| LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers (P180039/S019) | DiaSorin, Inc. | 2025-01-06 |
| Precision7, Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (P220007/S006) | Alcon Laboratories, Inc. | 2025-01-06 |
| LIAISON Biotrin Parvovirus B19 lgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S003) | DiaSorin, Inc. | 2025-01-06 |
| LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM (P180045/S016) | DiaSorin, Inc. | 2025-01-06 |
| LIAISON XL Murex Anti-HBc and LIAISON XL MUREX Control anti-HBc (P180038/S020) | DiaSorin, Inc. | 2025-01-06 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S433) | Medtronic, Inc. | 2025-01-06 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S490) | Medtronic, Inc. | 2025-01-06 |
| Navitor Transcatheter Aortic Valve Implantation (TAVI) System (P190023/S024) | ABBOTT MEDICAL | 2025-01-06 |
| LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual (P190017/S022) | DiaSorin, Inc. | 2025-01-06 |
| Restore, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S577) | Medtronic Neuromodulation | 2025-01-06 |
| InterStim Therapy System, Verify Evaluation System (P080025/S304) | Medtronic Neuromodulation | 2025-01-06 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S556) | Medtronic, Inc. | 2025-01-03 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S007) | W. L. Gore & Associates, Inc. | 2025-01-03 |
| 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/S804) | Medtronic, Inc. | 2025-01-03 |
| MANTA Vascular Closure Device (P180025/S013) | Teleflex Medical, LLC | 2025-01-03 |
| Lumicell Direct Visualization System (DVS) (P230014/S003) | Lumicell, Inc. | 2025-01-03 |
| SIR-Spheres Y-90 resin microspheres (P990065/S016) | Sirtex Medical, Inc. | 2025-01-02 |
| Synvisc, Synvisc-One (P940015/S052) | Sanofi Genzyme Corp. | 2025-01-02 |
| Axonics Sacral Neuromodulation System (P190006/S084) | Boston Scientific Corporation | 2025-01-02 |
| Shield (P230009/S004) | Guardant Health, Inc. | 2025-01-02 |
| Biofinity XR Toric and Biofinity Toric Multifocal comfilcon A Soft (Hydrophilic) Contact Lenses (P080011/S177) | CooperVision, Inc. | 2025-01-02 |
| Axonics Sacral Neuromodulation System (P180046/S084) | Boston Scientific Corporation | 2025-01-02 |