| cobas® HPV (P190028/S018) | Roche Molecular Systems, Inc. | 2024-09-27 |
| Alto Abdominal Stent Graft System (P120006/S044) | Endologix, LLC | 2024-09-27 |
| AFX2 Endovascular AAA System (P040002/S075) | Endologix, LLC | 2024-09-27 |
| ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (P200011/S002) | Pillar Biosciences | 2024-09-27 |
| Evolut FX Delivery Catheter System of the Medtronic Evolut FX System (P130021/S168) | Medtronic, Inc. | 2024-09-27 |
| cobas® HBV (P150014/S055) | Roche Molecular Systems, Inc. | 2024-09-27 |
| IsoFlex (P960030/S078) | ABBOTT MEDICAL | 2024-09-26 |
| Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas (P230005) | Motiva USA, LLC | 2024-09-26 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Relia IPG (P980035/S792) | Medtronic, Inc. | 2024-09-26 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S219) | Medtronic | 2024-09-26 |
| Novoste Beta-Cath System (P000018/S051) | Best Vascular, Inc. | 2024-09-26 |
| LIPOSORBER LA-15 System (P910018/S040) | Kaneka Pharma America Corp. | 2024-09-26 |
| Quartet (P030054/S424) | ABBOTT MEDICAL | 2024-09-26 |
| Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, Endurant IIs Stent Graft System, E (P100021/S123) | Medtronic Vascular | 2024-09-26 |
| RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S084) | Medtronic Vascular | 2024-09-26 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S046) | Biotronik AG | 2024-09-26 |
| Aveir VR Leadless Pacemaker: AveirLeadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker: Aveir Leadless (P150035/S014) | ABBOTT MEDICAL | 2024-09-26 |
| Quadra Allure, Quadra Allure MP (P030035/S203) | ABBOTT MEDICAL | 2024-09-26 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S066) | Medtronic Vascular | 2024-09-26 |
| OrganOx metra System (P200035/S015) | Organox Limited | 2024-09-26 |
| Tendril STS, UltiPace (P960013/S126) | ABBOTT MEDICAL | 2024-09-26 |
| Aveir Leadless System (Dual-Chamber) (P880086/S337) | ABBOTT MEDICAL | 2024-09-25 |
| LIFEPAK® 1000 Defibrillator (P160026/S051) | Physio-Control, Inc. | 2024-09-25 |
| CentriMag Circulatory Support System (P170038/S020) | Abbott | 2024-09-25 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG) (P110042/S198) | Boston Scientific Corporation | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P030054/S423) | ABBOTT MEDICAL | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P140033/S091) | ABBOTT MEDICAL | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P910023/S468) | ABBOTT MEDICAL | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P030035/S202) | ABBOTT MEDICAL | 2024-09-25 |
| Zenith® Alpha Thoracic Endovascular Graft (P140016/S010) | Cook Medical Incorporated | 2024-09-25 |
| Aveir Leadless System (Dual-Chamber) (P150035/S013) | ABBOTT MEDICAL | 2024-09-25 |
| Optune System (P100034/S035) | Novocure, GmbH | 2024-09-24 |
| Senza Spinal Cord Stimulation (SCS) System and HFX iQ System (P130022/S058) | Nevro Corporation | 2024-09-24 |
| Lava Liquid Embolic System (Lava LES) (P220020/S003) | Sirtex Medical, Inc. | 2024-09-24 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S042) | Biotronik AG | 2024-09-24 |
| TheraSphere (P200029/S010) | Boston Scientific Corporation | 2024-09-24 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-23 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D (P130013/S070) | Boston Scientific Corp | 2024-09-23 |
| EUFLEXXA (P010029/S040) | Ferring Pharmaceuticals, Inc. | 2024-09-23 |
| Atellica IM Prostate-Specific Antigen (PSA) (P950021/S029) | Siemens Healthcare Diagnostics | 2024-09-23 |
| Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S017) | MicroVention, Inc. | 2024-09-23 |
| Avive Automated External Defibrillator (AED) System (P210015/S003) | Avive Solutions, Inc. | 2024-09-23 |
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S147) | Merz North America, Inc. | 2024-09-23 |
| RADIESSE® Injectable Implant (P050037/S125) | Merz North America, Inc. | 2024-09-23 |
| Atellica IM Complexed PSA (cPSA) (P990055/S028) | Siemens Healthcare Diagnostics | 2024-09-23 |
| HeartMate 3 Left Ventricular Assist System (P160054/S082) | ABBOTT MEDICAL | 2024-09-23 |
| Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa ProMRI SD 6 (P980023/S129) | Biotronik, Inc. | 2024-09-21 |
| XPS with Steen Solution Perfusate (P180014/S011) | Xvivo Perfusion, Inc. | 2024-09-20 |
| BioMimics 3D Vascular Stent System (P180003/S010) | Veryan Medical, Ltd. | 2024-09-20 |
| Apollo Onyx Delivery Micro Catheter (P030004/S034) | Ev3 Neurovascular | 2024-09-20 |
| LCS® Total Knee System (P830055/S331) | Depuy, Inc. | 2024-09-20 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S133) | Abbott Vascular | 2024-09-20 |
| Neuroform Atlas® Stent System (P180031/S008) | Stryker Neurovascular | 2024-09-20 |
| Omnilink Elite Vascular Balloon-Expandable Stent System (P110043/S014) | Abbott Vascular-Cardiac Therapies | 2024-09-20 |
| Neuroform Atlas® Stent System (P180031/S007) | Stryker Neurovascular | 2024-09-20 |
| Pipeline Flex Embolization Device with Shield Technology, Pipeline Vantage Embolization Device with Shield Technology (P100018/S047) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-09-20 |
| Hintermann Series H3 Total Ankle Replacement System (P160036/S005) | Dt Medtech, LLC | 2024-09-20 |
| Shield (P230009/S001) | Guardant Health, Inc. | 2024-09-20 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S025) | Heartsine Technologies, Ltd. | 2024-09-20 |
| SpF® Implantable Spinal Fusion Stimulators (P850035/S059) | Ahp Eos Buyer, Inc. | 2024-09-20 |
| LifePulse High Frequency Ventilator (P850064/S054) | Bunnell, Inc. | 2024-09-19 |
| LCS® Total Knee System (P830055/S332) | Depuy, Inc. | 2024-09-19 |
| Axonics Sacral Neuromodulation System (P180046/S088) | Boston Scientific Corporation | 2024-09-18 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S105) | ABBOTT MEDICAL | 2024-09-18 |
| HeartMate 3 Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P160054/S086) | ABBOTT MEDICAL | 2024-09-18 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S224) | ABBOTT MEDICAL | 2024-09-18 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S789) | Medtronic, Inc. | 2024-09-18 |
| Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara (P010015/S544) | Medtronic, Inc. | 2024-09-18 |
| Axonics Sacral Neuromodulation System (P190006/S088) | Boston Scientific Corporation | 2024-09-18 |
| LifeVest® Wearable Defibrillator (P010030/S182) | Zoll Manufacturing Corporation | 2024-09-18 |
| HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P060040/S108) | ABBOTT MEDICAL | 2024-09-18 |
| Biofinity XR Sphere, Biofinity Energys Asphere, Biofinity Toric and Biofinity XR Torie and Biofinity Multifocal (comfilc (P080011/S171) | CooperVision, Inc. | 2024-09-17 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S052) | Medtronic Vascular, Inc. | 2024-09-17 |
| Simplera (TM) System (P160007/S052) | Medtronic Minimed | 2024-09-17 |
| INGEVITY + Leads - Active Fixation (P150012/S158) | Boston Scientific | 2024-09-16 |
| Axonics Sacral Neuromodulation System (P180046/S080) | Boston Scientific Corporation | 2024-09-16 |
| InterStim Therapy System (P970004/S405) | Medtronic Neuromodulation | 2024-09-16 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S485) | Medtronic, Inc. | 2024-09-16 |
| SynchroMed Infusion System (P860004/S431) | Medtronic, Inc. | 2024-09-16 |
| Filshie Clip (Mark VI) System (P920046/S014) | Femcare , Ltd. | 2024-09-16 |
| Master Spinal Cord Stimulation (SCS) Systems (P840001/S571) | Medtronic Neuromodulation | 2024-09-16 |
| Axonics Sacral Neuromodulation System (P190006/S080) | Boston Scientific Corporation | 2024-09-16 |
| Master Restore, Itrel® and VantaTM Spinal Cord Stimulation Systems (P840001/S572) | Medtronic Neuromodulation | 2024-09-16 |
| InterStim Therapy System (P080025/S300) | Medtronic Neuromodulation | 2024-09-16 |
| LIFEPAK 35 monitor/defibrillator (P160026/S052) | Physio-Control, Inc. | 2024-09-13 |
| Alinity m HBV Assay (P200013/S021) | Abbott Molecular, Inc. | 2024-09-13 |
| Alinity m HR HPV Assay (P230003/S004) | Abbott Molecular, Inc. | 2024-09-13 |
| Alinity m CMV Assay (P210022/S012) | Abbott Molecular, Inc. | 2024-09-13 |
| MED-EL Cochlear Implant System (P000025/S133) | Med-El Corp. | 2024-09-13 |
| MYNXGRIP Vascular Closure Device, MYNX CONTROL Vascular Closure Device (P040044/S103) | Cordis US Corporation | 2024-09-13 |
| R3TM delta Ceramic Acetabular System (P150030/S043) | Smith & Nephew, Inc. | 2024-09-13 |
| i-FACTOR® Peptide Enhanced Bone Graft (P140019/S011) | Cerapedics, LLC | 2024-09-13 |
| 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/S900) | Medtronic Cardiac Rhythm Disease Management | 2024-09-12 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S082) | Edwards Lifesciences, LLC | 2024-09-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S058) | Edwards Lifesciences, LLC | 2024-09-12 |
| EDWARDS INTUITY Elite Valve System (P150036/S076) | Edwards Lifesciences, LLC | 2024-09-12 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRTD, Cobalt M (P010031/S866) | Medtronic Cardiac Rhythm Disease Management | 2024-09-12 |
| Impella CP with SmartAssist, Impella 5.5 with SmartAssist (P140003/S118) | Abiomed, Inc. | 2024-09-12 |
| POLARx and POLARxFIT Cryoablation Catheters (P220032/S008) | Boston Scientific Corporation | 2024-09-12 |