| Organ Care System (OCS) Lung System (P160013/S016) | TransMedics, Inc. | 2024-01-09 |
| G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin (P120005/S091) | Dexcom, Inc. | 2024-01-09 |
| CentriMag Circulatory Support System (P170038/S012) | Abbott | 2024-01-09 |
| ReActiv8 Implantable Neurostimulation System (P190021/S001) | Mainstay Medical Limited | 2024-01-08 |
| Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor (P100010/S144) | Medtronic Cryocath, LP | 2024-01-08 |
| Master Activa®, Percept and SenSight Deep Brain Stimulation Therapy System (P960009/S438) | Medtronic, Inc. | 2024-01-08 |
| Cardiva VASCADE Family (P120016/S035) | Cardiva Medical, Inc. | 2024-01-08 |
| Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro) (P150038/S032) | Insightec | 2024-01-08 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter (P020045/S108) | Medtronic Cryocath, LP | 2024-01-08 |
| 4Kscore Test (P190022/S001) | Opko Health, Inc. | 2024-01-08 |
| Avalus Bioprosthesis (P170006/S024) | Medtronic, Inc. | 2024-01-08 |
| Pain RC Spinal Cord Stimulation System (SCS) System (P840001/S527) | Medtronic Neuromodulation | 2024-01-08 |
| Guardian Sensor 3, Guardian 4 Sensor (P160017/S115) | Medtronic Minimed, Inc. | 2024-01-05 |
| HiResolution Bionic Ear System (P960058/S163) | Advanced Bionics | 2024-01-05 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S023) | Philips Medical Systems, Inc. | 2024-01-05 |
| Guardian Sensor 3 (P160007/S050) | Medtronic Minimed | 2024-01-05 |
| Guardian Sensor 3 (P150001/S109) | Medtronic Minimed | 2024-01-05 |
| Impella CP, Impella CP with SmartAssist, Impella 2.5, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S116) | Abiomed, Inc. | 2024-01-05 |
| GEM21S (P040013/S029) | Lynch Biologics, LLC | 2024-01-04 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S102) | W. L. Gore & Associates, Inc. | 2024-01-03 |
| Cardiva VASCADE Family (P120016/S034) | Cardiva Medical, Inc. | 2024-01-03 |
| Guardian Sensor 3, Guardian 4 Sensor (P160017/S114) | Medtronic Minimed, Inc. | 2024-01-03 |
| OrganOx metra® System (P200035/S013) | Organox Limited | 2024-01-03 |
| Guardian Sensor 3 (P150001/S108) | Medtronic Minimed | 2024-01-03 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S163) | W. L. Gore & Associates, Inc. | 2024-01-03 |
| OPTIMIZER® Smart System (P180036/S026) | Impulse Dynamics (Usa), Inc. | 2024-01-03 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S001) | Surmodics,Inc. | 2024-01-03 |
| Butylated Hydroxytoluene (BHT) (P010012/S579) | Boston Scientific Corp | 2024-01-03 |
| Guardian Sensor 3 (P160007/S049) | Medtronic Minimed | 2024-01-03 |
| Seprafilm Adhesion Barrier (P950034/S057) | Baxter Healthcare Corporation | 2024-01-02 |