29 |
| HiResolution Bionic Ear System (P960058/S164) | Advanced Bionics | 2024-03-29 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter (P020045/S109) | Medtronic Cryocath, LP | 2024-03-29 |
| Aveir VR Leadless Pacemaker: Aveir Leadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker: Aveir Leadle (P150035/S008) | ABBOTT MEDICAL | 2024-03-29 |
| Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor (P100010/S145) | Medtronic Cryocath, LP | 2024-03-29 |
| OrganOx metra® System (P200035/S014) | Organox Limited | 2024-03-28 |
| Lead Repair Kit Model 6946 (P910073/S177) | Boston Scientific | 2024-03-28 |
| Akreos Posterior Chamber Intraocular Lens (P060022/S031) | Bausch & Lomb, Inc. | 2024-03-28 |
| iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100 (P080030/S026) | Glaukos Corporation | 2024-03-28 |
| Carotid WALLSTENT Monorail Endoprosthesis (P050019/S041) | Boston Scientific Corp | 2024-03-27 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S063) | Alcon Research, Ltd. | 2024-03-27 |
| TRANSCEND® Hip Articulation System (P010001/S027) | Ceramtec GmbH | 2024-03-27 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S084) | Alcon Laboratories | 2024-03-27 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S042) | W. L. Gore & Associates, Inc. | 2024-03-27 |
| (EZW) InterStim® Therapy System, Verify® Evaluation System (P970004/S395) | Medtronic Neuromodulation | 2024-03-27 |
| Accent, Assurity, Assurity+, Endurity, Endurity Core, Zenex, Zenus (P880086/S335) | ABBOTT MEDICAL | 2024-03-27 |
| Anthem,Allure, Allure Quadra, Quadra Allure (MRI Conditional),Quadra Allure MP (P030035/S200) | ABBOTT MEDICAL | 2024-03-27 |
| Assurity MRI, Endurity MRI,Zenex MRI (P140033/S087) | ABBOTT MEDICAL | 2024-03-27 |
| (QON) InterStim® Therapy System, Verify® Evaluation System (P080025/S290) | Medtronic Neuromodulation | 2024-03-27 |
| Artic Front Cryocatheter System (P100010/S146) | Medtronic Cryocath, LP | 2024-03-26 |
| Tendril STS, UltiPace (P960013/S124) | ABBOTT MEDICAL | 2024-03-26 |
| Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter (P200039/S014) | Shockwave Medical, Inc. | 2024-03-26 |
| Assurity MRI, Endurity MRI (P140033/S085) | ABBOTT MEDICAL | 2024-03-26 |
| ENROUTE Transcarotid Stent System (P140026/S029) | Boston Scientific Corporation | 2024-03-26 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S036) | Biotronik AG | 2024-03-26 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S019) | Biotronik AG | 2024-03-26 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S032) | Medtronic, Inc. | 2024-03-26 |